19.09.2022
To the attention of manufacturers of in vitro diagnostic medical devices, economic operators, notified bodies and all stakeholders
Please be informed that on 14 September 2022, the European Commission published the MDCG 2022-15 Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD.
This document provides information related to Article 110 (2) and Article 110 (3) of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) states that medical devices covered by valid certificates issued by a body notified in line with Directive 98/79/CE on in vitro diagnostic medical devices – IVDD can be marketed or commissioned after date of enforcement of the IVDR, no later than 26 May 2025, in some cases.
The abovementioned conditions require that the notified body which has issued the certificate in line with the IVDD continues to carry out appropriate supervision regarding the applicability of the requirements related to the devices it has certified. It is thus important for manufacturers, notified bodies and national authorities to be clear about the activities taking part in the appropriate surveillance referred to in Article 110(3) of the IVDR.
To properly address the application of transitional provisions to medical devices covered by certificates issued in line with the IVDD, this guideline, issued in accordance with MDCG 2022-4 Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR (https://health.ec.europa.eu/latest-updates/mdcg-2022-4-guidance-appropriate-surveillance-regarding-transitional-provisions-under-article-120-2022-02-16_en) and MDCG 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 (https://health.ec.europa.eu/latest-updates/mdcg-2022-8-regulation-eu-2017746-application-ivdr-requirements-legacy-devices-and-devices-placed-2022-05-20_en), should be read in conjunction with MDCG 2022-6 – Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR (https://health.ec.europa.eu/latest-updates/mdcg-2022-6-guidance-significant-changes-regarding-transitional-provision-under-article-1103-ivdr-2022-05-04_en).
For the purpose of this document, „legacy devices” should be understood as devices which, in line with Article 110 (3) of the IVDR, are placed on the market following enforcement of the IVDR (26 May 2022) and until the end of the respective transition period mentioned in Article 110 (3) – the 2nd or 3rd paragraph, if certain conditions are met.
Only devices covered by a valid CE certificate, issued in accordance with the IVDD prior to 26 May 2022, are covered in this guide.
The notification of the European Commission is available online: https://health.ec.europa.eu/system/files/2022-09/mdcg_2022-15_en.pdf.