The EU Commission issued a notification to stakeholders communicating that the Mutual Recognition Agreement (MRA) between EU and Switzerland was no longer recognized by EU as of from May 26
th, 2021. One consequence of this included that the EU would no longer recognize existing certificates issued under the MRA by notified bodies established in Switzerland as valid in the EU. Manufacturers were required to ensure that their medical devices were certified by an EU Notified Body (NB). Nevertheless, the Swiss Federal Council adopted an amendment to the Swiss Ordinance on Medical Devices on May 19
th, 2021 which recognises existing certificates issued under the MRA by EU notified bodies established in the EU.
On December 8th, 2021, several Swiss manufacturers with SQS certificates filed a complaint with the General Court of the European Union indicating that:
- The EU Commission’s decision to terminate application of the MRA and the withdrawal of the MRA for Swiss Legacy Devices are contrary to EU law, the MRA, and World Trade Organisation (WTO) law.
- Swiss Legacy Devices should be allowed on the EU market under the same conditions as all other Legacy Devices, and
- The EU and its Member States should continue allowing sales of all medical devices with a valid MDD certificate issued by a Swiss NB prior to May 26th, 2021.
As a result of this action, on January 20
th, 2022, the German AGMP (Working Group on Medical Devices of the Supreme State Health Authorities) communicated that certificated issued by Swiss NBs under Directives 90/385/EEC and 93/42/EEC will continue to be valid until the deadlines set out in Article 120(2) European MDR. This allows Swiss manufacturers with SQS certificates to continue selling their MDD products in Germany, provided they have appointed an EU Authorised Representative for those devices.