The MDR is a weighty tome – and with no contents list.
So we have created these Handy guides to the two most commonly referenced Annexes. Click below to download.
- Medical Device General Safety and Performance Requirements (MDR Annex I)
- Medical Device Classification Rules (MDR Annex VIII)
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 email@example.com or call +61 2 9906 2984.