As a result of the EU Commission's decision not to proceed any further with updating the Mutual Recognition Agreement with Switzerland (MRA) with effect from 26 May 2021, Switzerland no longer has access to the European single market for medical devices on an equal partnership basis but is since treated as a "third country".
Switzerland has therefore established measures under the revised Medical Devices Ordinance (MedDO), which came into force on 26 May 2021, to limit the negative consequences pending further negotiations with the EU. This means for manufacturers established outside Switzerland that additional requirements have to be fulfilled if they wish to continue making their medical devices available also on the Swiss market.
Particularly a Swiss representative (CH-REP) must be mandated to act on the manufacturer's behalf in relation to specified tasks in accordance with the MedDO. Manufacturers established in an EU/EEA member state or with a representative in an EU/EEA member state need to meet the following deadlines in this respect:
- for high-risk devices (Class III, IIb implantable and AIMD): 31 December 2021;
- for moderate-risk devices (non-implantable Class IIb, Class IIa): 31 March 2022;
- for low-risk devices (Class I): 31 July 2022;
- for systems and procedure packs: 31 July 2022.
In addition to the obligations for economic operators, the MedDO also contains provisions on the labeling of medical devices. The rationale behind this is to ensure fast and precise identification of all economic operators in order to enforce their obligations.
Accordingly, it is mandatory to indicate the name and address of the registered place of business of the manufacturer on the device itself or on its packaging. The name and address of the importer may also be indicated on a document accompanying the device. Regarding the information of the CH-REP, Swiss Medtech was able to achieve an agreement with the FOPH and Swissmedic on 17 December 2021. Going forward, this information does not have to be provided on the device or its packaging (or its instructions for use in case of medical devices under the old legislation), but as follows:
- for medical devices under the old legislation (i.e. a device that has been CE-marked under the former Directive 93/42/EEC or Directive 90/385/EEC) with an EU/EEA manufacturer or representative: on the device itself, its packaging, its instructions for use or in a document accompanying the device;
- for Class I medical devices under the new regulation: on the device itself, its packaging (or in a document accompanying the device until 31 July 2023);
- for Class IIa, IIb or III medical devices under the new regulation: on the device itself or its packaging.
This pragmatic solution helps to mitigate the issues faced by manufacturers, however, it still requires efforts from them, even though they are now slightly less cumbersome. Nevertheless, it may be advisable to indicate the CH-REP directly on the device itself or its packaging to avoid having to do so at a later stage.