Dear customers, Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices enters into force on 26 May 2022 and establishes a new regulatory framework setting high standards of quality and safety for in vitro diagnostic medical devices. As a result of the COVID-19 pandemic crisis and the lack of notified bodies, which are necessary in the conformity assessment process for most IVDs under the new regulation, the EU fortunately adopted on 25 January 2022 a new Regulation (EU) 2022/112 amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices. This amendment extended the transitional periods laid down in Regulation (EU) 2017/746 for devices for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body until 2025-2027 according to the risk class of IVD. Article 110 of the Regulation enables that devices lawfully placed on the market pursuant to former Directive 98/79/EC prior to 26 May 2022 may continue to be made available on the market or put into service until 26 May 2025. The aforementioned legislation allows to EXBIO to sell IVD products manufactured and released by 25 May 2022 compliant with the requirements of former Directive 98/79/EC and gradually perform new conformity assessment according to the Regulation (EU) 2017/746 with the involvement of a notified body without interrupting the supply of IVD products to customers.
František Škrob, Ph.D. Director, QA & RA Department EXBIO Praha, a.s.,
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