No mutual recognition agreement between the European Commission and Switzerland, what are the impacts for manufacturers?

One of the keys to facilitating bilateral trade between the EU and Switzerland is the Mutual Recognition Agreement (MRA). This agreement allows for the removal of technical barriers to trade in sectors regulated by the state, including the medical device sector. However, the agreement has not been signed between the two countries.

Background

Since 2001, regulation of medical devices between Switzerland and the EU has been equivalent and linked by the MRA to the European medical device market and surveillance system. However, this mutual recognition agreement ceased to apply as of May 26, 2021, notably following the entry into force in the European Union of the new Regulation (EU) 2017/745 on medical devices (MDR). Indeed, following the COVID-19 pandemic, the EU postponed the date of application of the MDR and, in parallel, Switzerland amended its legal bases to maintain equivalence. The agreed MRA also needs to be updated. But this update has not taken place and the Swiss Federal Council adopted new provisions in the Ordinance on Medical Devices (OMD) on May 19, 2021, which became applicable from May 26, 2021.

Access to the market and more generally, the trade of medical devices will no longer be as easy as before.

What are the impacts for Swiss manufacturers?

As a result, Swiss manufacturers will be treated as manufacturers from a third country intending to market their products in the EU and must take into account that:

• Medium and high-risk medical devices must be certified by a Notified Body established in the EU.
• Existing CE certificates issued under the MRA by a Notified Body established in Switzerland will no longer be recognized as valid by the EU.
• Existing CE certificates issued under the MRA by a Notified Body established in the EU for a Swiss manufacturer or a manufacturer from a third country with its representative established in Switzerland must designate a representative established in the EU.

What are the impacts for EU manufacturers?

Conversely, EU manufacturers must take into consideration the amendment to the Ordinance on Medical Devices that sets out the conditions for the trade of medical devices adopted by the Swiss Federal Council, which includes:

• The recognition of existing certificates under the MRA by a Notified Body established in the EU.
• Existing CE certificates issued under the MRA by a Notified Body established in Switzerland will no longer be recognized as valid by the EU following the amendment adopted by the Swiss Federal Council.
• Updating labelling to add Swiss representative contact details.
• Transition periods for designating a representative in Switzerland:
  • Until December 31, 2021: Class III medical devices, implantable Class IIb devices and active implantable medical devices.
  • Until March 31, 2022: Non-implantable Class IIb medical devices, Class IIa medical devices.
  • Until July 31, 2022: Class I medical devices

Due to this non-agreement between the two parties, manufacturers can now set up a system of representatives to sell their products and comply with these new obligations, in the hope that a new agreement will be established.

An authorized representative in Switzerland?

Following this ordinance, all foreign manufacturers must therefore have an authorized representative in order to sell their products on the Swiss market. An established agreement is required between the manufacturer and the authorized representative to conclude this relationship.

The role of the authorized representative is as follows:

• The authorized representative is a legal entity or a natural person
• The authorized representative has the same obligations as Article 11 of the MDR
• The authorized representative must have access to a copy of the manufacturer’s technical documentation or contractually agree that the manufacturer will transmit the documentation directly, on request, to Swissmedic. The authorized representative must ensure that this submission takes place within seven days.
• The authorized representative is responsible for the safety of the products with a central role in PMS and device monitoring
• The authorized representative is in contact with the Swiss authorities
• The authorized representative must have a PRRC (Person Responsible for Regulatory Compliance)
• The authorized representative is responsible for defective products
• The mandate holder must retain records for 10 years.

Is access to EUDAMED impossible?

In addition to the mandatory mandate system, the lack of agreement results in Swissmedic not being able to access the EUDAMED database. Economic operators (manufacturers, mandate holders, and importers) must therefore register with Swissmedic.

Economic operators are obliged to register with Swissmedic in order to obtain the unique identification number (Swiss Single Registration Number or CHRN) according to Article 55 of the ODim from May 26, 2021, and within three months of the first placing on the market of the device.

As for serious incidents and safety reports, they must also be reported and sent to Swissmedic.

Why choose to be accompanied by the Efor group?

Our quality and regulatory affairs experts will offer you high-quality support on all the following topics (non-exhaustive list):

• Assistance in finding your mandate holder
• Assistance with registration
• Assistance with updating product information

Feel free to contact us using the contact form