January 20th, 2020, Switzerland’s MedTech industry association (Swiss MedTech) issued an information letter addressed to all Swiss manufacturers of medical devices. In this letter Swiss MedTech warns that third country compliance for all products (MDR and MDD) from 26 May 2020 is currently the realistic worst-case scenario.
An update of the Mutual Recognition Agreement (MRA) is required to ensure barrier-free access to the EU single market for products placed on the market in accordance with the MDR 2017/745. However, according to the letter issued by Swiss MedTech the EU Commission lawyers have been interpreting the MRA in the most unfavourable way possible for Switzerland and their position assumes that the MRA will no longer apply to medical devices after 26 May 2020. Hence, from Swiss MedTech’s perspective today, the worst-case scenario of Swiss manufacturers having to meet third country requirements for all medical devices (MDR and MDD) from 26 May 2020, is the realistic scenario.
Complying with third-country requirements in order to legally place products on the EU market in accordance with the MDR 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.
Please note that a last-minute political solution is still possible. It is thus up to each company to decide whether or not to prepare to meet the third-country requirements.
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. Whatever you decide, keep in mind that MDR fully applies as of May 26th, 2020, a mere 4 months 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.