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Ref. Ares(2025)1258969 - 17/02/2025 Annex I Scopes of designation and estimated minimum EU-wide capacity for tasks in points (a) and (b) of Article 100(2) of Regulation (EU) 2017/746 In 2022, the European Commission launched a first call for the designation of EU reference laboratories in 8 categories of class D devices (see main text of the call for the list of categories). Five laboratories were designed as EU reference laboratories covering four device categories (categories: 1, 2, 3, 5). For the remaining 4 categories (categories 4, 6, 7, 8), there were either no laboratories that satisfied the criteria or their combined capacity was insufficient to cover the expected volume of requests for tasks referred to in Article 100(2)(a) and (b) of Regulation (EU) 2017/746. Therefore, no EU reference laboratory was designated for these categories of devices following the first call. The current second call for applications will be run in two waves: 1) a first early application wave for the following currently not covered categories of class D devices: - detection or quantification of markers of arboviruses (category 4); - detection or quantification of markers of parasite infection (category 7); - detection of blood grouping markers (category 8); 2) a second wave open for all 8 categories of class D devices. The tables below list the estimated minimum EU-wide capacities for each device category for the two waves, for the EURL tasks referred to in Article 100(2) (a) and (b) of Regulation (EU) 2017/746. One or more of the categories 1-8 in these tables can constitute the scope of designation of the EU reference laboratories. Each category includes several groups of devices listed as 1.1, 1.2, 1.3 etc. A laboratory must cover as a minimum all the groups in the category it is designated for, and also any other devices falling in the category (with the exception of category 8, where only the listed groups must be covered). N.B.: It is possible for a device detecting/quantifying a given marker to fall into different risk classes depending on its intended purpose. For example, a device detecting Treponema pallidum can be class D if intended for screening blood donations or class C if intended to diagnose syphilis in the individual. The below devices are in scope of the EURL only if they fall in class D according to Annex VIII of Regulation (EU) 2017/746.  1. Categories and groups for the first application wave Category Category or group Estimated minimum Estimated minimum n°/ group capacity in terms of annual capacity in terms of annual n° EU-wide number of EU-wide number of submissions to EURL(s) submissions to EURL(s) according to Article according to Article 100(2)(a) of Regulation 100(2)(b) of Regulation (EU) (EU) 2017/746 2017/746 (batch testing) (performance verification) 4 Detection or quantification 14 200 of markers of arbovirus infection 4.1 West Nile virus 3 50 4.2 Dengue virus 5 50 4.3 Chikungunya virus 3 50 4.4 Zika virus 3 50 7 Detection or quantification 15 190 of markers of parasite infection 7.1 Plasmodium spp. 5 30 7.2 Trypanosoma cruzi 5 60 7.3 Toxoplasma gondii 5 100 8 Detection of blood 78 3150 grouping markers 8.1 ABO system 30 1500 8.2 Rhesus system 30 1000 8.3 Kell system 6 450 8.4 Kidd system 6 100 8.5 Duffy system 6 100  2. Categories and groups for the second application wave Category Category or group Estimated minimum Estimated minimum n°/ group capacity in terms of annual capacity in terms of annual n° EU-wide number of EU-wide number of submissions to EURL(s) submissions to EURL(s) according to Article according to Article 100(2)(a) of Regulation 100(2)(b) of Regulation (EU) (EU) 2017/746 2017/746 (batch testing) (performance verification) 1 Detection or quantification Detection: 84 Detection: 2705 of markers of hepatitis or Quantification: 29 Quantification: 1005 retrovirus infection 1.1 Human immunodeficiency Detection: 30 Detection: 800 virus 1/2 Quantification: 10 Quantification: 350 1.2 Hepatitis B virus Detection: 20 Detection: 1000 Quantification: 8 Quantification: 350 1.3 Hepatitis C virus Detection: 20 Detection: 500 Quantification: 10 Quantification: 300 1.4 Hepatitis D virus Detection: 5 Detection: 100 Quantification: 1 Quantification: 5 1.5 Hepatitis E virus Detection: 1 Detection: 5 1.6 Human T-cell lymphotropic Detection: 8 Detection: 300 virus I/II 2 Detection or quantification 16 500 of markers of herpesvirus infection 2.1 Cytomegalovirus 8 250 2.2 Epstein-Barr virus 8 250 3 Detection or quantification 8 200 of markers of infection with bacterial agents 3.1 Treponema pallidum 8 200 4 Detection or quantification 14 200 of markers of arbovirus infection 4.1 West Nile virus 3 50 4.2 Dengue virus 5 50 4.3 Chikungunya virus 3 50 4.4 Zika virus 3 50 5 Detection or quantification 45 220 of markers of respiratory virus infection 5.1 Highly virulent influenza 20 100 virus 5.2 Highly virulent coronavirus 25 120 (SARS, MERS) 6 Detection or quantification 15 65 of markers of infection with haemorrhagic fever viruses or other biosafety level 4 viruses 6.1 Ebola virus 3 15 6.2 Marburg virus 3 15 6.3 Lassa virus 3 15 6.4 Smallpox virus 3 10 6.5 Crimean-Congo 3 10 haemorrhagic fever virus 7 Detection or quantification 15 190 of markers of parasite infection 7.1 Plasmodium spp. 5 30 7.2 Trypanosoma cruzi 5 60 7.3 Toxoplasma gondii 5 100 8 Detection of blood 78 3150 grouping markers 8.1 ABO system 30 1500 8.2 Rhesus system 30 1000 8.3 Kell system 6 450 8.4 Kidd system 6 100 8.5 Duffy system 6 100 Ref. Ares(2025)1258969 - 17/02/2025 Annex II Instructions for submitting the application 1. For the first application wave, Member States are requested to submit the applications not later than 12:00 (midday) Central European Time on 6 June 2025. No extension of the deadline is possible. Applications submitted after the deadline will be considered in the second application wave. It is highly recommended that candidate laboratories send their applications to their Member States no later than 12:00 (midday) Central European Time on 15 April 2025. 2. For the second application wave, Member States are requested to submit the applications not later than 12:00 (midday) Central European Time on 15 April 2026. No extension of the deadline is possible. Applications submitted after the deadline will not be considered. It is highly recommended that candidate laboratories send their applications to their Member States no later than 12:00 (midday) Central European Time on 15 January 2026. 3. Member States must carefully follow the instructions in this call. 4. Only applications submitted by the Member States or the European Commission’s Joint Research Centre (JRC) and for which they have verified the compliance with selection criteria will be considered. 5. Member States or the JRC must complete and submit the following documents: • Application form (Annex III or Annex IV) • Visa section Declaration on honour regarding exclusion criteria (Annex V) • Visa section of Declaration of independence of the candidate laboratory (Annex VII) • Template for verification of compliance with selection criteria (Annex X) • Confirmation of the Member States regarding the performance of tasks in the public interest and in an independent manner (Annex XI) In addition, Member States are responsible for submitting the supporting documents referred to in sections 3 and 4 of this call, as prepared by the candidate laboratories. Supporting documents for the selection criteria in section 3 are requested at the initial application stage, by the above deadline. Supporting documents for the preference criteria in section 4 might be requested by the European Commission at a later stage and only in case of need. 6. The application must be submitted electronically via Secure CIRCABC. Each Member State will have its own dedicated folder in the relevant Secure CIRCABC Interest Group. Individual Member State representatives will need to have a personal EU Login account 1 that will be granted for accessing this folder. To nominate up to 3 Member States representatives for access to the CIRCABC Interest group, please send an email to: JRC- 1 EU Login accounts can be created at https://webgate.ec.europa.eu/cas/about.html  [email protected] with their name/surname and email addresses. Accessing Secure CIRCABC requires EU Login with 2-factors authentication methods (e.g. Mobile Phone + SMS)2. Then proceed with the following steps: • Access the Secure CIRCABC Interest Group at https://classified.circabc.europa.eu/ • On the top Menu click Library, then click the folder of the Member State • Click the Button ADD and select FILES • Select the file(s) to be uploaded by clicking ADD FILES or simply dragging and dropping the file(s) in the dashed area • Click UPLOAD and then FINISH Applications submitted by other means will not be considered. For technical assistance during the submission, please send an email to: [email protected] 2 To add a mobile phone number to a EU Login account, login to https://webgate.ec.europa.eu/cas/about.html Click to gear icon beside the user name (at the top right of the page). Click My Account page and then Manage my mobile phone numbers Annex V Declaration on honour regarding exclusion criteria (point 9.7 of the selection criteria) Full official name of the candidate laboratory: …………………………. Full address of the candidate laboratory: ………………………. I, the undersigned, [insert name] ……………………..