Public health: more time to certify medical devices to mitigate risks of shortages

09.01.2023

On January 6, 2023 the European Commission adopted a proposal to give more time to certify medical devices to mitigate the risk of shortages. The proposal introduces a longer transition period to adapt to new rules, as foreseen under the Medical Devices Regulation. The new deadlines depend on the medical devices’ risk class and will ensure continued access to medical devices for patients. It will also allow medical devices placed on the market in accordance with the current legal framework and that are still available to remain on the market (i.e., no ‘sell-off’ date).

Full text of the document >>> https://ec.europa.eu/commission/presscorner/detail/en/ip_23_23

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