Compliance Blog


Blog UDI facts 02-02-2021PNG

References

“Unique Device Identification (UDI) System – FAQs”, European Commission: https://ec.europa.eu/docsroom/documents/42641?locale=en

“Eudamed – requirements for all medical device manufacturers”, CEPK: https://cepk.dk/blog/eudamed-requirements-for-all-medical-device-manufacturers

Medical Device Regulation (EU) 2017/745, Official Journal of the European Union: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745

Blog Post Expert Panels MDRPNG

References

 “Commission guidance for the medical devices expert panels on the consistent interpretation of the decision criteria in the clinical evaluation consultation procedure”, Official Journal of the European Union: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=OJ:C:2020:259:FULL&from=EN

Medical Device Regulation (EU) 2017/745, Official Journal of the European Union: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745




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