Switzerland is already part way through transitioning to its own regulations due to the breakdown in its mutual recognition agreement with the EU at the end of May 2021.
The impact of the breakdown of the MRA is that Swiss manufacturers are now regarded as third-country companies in the EU. This means that Swiss manufacturers and those manufacturers who used Swiss notified bodies or authorized representatives must, therefore, have new certificates issued by EU notified bodies and have an authorized representative in an EU country.
In an update to the Swiss Medical Device Ordinance (MedDO), the Swiss equivalent of the EU Medical Device Regulation, published one week before the EU MDR was implemented on 26 May, three transition period deadlines were set for Swiss imports of CE-marked and labeled devices:
- 31 December 2021 for class III devices;
- 31 March 2022 for class II devices; and
- 31 July 2022 for class I devices.
After these dates, the continued export of devices into Switzerland by foreign manufacturers will be subject to their appointment of a local Swiss-based authorized representative (CH-REP), or use of their own local company in Switzerland, should they have one. This will necessitate product label changes.
Neither the UK nor Switzerland have access to, nor are part of, the Eudamed medical devices database.
QNET is in processing to open an local office in Switzerland to provide CH-REP services. Contact our office for more information.