In May, a new guideline, MDCG 2022-8 was published on the website of the European Commission and approved by the Medical Devices Coordination Group (MDCG). The guidelines are drafted in collaboration with interested parties represented in the various groups and are not legally binding. They present a common understanding of how the MDR and IVDR should be applied in practice aiming at an effective and harmonized implementation of the legislation.
MDCG Guideline 2022-8 Regulation (EU) 2017/746 – application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC was issued on 20 May 2022. The document states legal provisions as per Article 110(3) of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), amended by Regulation (EU) 2022/112. Regulation (EU) 2022/112 extended the transitional provisions of IVDR, in particular its Article 110(3), in terms of scope and timing. Similar as the guideline MDCG 2021-25 on transitional provisions of Regulation (EU) 2017/745 on medical devices (MDR), this document provides guidance as regards the applicability of IVDR requirements to ‘legacy devices’ and ‘old’ devices.
The annex contains a non-exhaustive table illustrating IVDR requirements applicable or not applicable to ‘legacy devices’.
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