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Three new guidance documents related to IVD medical devices available

Three guidance documents regarding in vitro diagnostic medical devices were published in May by the Medical Devices Coordination Group (MDCG):

1. MDCG 2022-6: GUIDANCE ON SIGNIFICANT CHANGES REGARDING THE TRANSITIONAL PROVISION UNDER ARTICLE 110(3) OF THE IVDR:

This document provides guidance on how the significance of legacy product changes should be evaluated after the date of application of the IVD Regulation (EU 2017/746), the 26th of May 2022. It is worth noting that although IVD products that are already on the EU-market may be placed on the market after the date of application without fully complying with the IVDR, no significant changes shall be made to the products. Significant changes to the design or intended purpose of the product requires the product to be placed on the EU market under the IVDR. This guide is based on the previously published medical device guidance document MCDG 2020-3.

Read more: https://ec.europa.eu/health/system/files/2022-05/mdcg_2022-6.pdf

2. 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 IN ACCORDANCE WITH DIRECTIVE 98/79/EC

This guidance document defines the term ‘legacy device’, and it also provides information on which IVDR requirements apply to legacy devices. As defined by the guidance document, IVDR requirements that are not related to post-market surveillance, market surveillance, vigilance, registration of economic operators and devices should not, in principle, apply to economic operators in respect to ‘legacy devices’. Interestingly, the guidance document says that IVDR Article 80 (PMS report) should, as a minimum requirement, apply to all legacy devices, unless a manufacturer of ‘legacy devices’ that will fall under class C or D voluntarily prepares a PSUR pursuant to Article 81.

Find out more: https://ec.europa.eu/health/system/files/2022-05/mdcg_2022-8_en.pdf

3. MDCG 2022-9: SUMMARY OF SAFETY AND PERFORMANCE TEMPLATE

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) requires that the manufacturer shall draw up a summary of safety and performance (SSP) for class C and D devices, other than devices for performance studies. The SSP shall be validated by a notified body (NB) and made available to the public via the European database on medical devices (Eudamed). MDCG 2022-9 provides a template for the SSP.

Link to template: https://ec.europa.eu/health/system/files/2022-05/mdcg_2022-9_en.pdf