Germany recognises SQS certificates
On 26 May 2021, the EU Commission published information to stakeholders on the «Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for Medical Devices». Among other things, it 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 (see information dated 31 May 2021).
Swiss Medtech supports the position of the Federal Council, according to which the MRA is still valid and applicable. The position of the EU Commission therefore violates existing law (see information dated 9 July 2021). With regard to the SQS certificates, the association therefore initiated two actions:
- Swiss Medtech has provided a platform for the 54 Swiss manufacturers with SQS certificates to exchange information and join forces. Eight of the manufacturers concerned – represented by the law firm Sidley Austin LLP – filed a complaint with the General Court of the European Union on 8 December 2021.
- Swiss Medtech has attempted to influence the market surveillance authorities of other EU states via their national medtech associations. The aim was for individual EU states to oppose the EU Commission's ban on SQS. In Germany, these efforts have led to success: BVMed, together with BAH, BPI, MedicalMountains, Spectaris, VDDI and VDGH, had written to the AG MP (Working Group on Medical Devices of the Supreme State Health Authorities) on 9 July 2021. Their response arrived on 20 January: The 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.
We thank BVMed and our colleagues in the DACH region for their great support.