……, [insert function of the undersigned in the laboratory] …………………………….., and thus legally authorised representative of the abovementioned laboratory vis-à-vis third parties and acting on behalf of that laboratory, in the context of the call for applications for designation of EU reference laboratories in the field of in vitro diagnostic medical devices according to Article 100 of Regulation (EU) 2017/746, declare that the candidate laboratory mentioned above is not in any of the following situations for exclusion set out in Article 136 of Regulation (EU) 2018/1046 : (a) the person or entity is bankrupt, subject to insolvency or winding-up procedures, its assets are being administered by a liquidator or by a court, it is in an arrangement with creditors, its business activities are suspended, or it is in any analogous situation arising from a similar procedure provided for under Union or national law; (b) it has been established by a final judgment or a final administrative decision that the person or entity is in breach of its obligations relating to the payment of taxes or social security contributions in accordance with the applicable law; (c) it has been established by a final judgment or a final administrative decision that the person or entity is guilty of grave professional misconduct by having violated applicable laws or regulations or ethical standards of the profession to which the person or entity belongs, or by having engaged in any wrongful conduct which has an impact on its professional credibility where such conduct denotes wrongful intent or gross negligence, including, in particular, any of the following: (i) fraudulently or negligently misrepresenting information required for the verification of the absence of grounds for exclusion or the fulfilment of eligibility or selection criteria or in the implementation of the legal commitment; (ii) entering into agreement with other persons or entities with the aim of distorting competition; (iii) violating intellectual property rights; (iv) attempting to influence the decision-making of the authorising officer responsible during the award procedure; (v) attempting to obtain confidential information that may confer upon it undue advantages in the award procedure; (d) it has been established by a final judgment that the person or entity is guilty of any of the following: (i) fraud, within the meaning of Article 3 of Directive (EU) 2017/1371 of the European Parliament and of the Council and Article 1 of the Convention on the protection of the European Communities’ financial interests, drawn up by the Council Act of 26 July 1995; (ii) corruption, as defined in Article 4(2) of Directive (EU) 2017/1371 or active corruption within the meaning of Article 3 of the Convention on the fight against corruption involving officials of the European Communities or officials of Member States of the European Union, drawn up by the Council Act of 26 May 1997, or conduct referred to in Article 2(1) of Council Framework Decision 2003/568/JHA, or corruption as defined in other applicable laws; (iii) conduct related to a criminal organisation as referred to in Article 2 of Council Framework Decision 2008/841/JHA; (iv) money laundering or terrorist financing within the meaning of Article 1(3), (4) and (5) of Directive (EU) 2015/849 of the European Parliament and of the Council; (v) terrorist offences or offences linked to terrorist activities, as defined in Articles 1 and 3 of Council Framework Decision 2002/475/JHA, respectively, or inciting, aiding, abetting or attempting to commit such offences, as referred to in Article 4 of that Decision; (vi) child labour or other offences concerning trafficking in human beings as referred to in Article 2 of Directive 2011/36/EU of the European Parliament and of the Council; (e) the person or entity has shown significant deficiencies in complying with main obligations in the implementation of a legal commitment financed by the budget which has: (i) led to the early termination of a legal commitment; (ii) led to the application of liquidated damages or other contractual penalties; or (iii) been discovered by an authorising officer, OLAF or the Court of Auditors following checks, audits or investigations; (f) it has been established by a final judgment or final administrative decision that the person or entity has committed an irregularity within the meaning of Article 1(2) of Council Regulation (EC, Euratom) No 2988/95; (g) it has been established by a final judgment or final administrative decision that the person or entity has created an entity in a different jurisdiction with the intent to circumvent fiscal, social or any other legal obligations in the jurisdiction of its registered office, central administration or principal place of business; (h) it has been established by a final judgment or final administrative decision that an entity has been created with the intent referred to in point (g). Full name: Date: Signature: __________________________________________________________________________ Visa of the Member State where the laboratory is located: Member State: Name of competent authority: Name of contact person: Signature: Date: Ref. Ares(2025)1258969 - 17/02/2025 Criteria used for evaluation of economic and financial capacity On the basis of the data from the 'Simplified Presentation' form in Annex VI B, a number of values and ratios will be calculated in order to evaluate the economic and financial capacity of the candidate. The following values will be calculated: Value Formula/source Unfavourable if: own funds from the balance sheet negative own funds - paid-up capital negative working capital permanent capital - fixed assets negative gross operating surplus from the P&L accounts negative net result from the P&L accounts negative self-financing capacity net result after tax + amortization – (SFC) capitalized production negative Following ratios are calculated: Unfavourable Favourable Ratio Formula if Average if if general current assets/short- between 1 liquidity term debts below 1 and 1.25 Above 1.25 financial own funds/total between 0.20 independence liabilities below 0.20 and 0.40 above 0.40 own funds/medium & long-term debts between 0.30 indebtedness (MLT) below 0.30 and 0.60 above 0.60 coverage of deposits and borrowed funds between 0.25 by the SFC SFC / MLT debts below 0.25 and 0.50 above 0.50 gross operating between 0.10 profitability surplus / turnover below 0.10 and 0.20 above 0.20 Each type of evaluation has a corresponding scoring (number of points) as follows: Scoring Unfavourable value/ratio 0 points Favourable value 1 point Average ratio 1 point Favourable ratio 2 points If, for some exceptional reason which the Commission considers justified, the candidate is unable to provide the references requested by the Commission, or if he feels that the financial viability check does not provide an accurate picture of his organisation's financial status, he may prove his economic and financial capacity by any other means which the Commission considers appropriate. Annex VII Declaration of independence of the candidate laboratory (point 13.1 of the selection criteria) Full name of the candidate laboratory: …………………………. Full address of the candidate laboratory: ………………………. I, the undersigned, [insert name] ……………………..……, [insert function of the undersigned in the laboratory] …………………………….., and thus legally authorised representative of the abovementioned laboratory vis-à-vis third parties and acting on behalf of that laboratory, in the context of the call for applications for designation of EU reference laboratories in the field of in vitro diagnostic medical devices according to Article 100 of Regulation (EU) 2017/746, declare that the candidate laboratory mentioned above , if designated, will not : be the designer, manufacturer, supplier, installer, purchaser, owner or maintainer of devices within the proposed scope of designation, nor the authorised representative of any of those parties; be involved in the design, manufacture or construction, marketing, installation, use or maintenance of the devices within the proposed scope of designation; be a notified body for devices within the proposed scope of designation; perform any tasks related to conformity assessment under Regulation (EU) 2017/746 on request of a notified body, other than the tasks referred to in Article 100(2) of Regulation (EU) 2017/746, within the scope of designation of the laboratory. enter into collaboration with a device manufacturer or a notified body concerning a joint commercial exploitation, if such collaboration falls within the scope of its designation. Full name: Date: Signature: __________________________________________________________________________ Visa of the Member State where the laboratory is located: Member State: Name of competent authority: Name of contact person: Signature: Date: Annex VIII Application form for single laboratories Nominating Member State: …………………………………………… ….. Competent authority: …………………………………………………………. Contact person regarding this application in the Member State: Name: ……………………………………………………… Email:… ………………………………………………… Phone number:… ……………………………………….. Full name of candidate laboratory in English: …………………………………… ….. Full name of candidate laboratory in national language:… ……………………………………. Address of candidate laboratory: ………………………………………………………. Please fill in either Table 1 or Table 2 depending on the application wave. Table 1: P