Switzerland plans to extend the certification of medical devices to match changes in the EU and reduce the risk of supply disruption.
Recently, the EU changed the timeline for the transition to the Medical Device Regulation in response to a shortfall of notified body capacity that threatened to disrupt supply. Switzerland has aligned its medical device regulations with the EU since 2001 and while companies lost barrier-free access to the market in 2021, the country has continued to try to maintain equivalence with the rules in place (RELATED: Euro Roundup: Switzerland moves to mitigate split from EU on device regulation, Regulatory Focus, 03 June 2021).
The Swiss Federal Council intends to incorporate the EU changes by updating the Medical Devices Ordinance (MedDO) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO) in the autumn, according to a statement. Through the updates, Switzerland will maintain equivalence with the EU provisions and “reduce the potential impact on supply” in the country…
