New regulation to ease the renewal of the designation of NBs and prevent shortages of MDs in the EU

medical devices

New regulation to ease the renewal of the designation of NBs and prevent shortages of MDs in the EU

The European Commission (EC) has published a Commission Implementing Regulation to ease the renewal of the designation of notified bodies (NBs) and prevent shortages of medical devices (MDs) in the European Union (EU). This regulation will allow designating authorities to derogate from procedures described in Implementing Regulation (EU) No 920/2013.

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020R0666&from=ES

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Updated version of the document “EMA post-authorisation procedural advice for users of the centralised procedure”
Commission Implementing Decision C(2020) 2532