roposed scope of designation for the laboratory applying as part of the first application wave No Category Please tick 4 Detection or quantification of markers of arbovirus infection 7 Detection or quantification of markers of parasite infection 8 Detection of blood grouping markers Table 2 : P roposed scope of designation for the laboratory applying as part of the second application wave No Category Please tick 1 Detection or quantification of markers of hepatitis or retrovirus infection 2 Detection or quantification of markers of herpesvirus infection 3 Detection or quantification of markers of infection with bacterial agents 4 Detection or quantification of markers of arbovirus infection 5 Detection or quantification of markers of respiratory virus infection 6 Detection or quantification of markers of infection with haemorrhagic fever viruses or other biosafety level 4 viruses 7 Detection or quantification of markers of parasite infection 8 Detection of blood grouping markers Annex X Template for verification of compliance with the selection criteria by the Member State Nominating Member State: …………………………………………… ….. Competent authority: …………………………………………………………. Single laboratory application Consortium application – Please fill a separate verification template for each member of the consortium Full name of candidate laboratory in English: …………………………………… ….. Full name of candidate laboratory in national language:… ………………………………… The candidate laboratory is accredited in accordance with EN ISO/IEC 17025: No – Please fill Table 1 starting on page 2 . Yes – Issuing entity, date and number of certificate : …………………………………………. In accordance with the above accreditation and Article 8 of the Commission Implementing Regulation 2022/944, the nominating Member State may grant presumption of conformity to the candidate laboratory for certain requirements set out in the Regulation 2022/944. Presumption of conformity is granted: Yes – P lease fill Table 2 and 3 starting on page 7. No – P lease fill Table 1 starting on page 2. Table 1 : Verification table for candidate laboratories without ISO 17025 accreditation in scope of the EURL application Criterion No Means of proof Supporting documents provided. Please tick if yes and specify the document name Member State verification. Are the documents compliant with the selection criteria? Justification / Comments - if any 1.1 List of knowledge and experience requirements for the director, the scientific staff and the technical staff document(s) name: yes no 2.1 Overview tables for knowledge and experience of the staff and the supporting documents document(s) name: yes no 3.1 Estimate of minimum capacity regarding performance verification document(s) name: yes no 3.2 Estimate of minimum capacity regarding batch testing document(s) name: yes no 3.3 Justification regarding the number of staff document(s) name: yes no 4.1 Description of the continuous training and education programme for the staff document(s) name: yes no 5.1 Justification regarding equipment and reference materials document(s) name: yes no 5.2 Evidence of possession of equipment and reference materials document(s) name: yes no 5.3 Plan for procurement of specimens, control materials and reference materials document(s) name: yes no 6.1 List of international standards and best practices, including common specifications document(s) name: yes no 6.2 Evidence of integration international standards and best practices, including common specifications document(s) name: yes no 7.1 Identification of the person having overall responsibility document(s) name: yes no 8.1 Estimate regarding volume of administrative work document(s) name: yes no 8.2 Justification of the number of administrative staff document(s) name: yes no 9.1 Evidence of the laboratory’s status as a legal entity document(s) name: yes no 9.2 If the laboratory is part of a larger organisation, information related to that larger organisation If applicable: document(s) name: yes no 9.3 If the laboratory is, directly or indirectly, controlled by other entities, the identity of such entities and their controlling position If applicable: document(s) name: yes no 9.4 Description of the laboratory’s internal organisational structure document(s) name: yes no 9.5 Description of the operating procedures document(s) name: yes no 9.6 Evidence of sources of funding document(s) name: yes no 9.7 Declaration on honour regarding exclusion criteria Candidate declaration Member State visa document(s) name: yes no 9.8.1 Economic viability template document(s) name: yes no 9.8.2 Balance sheets, profit and loss accounts or annual reports for the last three financial years document(s) name: yes no 9.8.3 Audit reports from the last three financial years Where available: document(s) name: yes no 9.9 Proposed system for records of costs and fees document(s) name: yes no 10.1 Confidentiality policy including the following: document(s) name: yes no 10.1.1 the type of information that is considered confidential document(s) name: yes no 10.1.2 rules for the appropriate secure handling, storage and processing of confidential information and measures to prevent undue disclosure document(s) name: yes no 10.1.3 rules for sharing of confidential and non-confidential information with staff, and the public document(s) name: yes no 10.1.4 rules for granting access to confidential information to a competent authority of a Member State upon its request in the context of market surveillance or vigilance activities by the competent authority document(s) name: yes no 10.1.5 rules for sharing confidential information, on the initiative of the EU reference laboratory, with a competent authority of a Member State and with the European Commission where the EU reference laboratory has reason to believe that such sharing is in the interest of protection of public health document(s) name: yes no 10.2 List of measures to ensure that the staff complies with the confidentiality policy document(s) name: yes no 11.1 Confirmation by the Member States regarding the performance of tasks in the public interest and in an independent manner document(s) name: yes no 12.1 Policy for the management of conflict of interest document(s) name: yes no 13.1 Declaration of independence of the candidate laboratory Candidate declaration Member State visa document(s) name: yes no 14.1 List of requirements regarding the tasks covered by the contract If applicable: document(s) name: yes no 14.2 Declaration regarding the external laboratories If applicable: document(s) name: yes no Table 2 : Verification table 1 for candidate laboratories with ISO 17025 accreditation in the scope of the EURL application Criterion No Member State granted presumption of conformity for the following Articles of Regulation (EU) 2022/944 to the EN ISO/IEC 17025 accredited candidate laboratory 1.1 List of knowledge and experience requirements for the director, the scientific staff and the technical staff Article 1(1) 2.1 Overview tables for knowledge and experience of the staff and the supporting documents Article 1(2) 3.3 Justification regarding the number of staff Article 1(3) 4.1 Description of the continuous training and education programme for the staff Article 1(4) 5.2 Evidence of possession of equipment and reference materials Article 2(1), point (b) 7.1 Identification of the person having overall responsibility Article 4(1) 8.1 Estimate regarding volume of administrative work Article 4(2) 8.2 Justification of the number of administrative staff Article 4(2) 9.1 Evidence of the laboratory’s status as a legal entity Article 4(3), point (a) 9.4 Description of the laboratory’s internal organisational structure Article 4(3), point (d) 9.5 Description of the operating procedures Article 4(3), point (e) 10.1 Confidentiality policy including the following: 10.1.1 the type of information that is considered confidential Article 5(1), point (a) 10.1.2 rules for the appropriate secure handling, storage and processing of confidential information and measures to prevent undue disclosure Article 5(1), point (b) 10.1.3 rules for sharing of confidential and non-confidential information with staff, and the public Article 5(1), point (c) 10.2 List of measures to ensure that the staff complies with the confidentiality policy Article 5(2) 12.1 Policy for the management of conflict of interest Article 6(2) 14.2 Declaration regarding the external laboratories Article 7(3), point (a), (b), (c) Certificate of accreditation according to EN ISO/IEC 17025 Certificate provided Table 3 Verification table 2 for candidate laboratories with ISO 17025 accreditation in the scope of the EURL application Criterion No Means of proof Supporting documents provided. Please tick if yes and specify the document name Member State verification. Are the documents compliant with the selection criteria? Justification / Comments - if any 3.1 Estimate of minimum capacity regarding performance verification document(s) name: yes no 3.2 Estimate of minimum capacity regarding batch testing document(s) name: yes no 5.1 Justification regarding equipment and reference materials document(s) name: yes no 5.3 Plan for procurement of specimens, control materials and reference materials document(s) name: yes no 6.1 List of international standards and best practices, including common specifications document(s) name: yes no 6.2 Evidence of integration international standards and best practices, including common specifications