Position Paper: Article 117 Substantial Changes for Drug-Device Combinations

Position Paper Team NB 2021-12-21
Home/ Resources/ Position Paper: Article 117 Substantial…

Summary

Team NB position paper providing guidance and clarification for Notified Bodies on EU MDR/IVDR compliance.

Document Type: Position Paper

Source: Team NB (Team of Notified Bodies)

Download PDF →

Document Details

TypePosition Paper
AuthorityTeam NB
Publication Date2021-12-21

Download Document

Download PDF

Quick Info

TypePosition Paper
Published ByTeam NB
Date2021-12-21

Regulatory Support

Need help understanding this guidance document?

Contact Us
Scroll to Top