WHAT TO PAY PARTICULAR ATTENTION TO
When drafting «mandate agreements» between Swiss manufacturers of medical devices and authorised representatives in the EU, it should be refrained from using any kind of general «template». Equally, it is in no way sufficient to just copy and paste the minimum contents of such agreements provided for by the MDR. The complexity of the relevant subject-matters requires «tailor-made» documents in order to avoid severe and costly consequences in case there should be any difficulties during the cooperation. The following points in particular should be considered when drafting agreements between manufacturers and EU representatives:
should be drawn up, or at least reviewed, by legal professionals. We are at your disposal in order to provide any support needed in this respect.
Swiss manufacturers of medical devices currently benefit from a preferential access to the EU market. However, there are certain concerns that this access will cease to apply after the EU Medical Devices Regulation (MDR) will reach full applicability on 26 May 2021. As a consequence, many manufacturers prepare for having to comply, on that date at the latest, with the requirements any «third-country manufacturers» have to fulfill in order to be permitted to place their products on the EU market. The relevant requirements include, in particular, the designation of an «authorised representative» based in an EU member state. For such designations, in turn, the MDR provides for the conclusion of a «mandate agreement» between the (Swiss) manufacturer and the (EU) representative. Due to, inter alia, the particular complexity of the subject-matter concerned, the joint liability of manufacturers and authorised representatives provided for by the MDR, the inherently international nature of the business relation and the long terms of the agreements, drafting such agreements requires particular diligence.