Swiss manufacturers of medical devices have so far been able to participate without restrictions on the EU internal market. This is ensured for products that are in Conformity to the two directives MDD, 93/42 EWG; and AIMDD, 90/385 / EWG. Base for this status is a Mutual Recognition Agreement between the Swiss Confederation and the European Union on performed assessments.
There are indications that the Mutual Recognition Agreement between the Swiss Confederation and the European Union will not be updated related to applicability to Regulation (EU) 2017/745.
One of the consequences of failing to update the agreement is that Swiss manufacturers from the beginning of applicability of the MDR would have to meet third country requirements for devices falling under Regulation (EU) 2017/745. This includes medical devices which are certified under Directive MDD, 93/42 EWG; and AIMDD, 90/385 / EWG, but take benefit from the “soft transition period” of the MDR until latest 26 May 2024, since these devices formally fall under the scope of the MDR from date of application on.
This means Swiss manufacturers must appoint an European European Authorized Representative in the EU or EEA and they have to adjust the labeling of their products accordingly to reflect name and address of the European European Authorized Representative.
The European European Authorized Representative represents the manufacturer in the EU and takes over certain manufacturer responsibilities and risks. To do this, he must also have access to the current Technical Documentation at all times. The European European Authorized Representative can be freely chosen, but needs to fulfill certain conditions regarding regulatory know-how and has to be located in the EU / EEA area.
The exact tasks of the European European Authorized Representative must be specified in a written mandate. This mandate is only valid if it is accepted in writing by the proxy. The European Authorized Representative is also obliged to hand over a copy of the mandate contract to the competent authority (e.g. BfArM in Germany) on request.
The European Authorized Representative becomes the primary contact person for the responsible authorities in the EU or EEA countries. The minimum duties of an European Authorized Representative are set out in Article 11 of the MDR. They can be roughly divided into four fields:
- Verification of compliance with the registration regulations
- check that EU declaration of conformity and Technical Documentation are available
- check if a corresponding conformity assessment procedure has been carried out
- check that manufacturers and importers have correctly registered
- check that products have been assigned the correct UDI-DI and have been entered into EUDAMED
Verification activities must be adequately documented
- Keeping available the Technical Documentation
- Support of national authorities with preventive and corrective activity
- Vigilance reporting
Both the manufacturers and the European Authorized Representatives must have access to a responsible person. According to MDCG 2019-7, the responsible person of the European Authorized Representative must be located in the EU.
Liability of the European Authorized Representative
If the manufacturer is not established in a Member State and has not fulfilled its obligations under Article 10, the European Authorized Representative shall be legally liable for defective products, without prejudice to paragraph 4 of this article, on the same basis as the manufacturer, with the latter as joint and several debtor.
Qserve offers the service of European Representative. Our service package includes the following elements:
- Use of name and registered address within the EU on all product related labelling.
- Official appointed contact address for European regulatory agencies.
- Assistance in communication between the competent authority and the manufacturer.
- Thorough review of your EU declaration of conformity and Technical Documentation.
- Preparation and registration of the initial product in the electronic system.
- Update listing of product registration in the electronic system.
- Assistance and coordination of complaint handling and incident reporting to the Competent Authorities.
- Updates regarding regulatory changes which might impact devices and registrations
- Advice on registration strategies
Please contact us, in case you are looking for an European Representative.