Recent developments in the EU–Switzerland relations make it appear rather unlikely that the Agreement on Mutual Recognition of Conformity Assessments («MRA») will once again be amended before 26 May 2021. Given the fact that the regulatory framework for medical devices in the EU will change considerably on that date, this raised the question whether the MRA will cease to apply from 26 May 2021 on – either entirely or at least with regard to medical devices. However, our legal analysis of this issue has revealed that there are indications that the MRA as a whole as well as the chapter on medical devices contained in annex 1 to the MRA might remain applicable beyond that date. In particular, relevant provisions and principles of international law suggest that the MRA will not simply cease to apply to medical devices on 26 May 2021. Rather, it appears appropriate to assume that the MRA, or the relevant chapter of annex 1 on medical devices, would have to be formally declared terminated or suspended in order to lose their applicability. However, as far as a possible suspension is concerned, it appears rather doubtful that the applicable preconditions can be fulfilled (at least for the time being).
Therefore, if, for example, the EU should unilaterally take the view that the MRA ceases to apply to medical devices on 26 May 2021 and, consequently, should deny Swiss manufacturers of such devices the benefits of the MRA from that date on, there might be certain legal arguments that enable the manufacturers concerned to take action against specific measures affecting them. However, the relevant proceedings would be rather lengthy. Thus, manufacturers that might possibly be affected should consider taking precautionary measures in order to ensure that they continue to have uninterrupted access to the EU market after 26 May 2021. How such measures might be shaped, and what they would entail under specific circumstances, will be addressed in a separate publication.
The detailed legal analysis referred to above is available here (however, for the time being, in German only):