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 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’.
MDCG Guideline 2022-6 Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR was issued on 4 May 2022. This document explains the concept of ‘significant changes in the design and intended purpose’ under IVDR Article 110(3). It concerns manufacturers of devices that are compliant with Directive 98/79/EC (IVDD) and that are placed on the market or put into service after 26 May 2022 during the transition period in accordance with Article 110(3) IVDR, irrespective of whether or not those devices required notified body involvement under the IVDD.
The conditions for the application of the transitional provisions in Article 110(3) IVDR are that the devices continue to comply with the IVDD and that there are no significant changes in the design or intended purpose of the device after the date of application of the IVDR. Therefore, it is important for manufacturers and notified bodies to have a clear understanding as to what changes to design or intended purpose would be considered ‘significant’ under Article 110(3) IVDR.
The annex to the document contains a chards of design changes and changes of the intended purpose which may be considered ‘significant’ when interpreting the first sentence of IVDR Art. 110(3).
This document provides a template of the Summary of safety and performance (SSP), which is required by Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). Article 29 of IVDR states that the manufacturer shall draw up a 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).
The SSP template for devices not intended for self-testing is presented in Section 1 and the SSP template for devices intended for self-testing is presented in Section 2 of the document.
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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, web page EC, 20 May 2022