Serious Problems in EU-Switzerland Relations for Medical Devices

Until now, Switzerland has participated in the European Union’s internal market for medical devices through a specific chapter of the EU-Switzerland Mutual Recognition Agreement (MRA), developed with reference to Directive 93/42/EEC.

The medical devices chapter of the EU-Switzerland MRA provides for the recognition of conformity certificates, the elimination of double certification procedures, and the absence of an authorized representative. This ensures simplified access for Switzerland to the Union market and vice versa.

As stated in the document Notice to stakeholders: status of the EU-Switzerland Mutual Recognition Agreement (MRA), the principles on which the MRA is based are also at the center of the Institutional Framework Agreement under negotiation with Switzerland since 2014.
In this context, the EU has always made it clear that, in the absence of an agreement on the Institutional Framework Agreement, a complete update of the MRA cannot be considered. This update is fundamental for the agreement to still be considered valid, given the repeal of the Directive and the entry into force of the Medical Devices Regulation.

Therefore, from Wednesday, May 26, 2021, for medical devices falling under the new regulation (MDR), the benefits related to the MRA cease to apply.

Consequences for an EU Manufacturer

On May 19, 2021, the Swiss Federal Council integrated the Medical Devices Ordinance (MedDO) with the aim of mitigating the consequent negative effects and ensuring a sufficient supply of safe medical devices for the Swiss population.

Below are the main consequences for a manufacturer in the European Union intending to sell medical devices in Switzerland:

• CE marking certificates issued by notified bodies in Europe continue to be recognized. Therefore, it is not necessary to start a new certification process with a Swiss body. (Given the presence of clauses, it is recommended to obtain confirmation from your notified body).
• If the manufacturer is not based in Switzerland, their devices can only be placed on the market if they have designated an authorized representative based in Switzerland. The mandate must be agreed upon in writing. (Transitional provisions are in place).
• Within three months of first placing a device on the market, manufacturers or their authorized representatives and importers must register with Swissmedic. They will obtain a unique registration number (the equivalent of the Eudamed SRN). The requirement also applies to economic operators who placed medical devices on the market before May 26, 2021.
• The manufacturer must notify Swissmedic of serious incidents occurring in Switzerland and field safety corrective actions taken in Switzerland.

The above list is not to be considered exhaustive; it is important to analyze and define in detail the applicable requirements in each specific situation and context.

Consequences for a Swiss Manufacturer

The situation for Swiss manufacturers is decidedly more critical. Below are the main consequences for a Swiss manufacturer intending to sell medical devices in the European Union:

• For all new devices, Swiss manufacturers are treated like any other non-EU manufacturer intending to place their devices on the EU market. Devices must be certified by conformity assessment bodies established within the EU.
• Existing certificates issued under the MRA by conformity assessment bodies established in Switzerland are no longer recognized as valid in the EU.
• For existing certificates issued under the MRA by conformity assessment bodies established in the EU, Swiss manufacturers and third-country manufacturers whose authorized representative was previously established in Switzerland must designate an authorized representative established in the EU.

It is certainly important to emphasize that the last point therefore also impacts all non-EU manufacturers whose authorized representative was established in Switzerland.

The Role of Distributors and Importers

As is now well known, with the entry into force of the MDR, the role of distributors and importers has changed significantly. The two figures are active parts in the supply chain aimed at ensuring the marketing of compliant medical devices.
Therefore, it is also their duty to verify that the new provisions for placing devices on the market from Switzerland to the European Union and vice versa are respected. Blocking, if necessary, any non-compliant situations.

Whether it’s a Swiss manufacturer, European manufacturer, or distributor, importer, and authorized representative, it is recommended to rely on comprehensive and competent support in the field of medical device regulation.