Germany recognises SQS certificates
1 février 2022 – On 26 May 2021, the EU Commission informed on the «Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for Medical Devices» and stated that the EU would no longer recognise existing certificates issued by a notified body based in Switzerland – i.e. products with an SQS certificate. However, Germany disagreed with the EU Commission and on 20 January 2022, the German States (Bundesländer) decided that certificates of Swiss bodies notified under Directives 90/385/EEC and 93/42/EEC will continue to be valid until the deadlines set out in Article 120(2) MDR. Swiss manufacturers may therefore continue to sell their MDD products with SQS certificates in Germany, provided they have appointed an EC-REP for these products. According to the EU, however, the decision by the German authorities is not binding. Thus, the legal situation remains unclear.
For more information, see here (Swiss Medtech Portal), here (NZZ), here (Tagesanzeiger) and here (swissinfo).