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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 program of the event is available only on Ukrainian
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Read moreThePharmaMedia The first independent pharmaceutical business portal. Medical devices and medical devices for in vitro diagnostics play a fundamental role in modern medicine. However, although both categories use the term “medical devices,” they have important differences in their purpose, use and regulation. The text of the article is available only in Ukrainian
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