document(s) name: yes no 9.2 If the laboratory is part of a larger organisation, information related to that larger organisation If applicable: document(s) name: yes no 9.3 If the laboratory is, directly or indirectly, controlled by other entities, the identity of such entities and their controlling position If applicable: document(s) name: yes no 9.6 Evidence of sources of funding document(s) name: yes no 9.7 Declaration on honour regarding exclusion criteria Candidate declaration Member State visa document(s) name: yes no 9.8.1 Economic viability template document(s) name: yes no 9.8.2 Balance sheets, profit and loss accounts or annual reports for the last three financial years document(s) name: yes no 9.8.3 Audits reports from the last three financial years Where available: document(s) name: yes no 9.9 Proposed system for records of costs and fees document(s) name: yes no 10.1 Confidentiality policy including the following: 10.1.4 rules for granting access to confidential information to a competent authority of a Member State upon its request in the context of market surveillance or vigilance activities by the competent authority document(s) name: yes no 10.1.5 rules for sharing confidential information, on the initiative of the EU reference laboratory, with a competent authority of a Member State and with the European Commission where the EU reference laboratory has reason to believe that such sharing is in the interest of protection of public health document(s) name: yes no 11.1 Confirmation by the Member States regarding the performance of tasks in the public interest and in an independent manner document(s) name: yes no 13.1 Declaration of independence of the candidate laboratory Candidate declaration Member State visa document(s) name: yes no 14.1 List of requirements regarding the tasks covered by the contract If applicable: document(s) name: yes no Ref. Ares(2025)1258969 - 17/02/2025 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY SECOND CALL FOR APPLICATIONS FOR DESIGNATION OF EU REFERENCE LABORATORIES IN THE FIELD OF IN VITRO DIAGNOSTIC MEDICAL DEVICES TERMS OF REFERENCE 1 Contents 1 INTRODUCTION ........................................................................................................................................ 3 1.1 Purpose ................................................................................................................................................. 3 1.2 Legal framework ................................................................................................................................. 3 2 THE PROCEDURE FOR SUBMISSION OF APPLICATIONS AND SELECTION OF EU REFERENCE LABORATORIES ....................................................................................................................... 6 2.1 General procedure ............................................................................................................................... 6 2.2 Modalities applicable in case of the expression of interest by a consortium .................................. 7 3 SELECTION CRITERIA ............................................................................................................................ 8 4 PREFERENCE CRITERIA .......................................................................................................................14 5 SELECTION................................................................................................................................................15 2 1 INTRODUCTION 1.1 Purpose The purpose of this second call for applications is to invite Member States and the European Commission’s Joint Research Centre (JRC) to submit applications for laboratories in the respective Member State or at JRC in view of their possible designation as EU reference laboratories in the area of in vitro diagnostic medical devices according to Article 100 of Regulation (EU) 2017/7461. In 2022, the European Commission launched a first call for the designation of EU reference laboratories in 8 categories of class D devices: 1 - Detection or quantification of markers of hepatitis or retrovirus infection 2 - Detection or quantification of markers of herpesvirus infection 3 - Detection or quantification of markers of infection with bacterial agents 4 - Detection or quantification of markers of arbovirus infection 5 - Detection or quantification of markers of respiratory virus infection 6 - Detection or quantification of markers of infection with haemorrhagic fever viruses or other biosafety level 4 viruses 7 - Detection or quantification of markers of parasite infection 8 - Detection of blood grouping markers Following the evaluation process, the European Commission designated 5 EU reference laboratories covering the categories 1, 2, 3 and 5. For the remaining 4 categories (4, 6, 7 and 8) there were either no laboratories that satisfied the criteria or their combined capacity was insufficient to cover the expected volume of requests for tasks referred to in Article 100(2)(a) and (b) of Regulation (EU) 2017/746. Therefore, no EU reference laboratory was designated for these categories of devices following the first call. The current second call for applications will be run in two waves: 1) a first early application wave for the following currently not covered categories of class D devices: - detection or quantification of markers of arboviruses (category 4); - detection or quantification of markers of parasite infection (category 7); - detection of blood grouping markers (category 8); 2) a second wave open for all 8 abovementioned categories of class D devices. Designated EU reference laboratories will address one or more of the specific categories of class D in vitro diagnostic medical devices referred to in Annex I of this call. These categories will constitute the scope of designation of the laboratories. Each category includes several groups of devices also listed in Annex I. A laboratory must cover as a minimum all the listed groups in the category it is designated for, and also any other devices falling in the category (with the exception of category 8, where only the listed groups must be covered). 1 Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU 3 Candidate laboratories must provide evidence of compliance with the criteria set out in Article 100(4) of Regulation (EU) 2017/746, as further specified by Commission Implementing Regulation (EU) 2022/944 on tasks and criteria of EU reference laboratories2, for the intended scope of designation. Please refer to Annex II for the timing of the waves for Member States and candidate laboratories. This call does not constitute an obligation on the European Commission to designate the EU reference laboratories or award a financial contribution. 1.2 Legal framework Tasks of EU reference laboratories Pursuant to Article 100(2) of Regulation (EU) 2017/746, the tasks of EU reference laboratories, within the scope of their designation, are the following: (a) to verify the performance claimed by the manufacturer and the compliance of class D devices with the applicable CS3, when available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent, as provided for in the third subparagraph of Article 48(3); (b) to carry out appropriate tests on samples of manufactured class D devices or batches of class D devices, as provided for in the Section 4.12 of Annex IX and in Section 5.1 of Annex XI; (c) to provide scientific and technical assistance to the Commission, the MDCG4, the Member States and notified bodies in relation to the implementation of this Regulation; (d) to provide scientific advice regarding the state of the art in relation to specific devices, or a category or group of devices; (e) to set up and manage a network of national reference laboratories after consulting with the national authorities and publish a list of the participating national reference laboratories and their respective tasks; (f) to contribute to the development of appropriate testing and analysis methods to be applied for conformity assessment procedures and market surveillance; (g) to collaborate with notified bodies in the development of best practices for the performance of conformity assessment procedures; 2 Commission Implementing Regulation (EU) 2022/944 of 17 June 2022 laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the tasks of and criteria for European Union reference laboratories in the field of in vitro diagnostic medical devices (Text with EEA relevance) 3 CS: Common specifications. List of common specifications adopted under the Regulation (EU) 2017/746: Commission Implementing Regulation (EU) 2022/1107 4 MDCG: Medical Device Coordination Group 4 (h) to provide recommendations on suitable reference materials and reference measurement procedures of higher metrological order; (i) to contribute to the development of CS and of international standards; (j) to provide scientific opinions in response to consultations by notified bodies in accordance with this Regulation and publish them by electronic means having considered national provisions on confidentiality. In addition, in accordance with Article 100(5) of Regulation (EU) 2017/746 the EU reference laboratories must form a network in order to coordinate and harmonise their working methods as regards testing and assessment. That coordination and harmonisation will involve: (a) applying coordinated methods, procedures and processes; (b) agreeing on the use of same reference materials and common test samples and seroconversion panels; (c) establishing common assessment and interpretation criteria; (d) using common testing protocols and assessing the test results using standardised and coordinated evaluation methods; (e) using standardised and coordinated test reports; (f) developing, applying and maintaining a peer review system; (g) organizing regular quality assessment tests (including mutual checks on the quality and comparability of test results); (h) agreeing on joint guidelines, instructions, procedural instructions or standard operational procedures; (i) coordinating the introduction of testing methods for new technologies and according to new or amended CS; (j) reassessing the state of the art on the basis of comparative test results or by further studies, as requested by a Member State or by the Commission. Designation of EU reference laboratories In accordance with Article 100(1) of Regulation (EU) 2017/746 the European Commission may designate, by means of implementing acts, one or more EU reference laboratories for specific devices, or a category or group of devices, or for specific hazards related to a category or group of devices. The European Commission shall only designate the EU reference laboratories for which a Member State or the European Commission’s Joint Research Centre has submitted an application for designation. 