On 24 May 2022, the European Commission published a notice to stakeholders on the status of the EU-Switzerland mutual recognition agreement (MRA) for IVDs.
- Until now, Switzerland has been participating in the European Union (EU) internal market for in vitro diagnostic medical devices (IVDs) through the medical devices chapter of the EU/Switzerland Mutual Recognition Agreement (MRA).
- The medical devices chapter of the MRA has provided for recognition of conformity assessment certificates between the EU and Switzerland based on equivalence of Directive 98/79/EC on IVDs and the corresponding Swiss legislation. This has facilitated seamless trade of in vitro diagnostic medical devices between the parties.
- The new Regulation (EU) 2017/746 on IVDs became applicable on 26 May 2022, replacing Directive 98/79/EC.
- In the absence of an update of the MRA to include Regulation (EU) 2017/746, the part of the MRA chapter covering IVDs ceased to apply as of 26 May 2022 (as clarified by the above notice). As a result, Switzerland will no longer participate in the EU internal market for IVDs and will be treated as a third country.
- As a result, the trade facilitating effects of the MRA for IVDs, including the mutual recognition of conformity assessment results, the absence of the need for an authorised representative and the alignment of technical regulations, cease to apply as of that date. Therefore, stakeholders should note the following consequences as of 26 May 2022:
- For all new IVDs, Swiss manufacturers will be treated as any other third country manufacturer intending to place its devices on the EU market. In particular, in vitro diagnostic medical devices of Swiss manufacturers requiring certification on the basis of a conformity assessment procedure must be certified by conformity assessment bodies established within the EU.
- Certificates issued under the MRA by conformity assessment bodies established in Switzerland will no longer be recognised as valid in the EU even if they were issued before 26 May 2022.
- For IVDs placed on the market after 26 May 2022, Swiss manufacturers and third country manufacturers whose authorised representative was previously established in Switzerland must designate an authorised representative established in the EU.
Accordingly, affected stakeholders (e.g. manufacturers, EU importers and distributors, authorised representatives) are required to act in accordance with the Regulation (EU) 2017/746 on in vitro diagnostic medical devices, noting in particular:
- the requirements for economic operators including the need to appoint an EU authorised representatives,
- the requirements on registration and labelling of products.
Further information/clarification is provided on the websites of the following agencies:
Source: Europa website