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Proposed amendment of IVDR transition periods
European Commission has proposed amendment of IVDR transition periods, latest until December 2029 to ensure patient care by availability of In Vitro Diagnostic healthcare products
The European Commission is proposing more time for companies to apply the In Vitro Diagnostic Medical Devices Regulation (IVDR), under certain conditions.
Class D --> new transition period until December 2027
Class C --> new transition period until December 2028
Class B/A* --> new transition period until December 2029
The proposal will now be forwarded to the European Parliament and Council for adoption.
See more details here.
KEY TAKEAWAY
Proposed Extension of IVDR Transition Periods
The European Commission is proposing extended IVDR transition periods to ensure continued availability of in vitro diagnostic healthcare products. Under the proposal, Class D devices have a new transition period until December 2027, Class C until December 2028, and Class B and sterile Class A until December 2029. The proposal will be forwarded to the European Parliament and Council for adoption.
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