5 The European Commission will designate the EU reference laboratories for a minimum period of 5 years with extension subject to continued compliance with the criteria. The European Commission may, by implementing act, suspend, withdraw or restrict the designation in case of non-compliance (see Article 100(9) of Regulation (EU) 2017/746). Financing of EU reference laboratories According to Article 100(7) of Regulation (EU) 2017/746, where notified bodies or Member States request scientific or technical assistance or a scientific opinion from an EU reference laboratory, the EU reference laboratory may charge fees to cover the costs incurred by the laboratory in carrying out the requested task according to predetermined and transparent terms and conditions. The Commission Implementing Regulation (EU) 2022/945 on the fees that may be levied by EU reference laboratories5 identifies the categories of costs eligible to be covered by fees. Given the wide variety of in vitro diagnostic devices on the EU market and the various tasks that can be assigned to EU reference laboratories, the calculation of the exact fee for each task is at the discretion of the EU reference laboratories. The EU reference laboratories must determine the rules according to which they calculate the fees for carrying out the requested tasks, including the rules for the estimation of incurred costs based on average costs, and make them publicly available. The fee levying system and related documentation will be subject to controls referred to in Article 100(9) of Regulation (EU) 2017/746. As laid down in Article 100(6) of Regulation (EU) 2017/746, the EU reference laboratories may be granted a Union financial contribution. The European Commission may set out detailed arrangements and the amount of this contribution by means of implementing acts. The European Commission will consider the establishment of the Union contribution following designation of EU reference laboratories and evaluation of the needs for funding. It may in particular cover the tasks of the EU reference laboratories not funded by fees and tasks of the network of EU reference laboratories referred to in Article 100(5) of Regulation (EU) 2017/746. 2 THE PROCEDURE FOR SUBMISSION OF APPLICATIONS AND SELECTION OF EU REFERENCE LABORATORIES 2.1 General procedure 1. The call is available in English only. English will be the working language for this call and applications must be completed in English. Supporting documents should as much as possible be provided in English, except where it would be inappropriate, such as national accreditation certificates or other proof of competence in the form of certificates. 5 Commission Implementing Regulation (EU) 2022/945 of 17 June 2022 laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and the Council with regard to fees that may be levied by EU reference laboratories in the field of in vitro diagnostic medical devices (Text with EEA relevance) 6 2. The Member State and the candidate laboratory must decide on the proposed scope of designation of the laboratory by selecting one or more categories of devices listed in Annex I. The candidate laboratory must estimate its minimum capacity for tasks referred to in points (a) and (b) of Article 100(2) of Regulation (EU) 2017/746 for each group of devices in the selected category or categories. The Member State may submit the application if the laboratory either partially or fully covers the estimated minimum EU-wide capacity for those tasks as set out in Annex I. Please note that in case the laboratory only partially covers the estimated minimum EU-wide capacity for a group of devices, its designation for the corresponding category may also be conditional on availability of other candidates who fulfil the selection criteria. 3. The selection criteria for EU reference laboratories in the field of in vitro diagnostic medical devices are outlined in Section 3 of this call. The preference criteria are listed in Section 4. 4. As laid down in Article 100(1) of Regulation (EU) 2017/746, Member States are responsible for submitting the completed application forms and supporting documentation for the selection criteria for candidate laboratories they wish to propose to be designated as EU reference laboratories to the European Commission. Supporting documentation for the preference criteria must be submitted at a later stage only by those candidate laboratories for which an assessment of preference criteria will be necessary, i.e. in case there are more candidate laboratories for a category of devices with significantly higher collective capacity than the estimated minimum EU-wide capacity. Please see Annex II for the detailed instructions for submitting the application. 5. Before submitting the applications to the European Commission, the Member States must verify that the candidate laboratory complies with the selection criteria in section 3. The Member States must document the verification and its outcome in the template for verification of compliance with the selection criteria, provided in Annex X. 6. A selection panel will be set up by the European Commission services. The panel will check the verification of compliance with selection criteria performed by the Member States or the European Commission’s Joint Research Centre for consistency and completeness. The panel will also apply the preference criteria in case there are more candidate laboratories for a category with considerably higher collective capacity than the estimated minimum EU-wide capacity. 7. In case of need for minor clarification about the submitted application, supporting documents or the verification template, the selection panel will contact the candidate laboratory or the Member State, respectively. 8. In order to be designated, the candidates must satisfy all the selection criteria. In addition, the European Commission will seek to ensure that for each group of devices listed in Annex I, the collective capacity of the designated EU reference laboratories corresponds to a reasonable extent to the estimated minimum EU-wide capacity for tasks referred to in points (a) and (b) of Article 100(2) of Regulation (EU) 2017/746, as set out in Annex I. 7  Where several candidates fulfil all the selection criteria, and whose collective capacity is significantly higher than the estimated minimum EU-wide capacity for tasks referred to in points (a) and (b) of Article 100(2) of Regulation (EU) 2017/746, as set out in Annex I, then the preference criteria will be used to select the laboratories with the highest scores whose collective capacity corresponds to a reasonable extent to the estimated minimum EU-wide capacity. In cases where the preference criteria need to be applied, the European Commission will contact the relevant Member States with a request for candidate laboratories to submit them within a specified deadline. 9. The Member States will be informed about the outcome of the selection. 10. Thereafter, as laid down in Article 100(1) of Regulation (EU) 2017/746, the European Commission will designate the selected EU reference laboratories by means of an implementing act. The act will identify the laboratories and the scope of the designation, i.e. the categories of devices each of them will cover. 11. During the evaluation period, only contacts between the European Commission services and Member States will take place. Candidate laboratories must contact their Member States for information. 12. Submission of an application following this call implies acceptance by the candidate laboratory and Member State of all provisions and conditions stipulated in this call. 13. The European Commission services will not reimburse any expenses incurred in preparing and submitting applications. 