Compliance Blog


Blog EUdamed and UDI factsPNG

References

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

“Fact sheet on MDR requirements for Transparency and Public information”, European Commission: https://ec.europa.eu/health/sites/health/files/md_newregulations/docs/transparency_factsheet_en.pdf

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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