May 26th, 2021 has been the official day for the entry into force of the new regulation of medical devices (EU Regulation 2017/745, MDR).
The official entry into force of the MDR has also an important impact on the Mutual Recognition Agreement (MRA) between EU and Switzerland as concerns medical devices.
Till now with the “old” Medical Device Directive, the medical devices chapter of the MRA between EU and Switzerland provided for recognition of conformity assessment certificates between the European Union and Switzerland based on equivalent regulations.
This completely changes now, as the MRA has not been extended to the EU Regulation 2017/745. This means that Switzerland will be treated as any other third country. The immediate impacts are reported here below:
- Existing certificates issued under the MRA by conformity assessment bodies established in Switzerland will no longer be recognised as valid in the EU.
- For all the medical devices currently on the market, Swiss manufacturers and third country manufacturers whose authorised representative was previously established in Switzerland, must designate an authorised representative established in the EU
- New Swiss medium and high-risk devices must be certified by conformity assessment bodies established within the EU.
- On 19 May 2021, the Swiss Federal Council adopted an amendment to the Swiss Ordinance on Medical Devices establishing 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.
Additional details are reported in the communication issued by the European Commission:
https://ec.europa.eu/health/sites/default/files/md_dialogue/docs/mdcg_eu-switzerland_mra_en.pdf
Regulatory Pharma Net is available to provide additional insight and updates on the impact of the EU Regulation 2017/745 on the MRA between EU and Switzerland.