Are you Considering Selling your Medical Devices & IVD Devices in the European Union? Please remember that it is mandatory for medical device manufacturers located outside the EU to appoint an EU Authorised Representative. The EU REP plays a pivotal role in ensuring the compliance of devices produced by manufacturers who are located outside the … Read more
Authorised representatives are an essential link in the chain of ensuring safe and effective medical devices across the European Union. Under the MDR/IVDR, a change that may have escaped many peoples notice is EU REPs are now being supervised by and audited by EU competent authorities to ensure that they are performing their duties adequately. … Read more
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 … Read more
Notified Bodies seem to be placing greater scrutiny on medical device manufacturers who have appointed an EU Authorised Representative (EC REP) with particular reference to unannounced audits. As many of you may already know, Notified Bodies now consider the EC REP a critical subcontractor and are therefore subject to an unannounced audit by the manufacturer’s … Read more
This month we welcome Richard Bassett to our team at Advena Limited., as our newest Senior Regulatory Consultant and QMS expert. Some of you will already know Richard as he is joining us from a well-known major UK Notified Body where he has been a Client Manager and Lead Auditor. This has included working as … Read more
Over the years we have expanded our comprehensive European Authorised Representative services to many non-EU manufacturers who have traditionally used EU importers and distributors for this role. Now, and particularly with the new EU device regulations looming that require data sharing, perhaps the time may be now to ask the question; “Can you trust your … Read more
Manfred Koehler of the European Commission (in charge of European regulation for medical devices, SANCO Eurocrat and lawyer) joined the European Association of Authorised Representative (EAAR) on 26th September 2013. He went straight to the point that the European Commission consider the regulatory responsibility of Authorised Representatives (AR) for self-certified medical devices to be on … Read more
Advena Ltd
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Tower Business Centre
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BKR 4013. Malta
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