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EU Authorised Representative (EC REP) & Unannounced Audits

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 Notified Body, in accordance with the Commission Recommendation 2013/473/EU.

One leading UK Notified Body has issued a major non-conformity to a US based manufacturer due to their Dutch based EC REP not allowing for an unannounced audit as required under 2013/476/EU.

This meant that the Notified Body would not issue a CE certificate until this major non-conformity was closed out.

Advena have been aware of 2013/476/EU since it was published and were requested to help and take over the responsibilities as EC REP for this manufacturer. Of course, we were very happy to help.

It should therefore come as a great comfort to our clients and prospective clients alike that Advena are a professional organisation that takes its responsibilities seriously and with 20+ years’ regulatory experience, we have a wealth of knowledge which clients can tap into.

From this example of how Notified Bodies are assessing a manufacturer’s EC REP it should help make the decision process in appointing an EC REP much simpler.

By choosing Advena as your EC REP, you not only gain access to our regulatory experts, extensive experience and knowledgeable advice, you avoid this major non-conformity.

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