Impact on the Authorized Representative by NEW medical device proposals
The new proposal on medical devices and the new proposal on in-vitro diagnostics medical devices as presented during the press conference of September 26th 2012, by the EU Commissioner for Health and Consumer Policy, John Dalli bring important changes to the role & responsibilities of the authorized representative.
Below is a review of some of the most important changes on the authorized representative, adopted by the European Commission under the new medical device proposals:
- In alignment with Decision 2010/227/EU, Authorized Representatives will be required to register themselves and the devices they place on the EU market in a central European database (Eudamed).
- For manufacturers not established in the EU, the authorized representative will be required to play a pivotal role in ensuring the compliance of such manufactured medical devices by serving as the official contact point in the European Union.
- Tasks/services should be clearly defined in a written mandate between the Non-EU manufacturer and his authorized representative in a way which will empower the latter to fulfill the said tasks/ services.
Article 9 point 39 of the proposal provides an excellent example to the above, requiring the manufacturer to provide his authorized representative with permanent & immediate (meaning: upon signature of the mandate) access to technical documentations.
- Manufacturers & authorized representatives will be required to make available within their organization at least one qualified person who possesses expert knowledge in the field of medical devices. This comes in alignment and in addition to the requirement within the MEDDEV 2.5/10, the European Commission Guidance document for Authorized Representatives
- The modalities to change an authorized representative as well as the transfer of tasks, responsibilities and technical documentation as well as the certitude of time frames for such proceedings between the outgoing and incoming authorized representatives shall be clearly defined in the written mandate.
- The obligations on EU importers & distributors to place medical devices on the EU market only when they are in conformity with the legislation and properly CE Marked, including the designation of an authorized representative, as well as ensuring continuous communication with the authorized representative in case they have reason to believe a device may pose a risk.
- The EU Declaration of conformity, issued by the manufacturer, to mention the name & address of the authorized representative.
- Certificates issued by Notified Bodies (e.g. ISO certificate, CE certificate or other conformity certificates), to mention the name & address of the authorized representative.