UK And Swiss Notified Bodies Announce Bad News For Clients
The UK is about to lose most of its medtech notified body offering, as its remaining notified bodies reveal plans to migrate certificates to the EU27 in a rescue bid, given the impact of a potential no-deal Brexit. In Switzerland, too, there has been bad news for notified body clients.
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With finite resources, the UK’s regulatory agency responsible for health care products is rapidly addressing COVID-19 medtech issues. But shifting its focus will cause delays elsewhere.
Non-CE-marked products on the EU market, virtual notified body audits, free standards and the Commission bid to pause the MDR. March has seen unprecedented developments as COVID-19 has railroaded through the sector decimating regulatory rules and plans.
Suppliers to the UK’s National Health Service from outside the EU could save up to 12% in costs for some equipment during COVID-19 emergency measures as the UK tries to increase supplies