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 par with the regulatory responsibility of Notified Bodies for higher class EC certified devices. He said ARs were to be an important partner to police non-compliance of non-EU manufacturers and to be part of the EU “intelligence system.”
He stated that the obligations and tasks for ARs will be spelled out more clearly in the near future and they will become the goalkeeper to keep the EU free from non-compliant Class 1 and other self-certified devices
He recommended that the trade association (EAAR) should have a clear code of conduct, including mechanism to alert Competent Authorities about non-complaint manufacturers, fraudulent CE marking and unlawfully operating ARs. It was pointed out that the Notified Bodies are under the spotlight now, with Authorised Representatives to follow.
The trade association asked the EU Commission to be clear as to how ARs should police the compliance of client’s CE documentation but he was not prepared to make any specific comment except by stating the requirement were already in law and the AR must have prompt access to clients (manufacturers) technical documents (and their regular updates) and they must be sure (how?) that such document were compliant.
He was also clear that an AR must cancel contracts, and report non-complaint manufacturers immediately. (In the same way Notified Bodies remove certificates from non-complaint higher class device manufacturers.)
He finally stated that ARs will need to work alongside importers and distributors to assure all traceability information was always available and that a “Qualified Person” always releases product onto the EU market. In this respect ARs should have access to distributor / importer identity,
Action by Advena Ltd is planned to keep up to date with these impending requirements;
- Assure that EU distribution contacts are part of the essential data to be available from clients. It may also be necessary to check if such distributors have suitable procedures to allow traceability.
- To have a procedure to follow for reporting non-complaint manufacturers and promptly cancelling agreements.
- Prepare to be audited and to be able to prove that we have access to all relevant documentation. (Netherlands already started)