Swiss MedTech published in the middle of May a document related the situation of Swiss manufacturers in light of the upcoming MDR. 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, although first steps initially were made to allow for the designation process of Notified Bodies to progress.
One of the consequences of failing to timely 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 MDD, and AIMDD, 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 a 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 EU Authorized Representative.
Practical Approach
Swiss manufacturers might need from 26th May 2021:
- Authorized Representative in place. If manufacturers have offices in European countries, these can be used as EU Authorized Representative. If no offices in other European countries, the manufacturer will have to use a third party for this role.
- Labeling needs to be adjusted.
- Contract for EU Authorized Representative needs to be in place.
- When the manufacturer makes use of a third party for EU Authorized Representative, it is important to start early searching and selecting the appropriate EU Authorized Representative. The reason is that under the MDR, the EU rep is jointly liable for defective products. That means the liability for EU Authorized Representative will change completely causing a shake out of authorized representatives under the MDR. The Authorized Representatives that remain will all have their own reviews, checks, and controls to deal with the liability. Therefore, manufacturers should expect a much more thorough review of their (technical) documentation. For manufacturers it is important to discuss and verify the requirements of the EU Authorized Representative before signing a contract. In the contract, the exact tasks of the EU Authorized Representative must be specified in a mandate.
Role of EU Authorized Representative
The EU 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 EU 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 EU Authorized Representative must be specified in a written mandate. This mandate is only valid if it is accepted in writing by the proxy. The EU 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 EU Authorized Representative becomes the primary contact person for the responsible authorities in the EU or EEA countries. The minimum duties of an EU Authorized Representative are set out in Article 11 of the MDR. They can be roughly divided into four fields:
1. 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.
2. Keeping available the Technical Documentation
3. Support of national authorities with preventive and corrective activities
4. Vigilance reporting
Please contact us, in case you are looking for an European Representative (MDR). Qserve offers the service of EU Authorized Representative under the MDR and IVDR. 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