MDR requirements blogPNG

References

Medical Device Regulation, article 29, 30, 31, 87, 120: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32017R0745&from=EN

“New enhanced reporting requirement is to strengthen the surveillance of medical devices”, Danish Medicines Agency: https://laegemiddelstyrelsen.dk/en/news/2020/new-enhanced-reporting-requirement-is-to-strengthen-the-surveillance-of-medical-devices/