Not for the first time since the introduction of the Medical Device Regulation (EU) 2017/745 and its IVDR (EU) 2017/746 sibling, we see changes to important timelines for medical device and IVD manufacturers. If approved, the latest proposal will provide some welcome breathing space for notified bodies where capacity to meet demand has proved challenging, and help prevent supply shortages for patients.
January 6th 2023 saw the European Commission present their proposal to extend the transition periods of the MDR, related to the placing on the market and putting into service, of products. However, the proposal must still be approved by the EU Parliament before the amendments can actually come into effect.
Once approved, the result will be to extend the transition periods for:
· Class III implantables (custom made) - to 26 May 2026
· Remaining Class III products and Class IIb implanatbles - to 31 December 2027
· Remaining Class IIb products, Class IIa, Is and Im - to 31 December 2028
· Remaining Class I products (a notified body is required) – also to 31 December 2028
The proposal also applies to the In Vitro Diagnostic Medical Device Regulation (EU) 2017/746, but only in respect to elimination of the ‘sell off’ period. This means that any IVDs that were already placed on the market before 26 May 2022, or within the applicable transition period for Class B, C and D diagnostics, can be sold without restriction.
The period for receiving comments on the proposal has now passed and the approval is anticipated. Whilst these changes to the transition periods do provide additional time for manufacturers to comply, and take some pressure our of the system, it is still recommended that they continue to work to comply as soon as possible.
Link to the proposal and comments received are on the European Commission website: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13684-Medical-devices-transition-period-extension_en
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