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Since the Technical Regulations entered into force, discussions on the possibility of simplifying conformity assessment procedures, especially for medical devices of high-risk classes have been underway. Recently, we have had positive and relevant news regarding the recognition procedures in Ukraine for certificates of conformity issued by some notified bodies, accredited in the EU. To put it simply – the recognition of EU certificates for medical devices.
The program of the event is available only on Ukrainian
Read moreThePharmaMedia The first independent pharmaceutical business portal. The text of the article is available only in Ukrainian
Read moreOn 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 […]
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