MDCG-Update July 2024

The Medical Device Coordination Group (MDCG) has published additional documents regarding the implementation of the Medical Device Regulation (MDR).

In the following, we provide brief summary of selected MDCG-Documents, which should help you to identify those that are of interest to you.

• MDCG 2024-10 (June 2024): „Clinical evaluation of orphan medical devices“
  • This document is a guideline for the clinical evaluation of devices that are considered orphan products or have an orphan indication as defined in this guideline. It should be read in conjunction with other MDCG guidelines on clinical investigation and evaluation of medical devices (MDCG 2020-5, MDCG 2020-6 und MDCG 2023-7). Custom-made devices, in-house devices, devices without an intended medical purpose listed in Annex XVI of the MDR and in vitro diagnostic medical devices are not within the scope of this guideline.
• MDCG 2022-13 Rev.1 (June 2024): „Designation, re-assessment and notification of conformity assessment bodies and notified bodies“
  • This document is addressed to the authorities responsible for designating notified bodies. It is not relevant to manufacturers.
• MDCG 2022-4 Rev. 2 (May 2024): “Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD“. 
  Adjustments have been made throughout the document with regard to the transitional provisions for certain medical devices:
  • The amended Article 120 of the Medicine Device Regulation (MDR) states that devices for which a Notified Body The amended Article 120 of the Medicine Device Regulation (MDR) states that devices for which valid certificates have been issued by a Notified Body in accordance with the Active Implantable Medical Device Directive (AIMDD) or the Medical Device Directive (MDD) may be placed on the market or put into service after the date of application of the Medicine Device Regulation under certain conditions until December 31, 2027:
    1. 31. December 2027 for all class III products and for class IIb implantable devices, with the exception of suture materials, staples, dental fillings, dental braces, dental crowns, screws, wedges, plates, wires, pins, clips and connectors;
    2. until 31. December 2028 for some Class IIb products, Class IIa products and Class I products that are placed on the market in a sterile condition or have a measuring function.
  • The above conditions require, inter alia, that a Notified Body - either the one that has issued the certificate under the Medical Device Directive or the Active Implantable Medical Device Directive or the one with which the manufacturer has signed the written agreement for the Medicine Device Regulation certification - continues to carry out appropriate surveillance in relation to all applicable requirements for the existing devices subject to the surveillance requirements referred to in Article 120(3e). 
  • At this point we also refer to the document MDCG 2020-3 Rev. 1 (Information on significant changes in relation to the transitional provision under Article 120).
• MDCG 2024-6 (May 2024): “Preliminary re-assessment review template – MDR”
  • This guideline is addressed to the notified bodies and includes a document evaluation checklist.
• MDCG 2024-7 (May 2024): “Preliminary assessment review template – MDR”
  • This guideline is addressed to the notified bodies and includes a document evaluation checklist. 
• MDCG 2024-5 and appendix A (April 2024): “Guidance on content of the Investigator’s Brochure for clinical investigations of medical devices”
  • This guide is intended to help sponsors prepare their investigator brochures. It describes in more detail what type of information is expected in the respective sections of the investigator brochure. 
• MDCG 2024-3 and appendix A (März 2024): „Guidance on content of the Clinical Investigation Plan (CIP) for clinical investigations of medical devices“
  • This guideline is intended to support sponsors in the development of their „Clinical Investigation Plan“. It describes in detail what type of information is expected by the authorities in the respective sections of the CIP during the assessment.

We would be happy to discuss our views on the current requirements and transition periods with you.



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