Medical device CE marking

Commission publishes information on the status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices

2022-05

Until now, Switzerland has been participating in the European Union internal market for in vitro diagnostic medical devices through the medical devices chapter of the EU-Switzerland Mutual Recognition Agreement (MRA). The medical devices chapter of the MRA has provided for recognition of conformity assessment certificates between the European Union and Switzerland based on equivalence of Directive 98/79/EC on in vitro diagnostic medical devices and the corresponding Swiss legislation. This has facilitated seamless trade of in vitro diagnostic medical devices between the parties.

The new Regulation (EU) 2017/746 on in vitro diagnostic medical devices has become applicable on 26 May 2022, replacing Directive 98/79/EC. In the absence of an update of the MRA to include Regulation (EU) 2017/746, the part of the MRA chapter covering in vitro diagnostic medical devices ceases to apply as of 26 May 2022.

As a result, the trade facilitating effects of the MRA for in vitro diagnostic medical devices, including the mutual recognition of conformity assessment results, the absence of the need for an authorized representative and the alignment of technical regulations, cease to apply as of that date.

The document can be downloaded from our library

Source: European Commission