MDCG-Update October 2024

The Medical Device Coordination Group (MDCG) has published further MDCG-Documents on the implementation of the Medical Device Regulation (MDR) .

In the following, we provide brief summary of selected MDCG-Documents. This way you can find what concerns you and/or interests you more quickly.

• DCG 2024-11 from October 2024: “Guidance on qualification of in vitro diagnostic medical devices”
  • The aim of this new guidance document is to clarify which products fall within the scope of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) – also known as ‘qualification’ as a In-Vitro-Diagnostic (IVD) or as an accessory for an IVD. To qualify as an IVD or as an accessory for an IVD, the product must fulfil the definition in Art. 2(2) or Art. 2(4) of the IVDR, respectively. The classification depends on the intended use as described by the manufacturer. This guidance document contains a non-exhaustive list of examples of IVDs and accessories for IVDs.

• MDCG 2024-12 from October 2024: “Corrective and preventive action (CAPA) plan assessment: guidance and templates for conformity assessment bodies, notified bodies, designating authorities, and joint assessment teams”,
  • “Annex I: Template CAPA plan and assessment thereon” AND
  • “Annex II: Template JAT review of the CAPA and the DA’s opinion”
  • This guide and its appendices are intended for Conformity Assessment Bodies (CABs), Notified Bodies (NBs), Designating Authorities (DAs) and Joint Assessment Teams (JATs) involved in the Medical Device Regulation (EU) 2017/745 (hereafter MDR) and the In Vitro Diagnostic Medical Device Regulation (EU) It should be read in conjunction with the guidance document MDCG 2022-13 ‘Designation, re-assessment and notification of conformity assessment bodies and notified bodies’.

• MDCG 2021-25 rev. 1 from October 2024: “Application of MDR requirements to „legacy devices“ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC”
  • 1st update (MDCG 2021-25 Rev. 1)
    Adjustments throughout the document to align with the general structure of the MDCG guidance documents and to take into account Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 202 3 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards transitional provisions for certain medical devices and in vitro diagnostic medical devices. Significant changes have been made in particular in sections 3.1, 3.2 and 4, namely:
    • Clarification that Article 19 of the MDR does not apply to old devices;
    • Clarification of the application of the transitional provisions to systems and procedure packages that have been established on the basis of a declaration in accordance with Article 12 (2) of the MDD.
    • Clarification of the requirement to QMS to be set up in accordance with Article 10(9) of the MDR.

• MDCG 2021-4 rev.1 from September 2024: “Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746”
  • This document provides guidance on the application of the IVDR provisions related to expert panels and the European Union Reference Laboratory (EURL) prior to the IVDR application date, i.e. 26 May 2022, and on the date when the first EURL designations for EURL tasks become applicable.

• MDCG 2020-16 Rev. 3 from July 2024: “Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 – July 2024”
  • This guidance on the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) addresses the classification of in vitro diagnostic medical devices (IVDs) and provides clarifications to the classification rules set out in Annex VIII. These classification guidelines also apply to diagnostic or information society services provided to EU patients or to products that are put into service at a distance.

• MDCG 2021-5 rev. 1 as of July 2024: “Guidance on standardisation for medical devices”
  • This updated document is intended to serve as a guide to various aspects related to standards in the field of medical devices, in order to support the requirements laid down in the applicable EU legislation, taking into account the respective specificities.

If you have any questions, please do not hesitate to contact us .

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