«MANDATE AGREEMENTS» WITH AUTHORISED REPRESENTATIVES FOR MEDICAL DEVICES IN THE EU

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:

The subject-matters regulated by the agreements are, inherently, always of an international nature. Therefore, the particular framework of International Private Law must be taken into account.
According to the MDR, certain obligations of the manufacturers may not be delegated to the authorised representatives. Therefore, it must be ensured that the agreements do not contain any such delegation.
The particulars of the joint liability of representatives and manufacturers provided for by the MDR should be regulated in detail, as should be the procedure in cases of complaints regarding (allegedly) non-conforming, or faulty, devices.
The products covered by the agreement should be specified in detail. If necessary, several different agreements should be concluded.
In cases of non-compliance with the MDR, there may be considerable consequences for authorised representatives and manufacturers. The agreement should address the respective, individual responsibilities and liabilities.
It is to be expected that Swiss manufacturers will be granted, in the mid-term at the latest, preferential access to the EU market (again). This should be taken into account when regulating the term and termination of the agreement.
When addressing matters of data protection and dispute resolution, any applicable EU legal framework should be observed.
Matters of property of the medical devices concerned (including intellectual property) should be specifically addressed.
According to the MDR, authorised representatives must comply with certain requirements in oder to be permitted to perform their activities. The agreements should include explicit confirmations by the representatives that they actually comply with all relevant requirements as well as provisions addressing cases of non-compliance and/or inaccurate confirmations.

DRAFT AGREEMENTS

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.

BACKGROUND INFORMATION

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.