Mutual Recognition Agreement Failed: Switzerland is a Third Country under the Medical Devices Regulation

The European Medical Devices Regulation (Regulation (EU) 2017/745 or MDR) has been in effect since May 26, 2021, and applies directly in all countries of the European Economic Area. All other countries are so-called third countries for which special, more extensive regulations apply when importing medical devices into the EEA.

However, the EU can also conclude so-called Institutional Agreements (InstA) with third countries and, among other things, agree on the mutual recognition of conformity assessment procedures (also called Mutual Recognition Agreement( MRA)). Yet, on May 27, 2021, it became known that the EU and Switzerland will not update the existing InstA (at least for the time being). It was known that the negotiations were difficult, but now the Swiss Federal Council has broken off the negotiations. The - still remaining - hope that Switzerland will not become a third country in the near future (as it used to be under the MDD) has thus finally been extinguished. As a result, Switzerland has lost its previously unhindered access to the European medical device market for a long time. Conversely, however, European manufacturers now also face hurdles when importing medical devices into Switzerland.

Result: For manufacturers from both areas (EEA and Switzerland), the regulatory hurdles have increased even further with regard to importing medical devices into the EU and Switzerland respectively.

Though Switzerland is now a third country and Swiss manufacturers therefore need an authorized representative and importer in particular, European manufacturers have to deal with Swiss regulations on the import of medical devices. While until now the Swiss market was freely accessible (and vice versa), European manufacturers now also require, for example, an authorized representative and importer in Switzerland. This results from the Swiss medical device law, the so-called MedV whereby it must be noted that amending decree to the MedV was issued on May 19, 2021: According to this, there are now, inter alia, certain transitional periods for manufacturers from the EEA - depending on the risk class of the medical devices - for the appointment of an authorized representative in Switzerland. In addition, the requirements for the provision of technical documentation ("TD") to the authorized representative have also been significantly reduced. In particular, the disclosure of the TD to the authorized representative is no longer mandatory, which also contributes to the protection of information.

Such a pragmatic approach, on the other hand, is sorely lacking in the MDR. No transition period applies here.