2.2 Modalities applicable in case of the expression of interest by a consortium For the purpose of this call, a "consortium" is defined as 'two or more entities in one or more Member States working together to perform the EU reference laboratory tasks for the same category or categories of devices, as referred to in Annex I of the call'. Individual consortium members may cover some of the groups within the category. The consortium as a whole must cover the entire selected category or categories. Specific requirements for consortia in addition to the ones foreseen for single entities: 1. A single application must be submitted for a consortium. In case the entities are located in different EU Member States, the application must be submitted jointly by all relevant Member States. 2. Each member of the consortium must meet all selection criteria. 3. The consortium must nominate a coordinator who will be the leading entity and general contact point. 4. Consortium members must authorise the coordinator to represent the consortium on their behalf. 8 5. Consortium members must authorise the coordinator to receive and distribute possible financial contributions received from the European Commission according to a distribution key agreed among consortium members, which will be described in the work programme. 6. Each member of the consortium must include in the application an accession letter with the following: • confirmation of its participation in the consortium; • indication of the specific area of participation; • statement as to which entity has been nominated as the coordinator of the consortium; • indications that the authorisations referred to in points 4 and 5 above have been granted. 7. Each member of the consortium must submit all documents requested for the selection criteria as part of the single application. 8. For the preference criteria only, the consortium must submit a single jointly elaborated set of documents. The work programme of the consortium has to contain a demonstration of coherence and complementarity within the consortium members including task division, decision-making process and the exchange of knowledge. 9. Technical liability: the consortium members are jointly and severally liable for carrying out the tasks of the EU reference laboratory. If a consortium member fails to implement its part of the tasks, the other members become responsible for implementing this part. 10. Financial liability: the consortium members maintain individual financial liability. 3 SELECTION CRITERIA Candidate laboratories must satisfy the following selection criteria as demonstrated by the corresponding means of proof and supporting documents. No Criterion Means of proof 1 The candidate laboratories must document 1.1 List of knowledge and experience and justify the knowledge and experience requirements and the justification requirements for staff, including the thereof for the director, the scientific director, the scientific and the technical staff and the technical staff, and any staff, needed to fulfil the EU reference relevant sub-categories of staff if the laboratory tasks in the scope of candidate deems this necessary designation. 2 The candidate laboratories must have staff 2.1 Overview tables for knowledge and that fulfils the requirements referred to in experience of staff referred to in point 1.1 and document how those Annex III and the numbered requirements are fulfilled. supporting documents 3 The candidate laboratories must have a 3.1 Estimate of minimum capacity of the sufficient number of staff in relation to the candidate laboratory for task volume of the tasks they are to carry out. referred to in Article 100(2) (a) of Regulation (EU) 2017/746 (number of notified body requests processed 9  per year per device group referred to in Annex I, see template in Annex IV) 3.2 Estimate of minimum capacity of the candidate laboratory for task referred to in Article 100(2) (b) of Regulation (EU) 2017/746 (number of notified body requests processed per year per device group referred to in Annex I, see template in Annex IV) 3.3 Justification of the number of staff to cover the above capacities and the other tasks of EU reference laboratories referred to in Article 100(2) of Regulation (EU) 2017/746 4 The candidate laboratories must put in 4.1 Description of the continuous place a continuous training and education training and education programme programme for their staff. for staff 5 The candidate laboratories must possess 5.1 Justification as to which equipment the equipment, including specimens and and reference materials are control materials, and sufficient quantity necessary to carry out the tasks within the proposed scope of of reference materials, necessary to carry designation. The justification must out the tasks in the scope of designation of also cover specimens and control the EU reference laboratory. materials 5.2 Evidence that the candidate laboratory possesses the equipment referred to in point 5.1 and a sufficient quantity of the reference materials referred to in that point 5.3 A plan for the procurement of the specimens, control materials and reference materials referred to in point 5.1 6 The candidate laboratories must have up- 6.1 A list of international standards and to-date documentation on international best practices, including common standards and best practices that apply to specifications, that apply to the tasks the tasks within their proposed scope of within the proposed scope of designation. designation, and justification of their relevance 6.2 Evidence that the laboratory has integrated the international standards and best practices referred to in point 6.1 into the operating procedures for the relevant tasks 10  7 The candidate laboratories must identify at 7.1 Identification of the person having least one person within their management overall responsibility for the as having overall responsibility for the performance of the tasks set out in Article 100(2) of Regulation (EU) performance of the tasks set out in Article 2017/746 100(2) of Regulation (EU) 2017/746. 8 The candidate laboratories must have 8.1 Estimate of the expected volume of sufficient administrative staff to provide administrative work related to the the necessary administrative support for tasks referred to in Article 100(2) of Regulation (EU) 2017/746 performance of the tasks set out in Article 100(2) of Regulation (EU) 2017/746, in 8.2 Justification of the number of relation to the volume of those tasks. administrative staff to cover the volume of work referred to in point 8.1 9 The candidate laboratories must have an 9.1 Evidence of the laboratory’s status appropriate administrative organisation as a legal entity and structure. 9.2 If the laboratory is part of a larger organisation, a description of the activities of that organisation, its organisational structure and governance 9.3 If the laboratory is, directly or indirectly, controlled by other entities, the identity of such entities and their controlling position 9.4 A description of the laboratory’s internal organisational structure with clearly allocated responsibilities and reporting lines 9.5 A description of its operating procedures including management and performance of tasks, management of staff, a staff substitution plan, as well as registration of documentation and correspondence with external entities 9.6 Evidence of its sources of funding 9.7 Declaration that none of the exclusion situations referred to in Article 136 of Regulation (EU, Euratom) 2018/10466 apply to the 6 Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 11  candidate laboratory (template in Annex V) 9.8 Evidence of economic viability without financial assistance from the Union, including: 9.8.1 Economic viability template in Annex VI B 9.8.2 Balance sheets, profit and loss accounts or annual reports for the last three financial years 9.8.3 Where available, audits reports from the last three financial years 9.9 Proposed system for detailed records of the calculation of the costs and the corresponding fees levied (for the tasks that may be covered by fees) 10 The candidate laboratories must have a 10.1 Confidentiality policy including the confidentiality policy and put in place and following: document measures to ensure that the staff 10.1.1 the type of information that complies with the confidentiality policy. shall be considered confidential; 10.1.2 rules for the appropriate secure handling, storage and processing of confidential information and measures to prevent undue disclosure; 10.1.3 rules for sharing of confidential and non- confidential information with staff, and the public; 10.1.4 rules for granting access to confidential information to a competent authority of a Member State upon its request in the context of market surveillance or vigilance activities by the competent authority; 10.1.5 rules for sharing confidential information, on the initiative of the EU reference laboratory, with a competent authority of a Member State and with the 12  European Commission where the EU reference laboratory has reason to believe that such sharing is in the interest of protection of public health. 10.2 List of measures to ensure that the staff complies with the confidentiality policy 11 The candidate laboratories must have the 11.1 Confirmation by the Member State confirmation of their respective Member that the candidate laboratory will State that they will perform their tasks as perform its tasks as the EU reference EU reference laboratories in the public laboratory in the public interest and interest and in an independent manner in an independent manner within the within their proposed scopes of proposed scope of designation designation. (template in Annex XI) 12 The candidate laboratories must have a 12.1 Policy for the management of policy to ensure that the members of their conflict of interest of laboratory staff do not have financial or other interests staff, including steps to prevent, in the in vitro medical device industry, identify and resolve conflicts of which could affect their impartiality with interest regard to the performance of their tasks. 