This document is long overdue, however, here it is! The MDCG 2022-16 Guidance on Authorised Representatives concerning Regulations (EU) 2017/745 & 2017/746. It lays out what medical device manufacturers should expect as a minimum from their appointment EU Authorised Representative. There are some interesting elements of the Regulations explained and clarified as guidance and as always these documents have elements that contradict or provide no clarification.
For a copy of this guidance document please follow this link: [MDCG 2022-16]
Please do remember this document is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission. Any views expressed in this document are not legally binding and only the Court of Justice of the European Union can give binding interpretations of Union law. But we’ll see how this works in practice!
One thing is for sure, and that is medical device manufacturers must ensure that they take the time to appoint knowledgeable and experienced representation and should look to appoint an EU Authorised Representative with the necessary skills and experience, and dare we say one such as Advena Limited a founding member of the EAAR (European Association of Authorised Representatives).
Email Advena now for a free quotation: info@advena.mt
