Swiss Medical Device Laws to Align With New EU Regulations
Switzerland will transition its medical devices law in stages to align with the EU’s new regulations, with changes mirroring EU member states.The plan is part of efforts to ensure that Switzerland can continue to participate as an equal partner in the EU market for medical devices.
“Swissmedic, by collaborating with the competent authorities of the EU Member States, can continue its effective and efficient market supervision of medical devices,” the government notes, adding that for Swiss device manufacturers, access to the EU market will be maintained.
Details on Consultation
In October 2017, an early revision of Switzerland’s Medical Devices Ordinance (MedDO) was conducted to allow for Swiss conformity assessment bodies to register as designated bodies according to the new EU regulations as of 26 November 2017, and enabling Swissmedic to participate in the EU expert groups to be created.
The complete revision of the MedDO and a new ordinance for in vitro diagnostics will align with all provisions of the EU regulations and is scheduled to enter into force in the first half of 2020, the Swiss government said.
“Adjustments, in particular to the Therapeutic Products Act (TPA) and to the Human Research Act (HRA), aim to build a solid statutory basis for a complete overhaul of the MedDO as well as a new Ordinance for in vitro diagnostics,” the government said. “Entry into force of the legislative changes is scheduled for the first half of 2020. The consultation on the amendments [documents are only available in French, German and Italian] proposed by the Federal Council runs from 2 March to 11 June 2018.”
Consultation documentation for the revision of the Medical Devices Law (as of 2 March 2018)