So to help we have extracted the two key Annexes on Classification and Safety and Performance Requirements (Replacement for the Essential Requirements) into two handy PDF documents.
Click the links below or here to download your copy.
- Medical Device General Safety and Performance Requirements (MDR Annex I)
- Medical Device Classification Rules (MDR Annex VIII)
Click here to download
If you really want the full, unexpurgated final texts: go here:
- European Medical Device Regulation (PDF / HTML Web page)
- European IVD Regulation (PDF / HTML Web page)
- Official journal for links to multiple language versions
What does it all mean? Read an overview of what’s changed in the new MDR.
Blog – Summary of changes
Seeking to understand the new MDR and the implications for European market access? Need to use your CE to leverage other markets? We are experienced in European compliance – from development of Technical Files, to preparation for CE audit, to local variations in other markets. Contact us for a no obligation discussion on how we can support your compliance and market access. Email firstname.lastname@example.org or call +61 2 9906 2984.