Medical Device Coordination Group (MDCG) updates – Oct to Dec 2024

DateGuidance NoAbout the Guidance
6 Dec 2024MDCG 2024-16Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices
2 Dec 2024MDCG 2024-15Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED (November 2024)

Article 77(5) MDR requires that the sponsor submits to the Member States in which a clinical investigation was conducted a clinical investigation report within one year of the end of the clinical investigation or within three months of the early termination or temporary halt, irrespective of the outcome of the clinical investigation. Furthermore, the clinical investigation report shall be accompanied by a summary presented in terms that are easily understandable to the intended user. Both the report and summary shall be submitted by means of EUDAMED.

Article 77(7) MDR require that the summary and the clinical investigation report shall become publicly accessible through EUDAMED at the latest when the device is registered in accordance with Article 29 and before it is placed on the market. In cases of early termination or temporary halt, the summary and the report shall become publicly accessible immediately after submission. If the device is not registered in accordance with Article 29 within one year of the summary and the report having been entered into EUDAMED pursuant to Article 77(5) MDR, they shall become publicly accessible at that point in time. These are the timelines for publication under this SOP.
26 Nov 2024MDCG 2024-14Guidance on the implementation of the Master UDI-DI solution for contact lenses (November 2024)

For contact lenses, which are devices presenting a high level of individualisation (‘highly individualised devices’), the assignment of a Master UDI-DI has been foreseen according to Annex VI, Part C, Section 6.6.1 MDR, as amended by Commission Delegated Regulation (EU) 2023/2197 on Master UDI-DI for contact lenses.

Even though all economic operators have to contribute to an appropriate level of traceability according to Article 25 MDR, the main responsibility to apply the means to achieve proper identification and traceability of the device lies with the manufacturer.

This document aims to provide guidance in the implementation of Master UDI-DI rules for contact lenses as regards its structure, assignment, labelling and registration in Eudamed.
11 Nov 2024MDCG 2023-3 rev.1Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 under Regulation (EU) 2017/746 – November 2024

This document aims to clarify important terms and concepts that are outlined in Section 2 of Chapter VII of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). Establishing a common understanding of these terms and concepts is necessary for the effective and harmonised implementation of the vigilance requirements under these Regulations.

Substantial changes have been made to this document and they are listed on pages 2-3.
29 Oct 2024MDCG 2024-13Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices – October 2024

The regulatory status of EtO is discussed under the following sections:
2.1. EtO sterilisation during the manufacturing process
2.2. EtO used by health institutions for sterilisation of medical devices before or after their use
29 Oct 2024MDCG 2022-5 rev.1Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices – October 2024

Borderline products are those where it is not clear from the outset whether they fall under the MDR or the MPD.

Several provisions to establish the demarcation between the two legal frameworks have been laid down in the MDR and MPD.

This document provides further explanations and examples clarifying these provisions in order to support the uniform application of the MDR across the EU.

The change to the document (stated on page 2) concerns section 1.2.6.1 Examples of medical devices, to which the following bullet point has been added:
• products specifically intended for the cleaning, disinfection or sterilisation of medical devices
16 Oct 2024MDCG 2021-25 rev.1Application 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 (October 2024)

This document provides updated guidance as regards the applicability of MDR requirements to ‘legacy devices’ and ‘old’ devices, taking into consideration the amendments to the MDR transitional provisions. The annex contains a non-exhaustive table illustrating MDR requirements applicable or not applicable to ‘legacy devices’.

The updates are:
Adjustments in the entire document to align with the general structure of MDCG guidance documents (e.g. removal of Preface, Mandate of taskforce and process) and to take into account Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. Substantial changes are in particular in sections 3.1, 3.2 and 4, namely:
• clarification that Article 19 MDR does not apply to legacy devices;
• clarification of the application of the transitional provisions to systems and procedure packs covered by a declaration drawn up pursuant to Article 12(2) MDD;
• clarification regarding the requirement to put in place a QMS in accordance with Article 10(9) MDR.

8 Oct 2024MDCG 2024-11Guidance on qualification of in vitro diagnostic medical devices (October 2024)

The purpose of this guidance document is to clarify what products fall in scope of Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) – also referred to as ‘qualification’ as an in vitro diagnostic medical device (IVD) or an accessory to an IVD.

In order to be qualified as an IVD or an accessory to an IVD, the product must fulfil the definition in Art 2(2) or Art 2(4) of the IVDR respectively. The qualification depends on the intended purpose as described by the manufacturer.
7 Oct 2024MDCG 2024-12 Corrective and preventive action (CAPA) plan assessment: guidance and templates for conformity assessment bodies, notified bodies, designating authorities and joint assessment teams

This guidance document is intended for conformity assessment bodies (CABs), notified bodies (NBs), designating authorities (DAs), and Joint Assessment Teams (JATs) involved in Regulation (EU) 2017/745 on medical devices (hereafter MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (hereafter IVDR).

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”.

This document aims to provide guidance for: −
• NBs when establishing the corrective and preventive action (CAPA) plan to address the non-compliances (NCs) resulting from joint assessments according to Article 39(5) of the MDR or Article 35(5) of the IVDR
• authorities responsible for notified bodies (hereafter, the DAs) when conducting reviews of and providing opinions on CAPA plans of notified bodies according to Article 39(7) of the MDR or Article 35(7) of the IVDR
• JATs when considering the CAPA plan and the DA’s opinion thereon according to Article 39(7) of the MDR or Article 35(7) of the IVDR.