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
The Ukrainian Scientific Institute of Certification invites you to take part in the 12th Ukrainian Forum of Medical Devices Market Operators®. In this difficult period for our country, more than ever, it is necessary to be aware of the latest key changes in the functioning of the medical device market. Therefore, the Ukrainian Forum of […]
Read moreJournal “Laboratory” No. 08/2020 The text of the article is available only in Ukrainian
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