Possible changes for the sale of Swiss MedTech products in the EU as of May 2020

Great news for Swiss Medtech companies – Postponement of the application date of MDR. Please have a look at the update.

The background in a nutshell

• Until 25th May 2020 all Medtech products that are admitted in Switzerland for the sale can be distributed also in the EU.
• However, currently a new treaty is negotiated by Switzerland and the EU Joint Committee in that regard.
• In case the treaty is not going to be concluded between Switzerland and the EU, all Medtech companies based in Switzerland are considered as not being anymore part of the EU. Indeed this treaty hangs by a hair.

Following the latest developments of the Swiss-EU negotiations concerning the Institutional Agreement and the Mutual Recognition Agreement (MRA), Swiss Medtech companies should be preparing for the case in which MRA would no longer apply to the medical devices after 26th May 2020.

What does it mean for Swiss established Medtech companies?

Implications for Medtech companies, in case the treaty is not going to be concluded:
Swiss established Medtech companies are not considered anymore as part of the EU, when placing their products in the EU. Therefore, for the distribution of the Medtech products the following three main requirements should be considered:

1. Appointment of a new EU representative
2. Appointment of a new importer of record (for regulatory purposes)
3. Amendment of the product labelling.

Furthermore,the new regulations define the implementation of a European centralised database by the regulatory authorities where all relevant data related to the sale of Medtech products have to be filed electronically.

This leads to an increased transparency – also for tax relevant data of the supply chain.

We would be happy to exchange with you about the latest developments as well as on the strategies/ tendencies we are observing at the market.