Swissmedic issues statement on becoming a ‘third country’

Swissmedic, the medtech competent authority in Switzerland, issued a statement on 26 May 2021, titled ‘Modification of the Medical Devices Ordinance (MedDO) in the context of pending agreements between Switzerland and the EU’, which read, in part:

“On 19 May 2021, the Federal Council approved supplementary provisions to the implementing regulations on medical devices. These enter into force on 26 May 2021, at the same time as the completely revised Medical Devices Ordinance (MedDO) and a new Ordinance on Clinical Trials with Medical Devices (CTO-MedD). In the context of aligning Swiss medical devices legislation to the new EU Medical Device Regulations MDR and IVDR, the MRA (Mutual Recognition Agreement) also needs to be updated so that barrier-free market access and joint surveillance can be ensured. However, the EU Commission is making the updating of the MRA subject to progress being made with the Institutional Agreement and is only prepared to negotiate on transitional provisions for medical devices covered by the old legislation.”

“Since 2001, Switzerland has regulated medical devices in the same way as the EU and has been integrated in the European market surveillance system and European internal market for medical devices via the MRA. To improve the quality and safety of medical devices – and hence also to increase patient safety – the EU has tightened the requirements for medical devices across Europe. Switzerland, too, has completely revised its medical devices legislation so that it closely approximates to the new EU provisions.”
“In parallel, the Switzerland-EU agreement on the mutual recognition of certificates of conformity (Mutual Recognition Agreement, MRA) also needs to be updated. It has not yet been possible to complete the updating of this agreement because it has been linked by the EU to progress made with the Institutional Agreement (InstA).”

“The supplementary provisions on the completely revised MedDO that were approved by the Federal Council on 19 May 2021 are designed to offset the negative consequences of the absence of the MRA update and ensure that the Swiss population is sufficiently supplied with safe medical devices.”

The end result is that in the absence of a medtech MRA between the parties, Swiss notified bodies are no longer allowed to issue certificates that are recognised by the EU, and Swiss manufacturers now have to designate authorised representatives within the EU 27. Although hopes for a medtech MRA, separate from InstA, have not been ruled out completely, significant disruption will already have been caused, which will undoubtedly take an equally significant effort to reset, should a new MRA become reality.

Meanwhile, the EU’s customs union with Turkey has now been renewed, so European manufacturers have free access to the Turkish medtech market, and vice versa, with Turkish notified bodies and authorised representatives continuing to be recognised by the EU for the MDR.