Pending MRA of CH-EU

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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 mutual recognition agreement (MRA). In 2017 when the EU recast its regulatory framework for medical devices and published the new Medical Device Regulation (MDR) and in vitro Medical Device Regulation (IVDR), Switzerland revised its Medical Device Ordinance (MedDo) with the intention of aligning it with the EU MDR and IVDR. This approach would allow Switzerland to access the European internal market and joint surveillance between competent authorities while the MRA is being renewed.

As of 26 May 2021, the EU MDR has entered into force, but a necessary MRA between Switzerland and European Union is still pending. Without a valid MRA mutual access to – and trading of – medical devices, coordinated market surveillance activities and the sharing of information between authorities or the mutual recognition of certificates of conformity are affected. 

As a result, the Swiss competent authority- Swissmedic – has modified its already revised MedDo (version July 2020) and released the current version on 26 May 2021, the same applicable date and made the official announcement on its public website. The modified MedDo complements the revised MedDo and defines various measures and transitional periods designed to ensure the supply of safe medical devices in Switzerland and to offset the negative impact on market surveillance. These changes are

  • Switzerland allows unilateral market access to medical devices certified in the EU according to the MDR, thereby alleviates supply shortage in Switzerland;
  • Economic operators must register with Swissmedic and obtain a unique identification number (“Swiss Single Registration Number” CHRN) within three months of placing their first product on the Swiss market. The CHRN is comparable to the EU SRN (single registration number). Economic operators who have already placed products on the market before 26 May 2021, must complete the registrations by 26 November 2021;
  • Registration of medical devices on the Swiss market is also planned at a later date;
  • Vigilance reporting directly to Swissmedic due to denial access of Swissmedic and Swiss economic operators to EUDAMED;
  • Manufacturers outside Switzerland must appoint a Swiss authorised representative for all devices placed on the Swiss market after 26 May 2021, within the following deadlines:
    • for class III devices, class IIb implantable devices and active implantable medical devices: by December 31, 2021;

    • for Class IIb non-implantable devices and Class IIa devices: by March 31, 2022;

    • for class I devices and systems and procedure packs: until July 31, 2022.

  • Swiss manufacturers need to appoint an EU-Representative if their products are to be placed in the EU market.
These changes made to the currently valid MedDo, are administrative rather than technical in nature, but have far-reaching implications for Swiss and foreign manufacturers, authorized representatives and competent authorities in carrying out their business activities and managing market surveillance in both directions. Due to the unclear political outcome of the future negotiations between Switzerland and the European Commission and the relatively small market size of Switzerland, a large medical device organization might choose wait-and-see strategy instead of e.g. appoint a Swiss authorized representative and adjust all labelling information for their products in order to place products on Swiss market that could lead to supply issues for some medical devices on Swiss market; in contrast, the Swiss medical device manufacturers are heavily dependent on exporting to the EU market, and therefore need to appoint an EU authorised representative and change the labelling information of their products, which not only incurs additional costs but also adjusts supply chain. Manufacturers located outside the EU who have previously (until 26 May 2021) appointed a Swiss organization as their EU representative will have to appoint a new EU representative if they wish to continue selling in the EU. For all new devices, Swiss manufacturers will be treated as any other third country manufacturer intending to place their devices on the EU market. In particular, new Swiss medium and high-risk devices must be certified by conformity assessment bodies established within the EU. Existing certificates issued under the MRA by conformity assessment bodies established in Switzerland will no longer be recognised as valid in the EU (European Commission notice to stakeholders). This situation further complicates the challenge posed by the new MDR and IVDR. We need to closely monitor and follow up on the changes. 

4 thoughts on “Pending MRA of CH-EU”

  1. I‘m Vanessa from Chinese medical device company , I
    would like to know whether the grace period of registration is for MDD and MDR， since Class I products have come into force MDR , if I can’t appoint a swiss designated representative right now, can we place medical device on Swiss market？

    • Dear Vanessa
      Thanks for your message. Appointing a Swiss Authorised Representative (Swiss-Rep) is required by Swiss law as of the date of 26 May 2021. This requirement applies to all non-Swiss manufacturers regardless of risk class of medical devices, but different deadlines apply. For Class I device manufacturers, a Swiss Representative must be appointed before 31 July 2022. However, you might need to consider other regulatory obligations that arise from implementing Swiss-Rep requirement, such as registration of economic operator and etc. We offer Swiss-Rep service.

    • Thanks for your comments and we are pleased to hear that our sharing is beneficial to medical device peers. You can access more topics after registering as a free member.

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