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. This makes the choice of appointing an EU REP significantly more challenging and important for the manufacturer.
An example of this happened recently, where the Dutch Competent Authority, Healthcare and Youth Care Inspectorate, Ministry of Health, Welfare and Sport, performed an audit on 24 Authorised Representative acting on behalf of more than three manufacturers. During their audit, they have found various deficiencies, these include:
- Using virtual offices/PO Box addresses – no employees at the EU REP address.
- PRRC without the necessary experience or qualifications.
- PRRC located outside the EU.
- Non-complaint with Article 11 of the MDR/VDR.
- Non-complaint with MDCG 2022-16
It is entirely possible that these non-compliances could lead to a major non-conformity for medical device and IVD manufacturers requiring them to find and appoint a new EU REP.
At least clients of Advena in Malta can rest easy in the knowledge that we are a founding member of the European Association of Authorised Representatives (EAAR) have over 25 years’ experience and meet all the necessary requirements to fulfil the role of an EU REP in accordance with EU legislation.
If you know of a manufacture who is looking to appoint an EU REP, please put a good word in for Advena and encourage them to reach out to us.
More information can be found using the following link
