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Saatja: [email protected] Saaja: [email protected], [email protected] Teema: Survey from ANSM on media used in cornea process preparation Kuupäev: 2023-12-12 09:53 Dear Competent Authorities for Tissues and Cells, Please find below a message from the French Agence nationale de sécurité du médicament et des produits de santé (ANSM) regarding media used in cornea process preparation. In France, we currently have an issue related to media used in cornea process preparation. The majority of the tissue establishments used media manufactured by Eurobio (Cornea Prep, Cornea Max, Cornea Jet). However Eurobio has not yet obtained a CE label and is facing some difficulties because of unavailability of an antibiotic. Eurobio needs to change supplier for these antibiotics and needs to amend their CE application, which will delay and may compromise the CE labelling. In this context some tissue establishments have changed the media used in cornea process preparation from Eurobio to Alchimia (Tissue C, Carry C). These media are CE marked but a new CE application will be submitted under the new medical device regulation. It would be very helpful for us to understand how the situation is delt in the other National Competent Authorities. To this end, we have prepared a survey containing 5 questions. Here is the link to the survey: <https://ec.europa.eu/eusurvey/runner/CorneaMedia_dec2023> https://ec.europa.eu/eusurvey/runner/CorneaMedia_dec2023 We would be very grateful if you would kindly answer it before the 12th January 2024. Should you have any question, please contact ANSM directly at the following email address: Laure DELIGNIVILLE [email protected] <mailto:[email protected]> . Best regards, The SoHO team. European Commission DG SANTE (Health and Food Safety) Unit B4 – Medical Products: quality, safety, innovation Office address: Rue Breydel 2, 06/004, B-1049 Brussels/Belgium http://ec.europa.eu/health/blood_tissues_organs/policy/index_en.htm