Swiss MedTech suggests the appointment of EU EAR for Swiss manufacturers
At the moment, Swiss manufacturers have the same access to the EU market as EU manufacturers. This is based on the Mutual Recognition Agreement (MRA), as well as on the free trade agreements that enable the products to be freely traded between contracting parties.
If the unrestricted trading is to continue even after the MDR application date, which is 26 of May 2021, the MRA will have to be updated. If not, Swiss manufacturers will have to meet the requirements applicable to third countries in order to place their medical devices on the EU market.
Recently, Swiss MedTech issued a Guide inviting Swiss medical device manufacturers to appoint an European Authorized Representative before 26 May 2021, in order to minimize the risks related to export to the CE marking zone after the MDR date of application.
The Guide refers only to the medical devices that, at the moment, fall within the scope of MDD, AIMDD and the future MDR, thus excluding IVDs.
Appointment of the EU established EAR
One of the requirements that Swiss manufacturers might have to meet is appointing a European Authorized Representative. The EAR represents the manufacturer in the EU/EEA area and is responsible for a serious amount of tasks. Most notably, the EAR:
- Must be the primary contact for the Competent Authorities in the EU / EEA and must have access and keep the manufacturer’s documentation available;
- Must verify the respect of compliance (Declaration of Conformity, UDI-DI, EUDAMED,…);
- At the request of a Competent Authority, it must provide all the information and documents required to demonstrate the conformity of a product in the official EU language that the CA has specified in their request;
- Must forward any request from the Authorities to access the samples or test products to the manufacturer and verify if the access has been granted;
- Must immediately inform the manufacturer of incidents with the medical device.
Manufacturers may freely choose their EAR, and it can also be their importer or distributor. However, this is not recommendable, as their relationship is primarily commercial, so it may affect the obligations that they must undertake as EAR. The EAR’s tasks must be carried out independently of the remaining interests of the importer / distributor’s commercial agreement. The EAR mandate must be in writing and it must also be accepted by the EAR in writing. Upon request, a copy of it must be submitted to the Competent Authorities.
Appointing several EARs
All products that are placed on the EU market in accordance with the MDR, must have an EAR. A manufacturer can appoint different EARs for different products. However, it must be stipulated that one individual EAR must be responsible for at least all products in a generic product group.
The requirements that the natural or legal person must meet in order to be the EAR:
- To be able to rely upon a Person Responsible for Regulatory Compliance in the EU/EEA area in accordance with Article 15 of the MDR;
Both authorized representatives and manufacturers must have permanent access to the PRRC. However, as a general rule, manufacturers must employ a PRRC within their organization, while for the EAR it is sufficient to have access to the PRRC.
- To be a resident / established in the EU / EEA;
- Both the EAR and the manufacturer must register in EUDAMED and have a Single Registration Number (SRN).
Obligations of the manufacturer towards the EAR:
- The Manufacturer must provide all required documents without gaps to the EAR; this also includes confidential information, if they are required for notification or product testing;
- Labelling shall include the name and address of the EAR;
- Name, address and EAR’s SRN shall be included in the Declaration of Conformity and the name and address of the EAR shall be stated in the CE Certificate.
Change of the EAR
The MDR, namely Article 12 allows the EAR and manufacturer to regulate the provisions concerning the change of EARs in their agreements. However, the following points must be clarified in their agreement:
- Date of termination and re-acceptance of the mandate;
- Obligation of the previous EAR to continue forwarding all reports on incidents in connection with products he was responsible for to the manufacturer or the new EAR.
Regulatory Affairs department
If you are interested in changing your EAR to Obelis or if you are a Swiss manufacturer who wants to have an experienced EU-established EAR, contact us and we will send you our EAR Agreement today!Get in touch