13 If designated, the candidate laboratory 13.1 A declaration as follows (template must not be the designer, manufacturer, in Annex VII): supplier, installer, purchaser, owner or 13.1.1 if designated, the candidate maintainer of devices within its scope of laboratory will not be the designation, nor the authorised designer, manufacturer, representative of any of those parties and supplier, installer, shall not be involved in the design, purchaser, owner or manufacture or construction, marketing, maintainer of devices within installation, use or maintenance of the the proposed scope of devices within its scope of designation. designation, nor the If designated, the candidate laboratory authorised representative of must not act as a notified body for devices any of those parties; within its scope of designation. 13.1.2 if designated, the candidate If designated, the candidate laboratory laboratory will not be must not perform any tasks related to involved in the design, conformity assessment under Regulation manufacture or (EU) 2017/746 on request by a notified construction, marketing, body, other than the tasks referred to in installation, use or Article 100(2) of Regulation (EU) maintenance of the devices 2017/746. within the proposed scope of designation; If designated, the candidate laboratory 13.1.3 if designated, the candidate must not enter into collaboration with a laboratory will not be a device manufacturer or a notified body notified body for devices concerning a joint commercial exploitation within the proposed scope of if such collaboration falls within its scope designation; of designation. 13  13.1.4 if designated, the candidate laboratory will not perform any tasks related to conformity assessment under Regulation (EU) 2017/746 on request of a notified body, other than the tasks referred to in Article 100(2) of Regulation (EU) 2017/746, within the scope of designation of the laboratory. 13.1.5 if designated, the candidate laboratory will not enter into collaboration with a device manufacturer or a notified body concerning a joint commercial exploitation, if such collaboration falls within the scope of its designation. 14 In case the candidate laboratory already If applicable: foresees outsourcing of testing to an external laboratory according to Article 7 14.1 A list of requirements set by the of the Commission Implementing candidate laboratory regarding the Regulation (EU) 2022/944. competence for fulfilling the tasks covered by the contract, including staff and equipment 14.2 Declaration by the candidate laboratory that the external laboratory: 14.2.1 satisfies the requirements in point 14.1 14.2.2 has in place and documents the measures referred to in point 10.2 regarding confidentiality policy; 14.2.3 confirms the absence of conflict of interest in accordance with the policy referred to in point 12.1 as regards the activities covered by the contract. 4 PREFERENCE CRITERIA These additional criteria are intended to allow evaluating the scientific excellence of the candidate laboratory. Up to 100 points may be awarded for the four criteria below. 14 Submission of the supporting documents for the preference criteria is not necessary at the initial application stage. Candidate laboratories that are required to prepare this additional documentation will be informed by their Member State at a later stage. The Annexes to be completed will be provided together with the notification. Means of proof Criterion 15 Team composition (exceptional level 15.1 Key scientific publications (up to of experience and knowledge relevant 10); references of research and other to the proposed scope of designation) – activities of proposed EU reference laboratory staff members, relevant up to 35 points for the proposed scope of designation and the tasks of an EU reference laboratory 15.2 A justification as to why these publications and activities show excellence of the candidate laboratory 16 Evidence of understanding of the 16.1 A simulation of a Work Programme mission as a EU reference laboratory of activities that could be undertaken and capacity to develop a work by the laboratory on its own initiative program as an EU reference laboratory (description of the activities, – up to 35 points objectives, expected outputs in line with Articles 100(2) and 100(5) of Regulation (EU) 2017/746) for three years (maximum ten pages, assuming a maximum budget of 200.000€ per year, template in Annex XII to be provided at a later stage in the application process if necessary) 17 International collaboration – up to 15 17.1 Evidence of activities at points international level relevant for the proposed scope of designation and the tasks of an EU reference laboratory, e.g. involvement and participation in international standardisation activities and networks (e.g. CEN, ISO), involvement and participation in other multinational activities (e.g. research projects), reliable and proven procedures for dispatching and receiving relevant materials from manufacturers, laboratories, hospitals situated in the EU & third countries (e.g. batches, samples, infectious material for diagnostic and research purposes) 15  18 Coordination – up to 15 points 18.1 Evidence of coordination activities e.g. organisation of conferences, workshops, training activities etc., close working relations with other laboratories in the same area of competence 5 SELECTION For each scope of designation, the applications selected will be the ones that comply with the selection criteria and, collectively, cover the estimated minimum EU-wide capacity as referred to in Annex I. In case of evaluation of the preference criteria, the applications selected will be the ones with the highest score. 16 Ref. Ares(2025)1258969 - 17/02/2025 Annex III Overview tables for knowledge and experience requirements of staff (point 2.1 of the selection criteria) This table can be prepared in Word or Excel format. Supporting documents such as CVs, university diplomas, certificates must be included with the application and assigned a reference number in the overview table. Director Name: Martin Dupont Position: Director Requirement Means of proof University degree : Certificate ref. no.12345 2 years of See CV ref. no.23456 professional experience: …1 Scientific staff Name: Clara Wittstock Karl Lehmann … Position: Scientific officer Scientific officer … Requirement Means of proof PhD in virology: Certificate ref. no.34567 … 2 years of See CV ref. no.45678 … professional experience: … Technical staff Name: Mario Rossi Laszlo Molnar … Position: Technician Technician … Requirement Means of proof University degree: Certificate ref. no.56789 2 years of See CV ref. no.67890 … professional experience: … 1 Add requirements from list of knowledge and experience requirements (selection criterion 1.1) Annex I X Application form for a consortium Nominating Member State 1: …………………………………………… ….. Competent authority 1: …………………………………………………………. Contact person regarding this application in Member State 1: Name: ……………………………………………………… Email:… ………………………………………………… Phone number:… ……………………………………….. If applicable : Nominating Member State 2: …………………………………………… ….. Competent authority 2: …………………………………………………………. Contact person regarding this application in Member State 2: Name: ……………………………………………………… Email:… ………………………………………………… Phone number:… ……………………………………….. Consortium member 1 Full name of consortium member 1 in English: …………………………………… ….. Full name of consortium member 1 in national language:… ………………………………………………………………………. Address of consortium member 1: ………………………………………………………. Consortium member 2 Full name of consortium member 2 in English: …………………………………… ….. Full name of consortium member 2 in national language:… ………………………………………………………………………. Address of consortium member 2: ………………………………………………………. Please fill in either Table 1 or Table 2 depending on the application wave. T able 1: P roposed scope of designation of the consortium as a whole , if applying as part of the first application wave : No Category Please tick 4 Detection or quantification of markers of arbovirus infection 7 Detection or quantification of markers of parasite infection 8 Detection of blood grouping markers Table 2 : P roposed scope of designation of the consortium as a whole , if applying as part of the second application wave : No Category Please tick 1 Detection or quantification of markers of hepatitis or retrovirus infection 2 Detection or quantification of markers of herpesvirus infection 3 Detection or quantification of markers of infection with bacterial agents 4 Detection or quantification of markers of arbovirus infection 5 Detection or quantification of markers of respiratory virus infection 6 Detection or quantification of markers of infection with haemorrhagic fever viruses or other biosafety level 4 viruses 7 Detection or quantification of markers of parasite infection 8 Detection of blood grouping markers Ref. Ares(2025)1258969 - 17/02/2025 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY The Director-General Brussels SANTE.DDG1.D.3/OT/ Subject: Call for