Placing medical devices on the market in Switzerland: All Requirements at a Glance | Update June 2022

The aim of the EU Medical Devices Regulation (EU-MDR) is to create a uniform basis for placing medical devices on the market in the EU. Brexit has already called for an additional level of regulation from medical device manufacturers and Switzerland is now also making market access more difficult. 

On May 26, 2021, when the EU-MDR came into force, the Mutual Recognition Agreement (MRA) was not extended, and the Medical Devices Ordinance (MepV) of July 1, 2020, created separate framework conditions for market access set up in Switzerland.

What are the effects of the regulatory requirements of the Swiss MepV?
With the end of the trade agreement (MRA not extended), the hurdle for placing medical devices on the market in Switzerland has increased significantly for manufacturers based in the European Economic Area, but it is not insurmountable. Anyone who carefully studies the MepV of July 1, 2020 with the latest valid version of May 26, 2022 will find a surprising number of references to corresponding articles of the EU MDR. Here it is important to transfer the content of the referenced article of the EU-MDR to the conditions of the Swiss target market and to link it to the requirements of the MepV. These regulatory requirements of the Swiss target market should be implemented accordingly in the QMS processes to be able to implement the requirements for the respective medical device in accordance with the Swiss requirements.

Good news!
Manufacturers, who place medical devices on the market under the EU-MDR have already largely implemented the resulting requirements of the MepV, since the EU-MDR is currently a much-cited reference in the MepV.
It is worth taking a closer look at the information on medical devices that manufacturers must provide. A gap analysis of the required labeling requirements in Switzerland is useful here in order to make products compliant with the Swiss market and to find out which processes in the QMS still need to be adjusted in order to map the regulatory requirements of the MepV.

The role of the new economic actor: the Swiss plenipotentiary
Under the MRA, the importer was sufficient as an economic operator to import the medical devices of a medical device manufacturer from the EEA into Switzerland and place them on the Swiss target market as a dealer himself or through other dealers. The MepV now requires a completely new role: the Swiss authorized representative (CH-REP). Like the EU representative (described in Art. 11 EU-MDR), this is the legal representative of the medical device manufacturer in Switzerland. When it comes to specific rights and obligations of the CH-REP and the requirements for the CH-REP, the MedDO also refers to the corresponding Art. 11 of the EU-MDR. In addition, the rights and obligations of the CH-REP must be agreed upon in writing and must be delegated to him by mandate.

What does that mean for a manufacturer of medical products in detail? 
In addition to the rights and obligations described in Art. 11 EU-MDR, special attention should be paid in the letter of appointment to how these rights and obligations are actually implemented. Clear regulations, which rights and obligations both the CH-REP and the manufacturer have to fulfill, form the foundation for a long-term, trusting cooperation between the economic players. In addition, clearly defined communication channels and deadlines should be coordinated and the processes implemented as to how to act in the event of a (serious) incident.

The CH-REP must be named by July 31, 2022 so that class I medical devices that are already on the Swiss market can continue to be placed on the Swiss market. This also means that the CH-REP should have access to the technical documentation of the manufacturer. The MepV offers manufacturers two options: either to provide the CH-REP with a copy of the technical documentation and the EU declaration of conformity, or as a manufacturer to transmit the documents to Swissmedic as the competent authority in the event of a (serious) incident, without the CH-REP having a copy of the technical documentation.

The notification of medical devices according to MepV: Where and how?
Like the obligation according to the EU-MDR to register the medical devices in the EUDAMED database, the MepV also speaks of a registration obligation for manufacturers. For the time being, there is still no obligation to register with Swissmedic for manufacturers of medical devices who are not based in Switzerland. It has not yet been clarified what the possible interface to EUDAMED might look like, whether there will be such an interface at all or whether the products will not also have to be registered with Swissmedic. Attentive readers of the MedDO will certainly remember Art. 17 Paragraph 5, which has not yet been formulated and has not come into force. This article, along with Art. 108 MepV, will in the future regulate the registration obligations of economic operators for the individual medical devices that they want to place on the Swiss market. When and how this will be implemented in the future is not yet known.

Do you want to place medical devices on the Swiss market? 
Clarify the following questions:
• Where is your quality management system currently and how far are you with implementing the regulatory requirements for access to the Swiss target market?
• Are your processes up to the regulatory requirements of the MepV and supplemented by them?
• Do you already have a designated CH-REP?
• Have you created a contractual basis for trusting cooperation with the letter of appointment for the CH-REP?
• Did you manage the balancing act of clearly defining all the regulatory requirements of the individual roles?
• And finally: Are you focusing on the regulatory requirements that are still changing?

The way to Switzerland
Placing medical devices on the market in Switzerland involves greater regulatory effort, but is not impossible. If you have clarified the above-mentioned questions for yourself, you are already on the right path. Qserve can help you out with the efficient regulatory route for the Swiss market. Please contact us with any questions.