Other official publications

Other official publications

Harmonized Standards

Notified Body Operations Group (NBOG) Documents

NBOG’s documents are intended to provide guidance on specific aspects related to the activities of Notified Bodies.

NBOG Documents for medical device directives 90/385/EEC, 93/42/EEC and 98/79/EC
NBOG documents for Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR)

European Commission Consensus Statements

European Commission Interpretative Documents

Other documents


ISO 13485 Certified

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