applications for designation of EU reference laboratories in the field of in vitro diagnostic medical devices Your Excellency, I am pleased to inform you that, with this letter, the Directorate General for Health and Food Safety is formally launching a call for applications for designation of EU reference laboratories (EURLs) in the field of in vitro diagnostic medical devices, under Regulation (EU) 2017/746. The call will be run in two waves and covers various categories of devices of risk class D. I would be grateful if you could forward the attached documentation to all relevant authorities in your country. I would like to draw your attention to the fact that applications must be submitted by the Member States. Let me stress that the requirements in the call must be strictly complied with, including the deadlines for submission of applications. I look forward to the possible submission of applications for candidate EURLs by your country. Please contact the following e-mail addresses: [email protected]; SANTE- [email protected] for further information (subject: Call for applications for designation of EURLs). For technical assistance during the submission of applications, please send an email to: [email protected]. For background, this is the second call for EURLs under Regulation (EU) 2017/746. The first call was carried out in 2022, following which five EURLs were designated covering the following categories of class D devices: detection or quantification of markers of hepatitis and retroviruses, herpesviruses, bacterial agents and respiratory viruses that cause life-threatening diseases. More information can be found here: https://health.ec.europa.eu/medical-devices-vitro-diagnostics/eu-reference- laboratories-eurls_en Yours faithfully, Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111  Sandra GALLINA By email to: Permanent Representations of all EU Member States Missions of Norway, Iceland, Liechtenstein and Turkey to the EU Copy to: Members and observer countries of the Medical Device Coordination Group Enclosure: Call for applications for designation of EU reference laboratories in the field of in vitro diagnostic medical devices, with 12 annexes 2 Annex IV Template for estimated minimum capacity of the candidate laboratory for tasks referred to in points (a) and (b) of Article 100(2) of Regulation (EU) 2017/746 (points 3.1 and 3.2 of the selection criteria) Please indicate the e stimate d minimum capacity of the candidate laboratory for tasks referred to in points (a) and (b) of Article 100(2) of Regulation (EU) 2017/746 for one or more categories of devices which will constitute the proposed scope of designation. For applications submitted for a single laboratory : Please note that the candidate must cover all the groups within the category. Therefore all the individual group capacities within the selected category or categories must be filled in. For applications submitted for a consortium : Individual consortium members may cover some or all o f the groups within the category. The consortium as a whole must cover the entire selected category or categories. Note: Table 1 refers to the f irst a pplication w ave , while Table 2 refers to the s econd a pplication w ave . Please fill in one of tables as applicable. Table 1 : Categories and g roups a pplicable to the f irst a pplication wave and e stimated m inimum c apacity No Category or group Estimated minimum capacity of the candidate laboratory for tasks referred to in point (a) of Article 100(2) of Regulation (EU) 2017/746 (performance verification) Estimated minimum capacity of the candidate laboratory for tasks referred to in point (b) of Article 100(2) of Regulation (EU) 2017/746 (batch testing) 4 Detection or quantification of markers of arbovirus infection 4.1 West Nile virus 4.2 Dengue virus 4.3 Chikungunya virus 4.4 Zika virus 7 Detection or quantification of markers of parasite infection 7.1 Plasmodium spp. 7.2 Trypanosoma cruzi 7.3 Toxoplasma gondii 8 Detection of blood grouping markers 8.1 ABO system 8.2 Rhesus system 8.3 Kell system 8.4 Kidd system 8.5 Duffy system Notes or comments concerning the testing capacity of the candidate laboratory (e.g. indicate if the testing capacity can potentially be increased in the future , or other considerations on capacity estimates ). Table 2 : Categorie s and g roups a pplicable to the s econd a pplication wave and e stimated m inimum c apacity No Category or group Estimated minimum capacity of the candidate laboratory for tasks referred to in point (a) of Article 100(2) of Regulation (EU) 2017/746 (performance verification) Estimated minimum capacity of the candidate laboratory for tasks referred to in point (b) of Article 100(2) of Regulation (EU) 2017/746 (batch testing) 1 Detection or quantification of markers of hepatitis or retrovirus infection 1.1 Human immunodeficiency virus 1/2 Detection: Quantification: Detection: Quantification: 1.2 Hepatitis B virus Detection: Quantification: Detection: Quantification: 1.3 Hepatitis C virus Detection: Quantification: Detection: Quantification: 1.4 Hepatitis D virus Detection: Quantification: Detection: Quantification: 1.5 Hepatitis E virus Detection: Detection: 1.6 Human T-cell lymphotropic virus I/II Detection: Detection: 2 Detection or quantification of markers of herpesvirus infection 2.1 Cytomegalovirus 2.2 Epstein-Barr virus 3 Detection or quantification of markers of infection with bacterial agents 3.1 Treponema pallidum 4 Detection or quantification of markers of arbovirus infection 4.1 West Nile virus 4.2 Dengue virus 4.3 Chikungunya virus 4.4 Zika virus 5 Detection or quantification of markers of respiratory virus infection 5.1 Highly virulent influenza virus 5.2 Highly virulent coronavirus (SARS, MERS) 6 Detection or quantification of markers of infection with haemorrhagic fever viruses or other biosafety level 4 viruses 6.1 Ebola virus 6.2 Marburg virus 6.3 Lassa virus 6.4 Smallpox virus 6.5 Crimean-Congo haemorrhagic fever virus 7 Detection or quantification of markers of parasite infection 7.1 Plasmodium spp. 7.2 Trypanosoma cruzi 7.3 Toxoplasma gondii 8 Detection of blood grouping markers 8.1 ABO system 8.2 Rhesus system 8.3 Kell system 8.4 Kidd system 8.5 Duffy system Notes or comments concerning the testing capacity of the candidate laboratory (e.g. indicate if the testing capacity can potentially be increased in the future, or other considerations on capacity estimates). Annex XI Confirmation of the Member States regarding the performance of tasks in the public interest and in an independent manner (point 11.1 of the selection criteria) Nominating Member State :………………………….. Full name of the competent authority: …………………………. Full address of the competent authority: ………………………. I, the undersigned, [insert name] ……………………..……, [insert function of the undersigned in the competent authority] …………………………….., and thus legally authorised representative of the abovementioned competent authority vis-à-vis third parties and acting on behalf of that competent authority, in the context of the call for applications for designation of EU reference laboratories in the field of in vitro diagnostic medical devices according to Article 100 of Regulation (EU) 2017/746, confirm that the candidate laboratory mentioned below , if designated, will perform its tasks as an EURL in the public interest and in an independent manner: Full n ame of the candidate laboratory: …………………………. Full address of the candidate laboratory: ………………………. Full name: Date: Signature: Saatja: "Tiiu Noobel" <[email protected]> Saaja: "Ravimiamet" <[email protected]>, [email protected], "Maret Voore" Teema: FW: Call for applications for designation of EU reference laboratories in the field of in vitro diagnostic medical devices - Ares(2025)1258969 Kuupäev: 2025-02-18 10:55 Tähelepanu! Tegemist on välisvõrgust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. Tere! Edastan Komisjoni kirja, registreeritud EV AEEL juures 18.02.2025, nr 10.2-11/140. Parimate soovidega Tiiu Noobel Sekretär Eesti Vabariigi alaline esindus EL juures Rue Guimard 11/13, 1040 Brüssel Tel: + 32 2227 4337, <mailto:[email protected]> [email protected] <https://eu.mfa.ee/et/> https://eu.mfa.ee/et/ From: Esindus EL juures üldaadress <[email protected]> Sent: Tuesday, February 18, 2025 9:42 AM To: Tiiu Noobel <[email protected]> Subject: FW: Call for applications for designation of EU reference laboratories in the field of in vitro diagnostic medical devices - Ares(2025)1258969 From: [email protected] <mailto:[email protected]> <[email protected] <mailto:[email protected]> > Sent: Monday, February 17, 2025 7:39 PM To: Marten Kokk <[email protected] <mailto:[email protected]> > Cc: Esindus EL juures üldaadress <[email protected] <mailto:[email protected]> >; Agne Nettan-Sepp <[email protected] <mailto:[email protected]> >; Kadi Avingo <[email protected] <mailto:[email protected]> > Subject: Call for applications for designation of EU reference laboratories in the field of in vitro diagnostic medical devices - Ares(2025)1258969 Your Excellency, On behalf of Sandra Gallina, please find enclosed the formal launch of a call for applications for designation of EU reference laboratories in the field of in vitro diagnostic medical devices, under Regulation (EU) 2017/746 on in vitro diagnostic medical devices. Looking forward to the possible submission of applications for candidate EURLs by your country . Yours sincerely, SANTE Medical devices