TEAM-NB is the European Association of Notified Bodies for Medical devices. It is a non-profit organization which its members are Notified Bodies (EU bodies accredited to certify for CE Marking). It has published on November 7th 2012, a position paper titled “How and whether to audit Authorized Representatives”?
The role of the European Authorized Representative has been given a serious upgrade ,during 2012, by the MEDDEV 2.5/10 “Guideline for Authorized Representatives” and even more so by the new proposals for medical device regulations, 2012.541 & 2012.542, adopted on September 26th 2012, by the EU Commission. This upgrade requires all involved to equally upgrade their respective conformity procedures and adapt to the changes and those to come. This position paper by TEAM-NB provides an initial draft for such an upgrade by Notified Bodies for the medical device directives, MDD 93/42/EEC, AIMDD 90/385/EEC and IVDD 98/79/EC.
The Position Paper will aim to create a Notified Body consensus on a list of the minimum to assess when auditing a Manufacturer outside Europe regarding the agreement with his Authorized Representative (AR).
Items such as the below are expected to be essential within the list to be:
- Manufacturer should have identify an AR;
- There should be a single AR for each medical device;
- A final agreement should exist;
- The agreement should follow the MEDDEV;
- There should be a signed agreement before the EC declaration of conformity is signed;
- If the Manufacturer outsourced vigilance or other processes to the AR, there should be need Standard Operating Procedures and possibly an audit;
- NB should be notified in case of change of AR.
The enforcement of a proper, mutually signed agreement between the Non-EU manufacturer and his Authorized Representative in Europe, prior to obtaining the CE marking and taking into account all up to date requirements will rapidly grow. This will strengthen the need for a professional European Authorized Representative present at all times.
Need more information? Contact us now!