EU: Two new and one updated guideline have been published and approved by the MDCG

In February 2020, two new guidelines MDCG 2022-3 and MDCG 2022-4 and a new version of guideline MDCG 2021-21 Rev.1 were 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 harmonised implementation of the legislation.

MDCG Guideline 2022-3 Verification of manufactured class D IVDs by notified bodies was issued on 15 February 2022. This guideline is important for manufacturers of Class D IVD devices because it provides a detailed specification of the requirements for a test plan for samples of manufactured Class D devices or batches of devices and arrangements to be made between manufacturers, notified bodies (NBs) and EU reference laboratories (EURLs) to maintain these devices on the EU market. Without a successful batch verification process a Class D device is not permitted to be placed on the EU market.

EURL will be important in the conformity assessment process for Class D devices, but no EURL has been named so far. According to the IVDR joint implementation and preparation plan, they will be designated in the first quarter of 2023. If no appropriate EURL is designated, the guideline opens the possibility for the NB to carry out a verification of manufactured Class D devices or batches of Class D devices without EURL involvement.

MDCG Guideline 2022-4 Guidance on Appropriate Surveillance of Transitional Provisions under Article 120 of the MDR was issued on 16 February 2022. The guideline explains how notified bodies implement assessments of transitional devices * during the period specified in Article 20 of the MDR. The document provides guidance on four different assessment options. For MDD devices of Class IIa and IIb, the assessments of the technical documentation shall be continued based on sampling in accordance with the existing sampling plan prepared by the notified body within the MDD.

The annex to the document contains a comparison table – quality management system requirements in the MDD and the MDR.

* Legacy device means a device that complies with the third paragraph of Article 120 of the MDR placed on the market after the date of application of the MDR and until 26 May 2024, if certain conditions are fulfilled. Those devices can be:  devices which are class I devices under MDD, for which an EC declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure under the MDR requires the involvement of a notified body or devices covered by a valid EC certificate issued in accordance with AIMDD or the MDD prior to 26 May 2021..

An updated guideline MDCG 2021-21 Rev.1 – Guidance on the performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices was issued on 15 February 2022. These are minor editorial explanations in Tables 1, 2, 4, 5, 6 and 7. The Guideline is addressed to all stakeholders, to IVD manufacturers of SARS-CoV-2, as well as to notified bodies and competent authorities, authorized representatives, other market players, professional associations, and patient associations.

The content of this guidance document is intended as a basis for common specifications to be adopted in accordance with Article 9 of the IVDR in the coming months.

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Guideline MDCG 2022-3 Verification of manufactured class D IVDs by notified bodies, web page EK, 15 February 2022

Guideline MDCG 2022-4 Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR, web page EK, 16 February 2022

Guideline MDCG 2021-21 Rev.1 – Guidance on performance evaluation of SARS-CoV-2, web page EK, 15 February 2022