Tuttlingen – Switzerland was declared a third country on May 26th. With the termination of negotiations on an interinstitutional framework agreement between the EU Commission and Switzerland, all activities aimed at updating the mutual agreement (MRA), which is important for medical devices, in good time were discontinued. On May 26, 2021, the EU Commission published information that all existing certificates issued under the previous MRA by conformity assessment bodies based in Switzerland were no longer recognized as valid.
This step hit the medical technology industry abruptly, as no transitional periods were mentioned in the EU Commission's communication. The consequence: Certifications must be carried out by an EU conformity assessment body, EU authorized representatives must be appointed and all registration and labeling requirements according to EU MDR must be met.
According to the current state of knowledge, several German authorities in various federal states have already banned the import of Swiss products that have been certified by a federal notified body. This is illegal action – this is the conclusion reached by a legal opinion commissioned by Medtech Europe from the law firm Sidley Austin and available to MedicalMoutains GmbH. The memorandum contains, among other things, the following statements:
- The EU-wide sale of all MDD products with a valid certificate issued by a Swiss conformity assessment body before May 26th is still permitted.
- The EU and its member state authorities must grant Swiss medical devices access to the EU market under the same conditions as all other "legacy devices".
- The lifting of these obligations violates Article 120 of the EU MDR and the MRA
Accordingly, MedicalMountains GmbH is appealing to various state governments and authorities: The import restrictions should be lifted as soon as possible and Swiss certificates should continue to be recognised.
