The #EC has released a factsheet for manufacturers of implantable medical devices and related to the application of Article 18 of Regulation (EU) 2017/745.

Key Points:

-          Implantable devices will require an “Implant Card” IC, giving patients quick access to all relevant information for their device

-          Information includes:  Device Name, Type, UDI, Serial Number, Manufacturer Details, and patient details.

-          The Factsheet outlines other requirements, including IC size, use of symbols, language, etc.

🔗 https://ec.europa.eu/health/sites/default/files/md_topics-interest/docs/md_implany-cards_factsheet_en.pdf

#Implantable #MDRG #mdrguide #IVDR #MDR #medicaldevices #ec