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EU Parliament have approved the EU Commission’s proposal published on 23/1/24

By April 29, 2024No Comments

The European Parliament have approved the European Commission’s (EC) proposal published on January 23, 2024.

This proposal asks to amend the EU MDR (2017/745) and EU IVDR (2017/746) regarding the transitional extension for certain IVD devices, gradual roll out of EUDAMED and obligations in case of supply interruption.

What does this mean?

The additional time granted to manufacturers depends on the type of device and they will need to inform in advance if certain IVD medical devices become unavailable.

The proposal also allows for the gradual roll-out of the European Database on Medical Devices (EUDAMED).

See our regulatory update for full details and support.

We will cover this at our next Regulatory Affairs Working Party on 14 June. In the interim, please contact our Regulatory Affairs team at with any queries.

You can find the proposal here and the European Commission’s press release here.

Ben Kemp