Swiss MedTech Recommendation

April 25th, 2019 Switzerland’s MedTech industry association (Swiss MedTech) issued a recommendation to all its members, urging them to prepare to meet third-country requirements when it comes to marketing products in the EU under the EU Medical Device Regulation (MDR 2017/745).

An update of the Mutual Recognition Agreement (MRA) will be required to ensure barrier-free access to the EU single market for products placed on the market in accordance with the MDR 2017/745. Because an update to the MRA is not assured at this point in time, Swiss MedTech recommends all manufacturers, with registered place of business in Switzerland, to include in their business considerations that they may have to comply with third-country requirements to place products on the EU market in accordance with the MDR.

This would entail:

  • appointing an authorised representative with a registered place of business in the EU area;
  • supplementing the product labelling with the authorised representative and importer.

The recommendation states that it is possible that the Federal Council will voice its support for the Institutional Agreement, which is the prerequisite for updating the MRA, in time. It is thus up to each company to decide whether or not to prepare to meet the third-country requirements now or to wait for more information.

The recommendation also informs Swiss companies of other aspects that could influence the transitional provision of the MDR. Exemptions to the MDR might apply if Brexit leads to a Europe-wide supply bottleneck, or due to insufficient certification capacity by notified bodies.

What does this mean to you?

If you are a manufacturer with a registered place of business in Switzerland, you should make a business decision to either prepare to comply with third-party requirements or to take the risk and wait for more information. Whatever you decide, keep in mind that MDR fully applies as of May 26th, 2020, this means roughly one more year from now. Setting up an agreement with an EU Authorised rep, redesigning all labelling and establishing a cutover plan can take several months to complete.

Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.