What are the implications of the new Medical Devices Regulation (EU) 2017/745 (MDR) becoming applicable, for Switzerland?
Until 26 May 2021, Switzerland had been participating in the European Union (EU) internal market for medical devices through a specific chapter of the EU-Switzerland Mutual Recognition Agreement (MRA).
The medical devices chapter of the MRA provided for recognition of conformity assessment certificates between the EU and Switzerland based on equivalent regulations. This has facilitated seamless trade of medical devices between the parties.
On 26 May 2021, the new MDR became fully applicable, replacing the previous Medical Devices Directives 90/385/EEC and 93/42/EEC. On the same day, Swissmedic published new regulations applicable to medical devices.
In the relevant parts of the medical devices chapter of the MRA, an update concerning the new MDR is absent. This means that on On 26 May 2021, the mutual recognition and related trade facilitating effects for medical devices between the EU and Switzerland ceased to apply. Stakeholders were informed of this in a notice from the Commission.
About the Mutual Recognition Agreement (MRA)
The MRA is one of the key agreements between the EU and Switzerland facilitating bilateral trade in a number of key sectors. It is essentially a “single market access” and “dynamic alignment” with EU rules agreement, two principles which are at the core of the Institutional Framework Agreement in negotiation with Switzerland since 2014. This is the reason why the MRA falls under the scope of the EU-Switzerland Institutional Framework Agreement. This is fundamentally a level playing field issue.
The EU has always made it clear that in the absence of a deal on the Institutional Framework Agreement, an update of the MRA, including the medical devices chapter, cannot be considered.
On 30 March 2021, as a precautionary measure, the EU proposed to Switzerland, a limited modification of the medical devices chapter of the MRA providing for a transitional validity period for existing devices with Swiss certificates until 26 May 2024 (at the latest) and the same transitional validity for certificates issued in the EU. However, in spite of best efforts, the proposed modification was not agreed ahead of 26 May 2021.
As of 26 May 2021, what are the consequences for Swiss medical device manufacturers and certificates issues under the MRA by conformity assessment bodies established either in Switzerland or 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.
- For existing certificates issued under the MRA by conformity assessment bodies established in the EU, Swiss manufacturers and third country manufacturers whose authorised representative was previously established in Switzerland, must designate an authorised representative established in the EU.
- On 19 May 2021, the Swiss Federal Council adopted an amendment to the Swiss Ordinance on Medical Devices establishing conditions for trade of medical devices covered by EU issued certificates on the Swiss market. This includes the recognition of existing certificates issued under the MRA by conformity assessment bodies established in the EU and transitional timelines for the designation of a representative in Switzerland for EU/EEA manufacturers of medical devices.
What steps must affected stakeholders e.g. manufacturers take to address the above consequences?
In line with the Commission notice, to address the consequences above, stakeholders (e.g. affected manufacturers, EU importers and distributors, authorised representatives) as well as EU market surveillance and customs authorities in Member States are required to act in accordance with the Medical Devices Regulation (EU) 2017/745:
- Since existing certificates issued under the MRA by conformity assessment bodies established in Switzerland will no longer be recognised as valid in the EU as of 26 May 2021, to ensure that medical devices are certified by an EU conformity assessment body where such certification is required on the basis of the applicable conformity assessment procedure
- to ensure compliance with the requirements for economic operators, in particular the need for an EU authorised representative
- to comply with the requirements on registration and labelling of products.
Switzerland ends talks with the EU
On 27 May 2021, it was announced that Switzerland has ended its seven-year treaty talks with EU.
Any impact on the MRA will likely evolve over the coming weeks and months and be communicated by the responsible parties.
It should be noted that the medical devices chapter of the EU-Switzerland MRA also covers trade of in-vitro diagnostic medical devices, based on the Directive 98/79/EC and the corresponding Swiss legislation. This part of the chapter is supposed to continue to apply until the date of application of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746. Whether and how the end of the Swiss-EU talks has an impact on this remains to be established.