Esindajate nimetamine meditsiiniseadmete koordineerimisrühma, meditsiiniseadmete komiteesse ja vastutava pädeva asutuse nimetamine vastavalt meditsiiniseadmete määrustele

ANNEX 7  AUTHORITIES RESPONSIBLE FOR THE IMPLEMENTATION OF MDR / IVDR Member State / Country: Estonia notifies, in accordance with Article 101 of Regulation (EU) 2017/745 on medical dcvices and Article 96 ofRegulation (EU) 20 17/746 on in vitro diagnostic medical devices, the following authority(ies)’ responsible for the impiementation of the Regulations with the effect of 1 January 2025: Field of competence: Medical devices Narne of the authority: State Agency of Medicines Contact details, including postal address and e-mail: Medical Deviccs Department, State Agency ofMedicines Nooruse 1, Tartu, Estonia, 50411 +372 737 4140 [email protected] On behalf of the notifying authority: [signature ofa person authorised to make the notification to the Commission, in accordance i’ith any applicable national / internal proceduresJ Signature: Name: Affihiation: Ministry of Social Affairs of Estonia Date: 19.11.2024 If more than one authority is responsible for impiementation of MDR / IVDR, the table should be copied and fihled out accordingly, indicating each time the relevant field of cornpctencc. ANNEX 2  MEDICAL DEVICE COORDINATION GROUP (MDCC) NOTIFICATION BY EU MEMBER STATE OF APPOINTED MEMBERS AND ALTERNATES Member State: Estonia hereby notifies the following experts to the MDCG, appointed in accordance with Article 103(2) of Regulation (EU) 2017/745 on medical devices, with the effect of 1 January 2025: (i) in the capacity ofa member with expertise in the field of medical devices’: First name and surname: PIRET PÖIKLIK Name of the authority ofaffihiation: State Agency of Medicines Contact details, including postal address and e-mail: Medical Devices Department, State Agency ofMedicines Nooruse 1, Tartu, Estonia, 50411 +372 737 4140 [email protected] (ii) in the capacity ofan alternate with expertise in the field of medical devices2: First name and surname: KRISTINA KUBAR Name of the authority ofaffihiation: If the same person has been also appointed as a rnember with expertise in the field of in-vitro medical devices, then the name ofthat person should be repeated in point (iii) below. 2 If the sarne person has been also appointed as an alternate with expertise in the ficld of in-vitio medical devices, then the name ofthat person should be repeated in point (iv) bclow.  State Agency of N’Iedicines Contact details, including postal address and c-mail: Medical Devices Department, State Agency of Medicines Nooruse 1, Tartu, Estonia, 50411 +372 737 4140 [email protected] (iii) in the capacity of a member with expertise in the field of iii vitro diagnostic medical devices: First name and surname: PIRET PÖIKLIK Name of the authority ofaffihiation: State Agency of Medicines Contact details, including postal addrcss and e-mail: Medical Devices Department, State Agency ofMedicines Nooruse 1, Tartu, Estonia, 50411 +372 737 4140 [email protected] 2 (iv) in the capacity of an alternate with expertise in the field of iii vitro dia2nostic medical devices: First name and surnarne: EGLE AUDOVA Name of the authority ofaffiliation: State Agency of Medicines Contact details, including postal address and e-mail: Medical Devices Department, State Agency ofMedicines Nooruse 1, Tartu, Estonia, 50411 +372 737 4140 [email protected] On behalf of the notifying authority: [signature ofa person authorised to make the notijication to the Comrnission, in accordance with any applicable national / internal proceduresJ 77 Signature: /Anniki Lai Name: / Affihiation: Ministry of Social Affairs ofEstonia Date: 19.11.2024 3 REPUBLIC OF ESTDNIA MIN ISTRY OF S0cIAL AFFAIRS Estelle Goeger European Commission DG for Internal Market, Industry, Entrepreneurship and SMEs Our ref. 19.11.2024 No 1.4-2/2928-1 [email protected] Avenue d’Auderghem 45 B-1049 Brussels, Beigium Governance of the Medical Device Regulations Dear Ms Goeger In continuation of the nomination letter sent out on 15 September 2017, please find attached renewed nomination Ietters from the Ministry of Social Affairs of Estonia. Yours sincerely, nniki Lai Deputy Secretary General on Health Encl. nomination letters (Annex 2, Annex 5, Annex 7) Tiina Rootamm +37253675311 [email protected] Suur-Ameerika 1/10122 Tallinn / ESTONIA/ +372 626 9301 / [email protected] / www.sm.ee / Reg. no 70001952 ANNEX 5  COMMITTEE ON MEDICAL DEVICES (comitology committee) NOTIFICATION OF DESIGNATED REPRESENTATIVES Member State / Country’: Estonia hereby notifies the following representative(s)2 to the Committee on Medical Devices, established by Article 114(1) of Regulation (EU) 20 17/745 on rnedical devices, in connection with Article 107(1) of Regulation (EU) 2017/746 on in vitro diagnostic medical devices with the effect of 1 January 2025: First narne and surname: PIRET PÖIKLIK Name of the authority of affihiation: State Agency of Medicines Contact details, including postal address and e-mail: Medical Devices Department, State Agency of Medicines Nooruse 1, Tartu, Estonia, 50411 +372 737 4140 [email protected] On behalf of the notifying authority: [signature ofa person authorised to make the notification to the Comrnission, in accordance with any applicable national / internalprocedures] Signature: Name: %ki Lai Affiliation: Ministry of Social Affairs of Estonia Date: 19.11.2024 Participation in the cornitology committee of a non-EU country is deterrnined by the rules of any relevant agreelnent in place between the EU and that Country, and the designation ofrepresentatives to the Comrnittee on Medical Devices is without prejudice to those rules. 2 If inore than one representative is notified, the table should be copied and flhled out accordingly. Appointment of one or more representatives does not affeCt the voting rules in accordance with Regulation (EU)No 182/2011.