European Parliament Agrees to Give IVD Firms More Time to Comply With IVDR Under Certain Conditions

Original from: 360dx

The European Parliament has agreed to adopt measures to delay certain deadlines of the In Vitro Diagnostic Medical Devices Regulation (IVDR) and to gradually roll out the European Database on Medical Devices (Eudamed), the European Commission said on Thursday.​

The Parliament agreed to adopt the measures, originally proposed in January by the EC, to give medical device manufacturers, including in vitro diagnostic developers, more time to apply the IVDR rules under some conditions. The EC proposed the measures after data found that "a considerable number" of IVDs in Europe didn't meet the rules, which began rolling out in 2022. It also found that some new devices that do comply with the new rules have not yet replaced older devices.

With the adoption of the new measures, high individual and public health risk devices will have until December 2027 to comply with the IVDR, while high individual and/or moderate public health risk devices have a December 2028 deadline to comply with the IVDR. Lower risk devices will have a December 2029 deadline. 

Additionally, at the start of 2026, the use of several parts of Eudamed will be mandatory, a move that will "increase transparency in the EU and provide an overview of medical devices available on the European market," the EC said.

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Source: European Parliament Agrees to Give IVD Firms More Time to Comply With IVDR Under Certain Conditions