Various Options For Legacy Products Whose Conformity Assessment Certificates Have Expired
How does the European Commission’s proposal to amend the Medical Device Regulation to extend the transition periods for legacy devices impact devices that may seem lost to the market?
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18 January is the deadline to respond to the European Commission’s 6 January proposal to amend the Medical Device Regulation by extending legacy product transition deadlines. This article explains how changes are expected to be made.
The EU is looking at extending transition deadlines for compliance under the Medical Device Regulation as a matter of urgency. Now the European Commission is inviting feedback on its proposed measures.
The European Commission is now a step closer to implementing legislation that will see staggered delays for the application of the MDR in a bid to forestall medical devices shortages across the EU, with even longer extensions proposed than previously expected.