Medical Device Coordination Group (MDCG) updates – Apr to Jun 2024

DateGuidance NoAbout the guidance
25 Jun 2024MDCG 2024-10Clinical evaluation of orphan medical devices – June 2024

This document provides guidance to manufacturers and notified bodies on the clinical evaluation pursuant to the MDR of medical devices and accessories for medical devices that qualify as ‘orphan devices’ (OD) and medical devices and accessories for medical devices that have an orphan indication, within the meaning of this guidance. This guidance is relevant to devices across all risk classes as per the classification rules defined in the MDR.

This guidance gives particular attention to the clinical evaluation and investigation requirements stated in MDR Chapter VI and Annex XIV for these devices. Where relevant, this guidance should be read in conjunction with other MDCG guidance on the clinical investigation and evaluation of medical devices, including MDCG 2020-5, MDCG 2020-6, and MDCG 2023-7.

Custom-made devices, in-house devices, products without an intended medical purpose listed in MDR Annex XVI and in vitro diagnostic medical devices are outside the scope of this guidance.

Please note, this document gives guidance on the clinical evaluation of orphan devices which require clinical data to demonstrate conformity with GSPRs. Guidance is not provided in this document for those specific circumstances where MDR Article 61(10) applies to an orphan device.
17 Jun 2024 MDCG 2022-13 Rev.1Designation, re-assessment and notification of conformity assessment bodies and notified bodies – June 2024

Rev. 1 – Document updated to include guidance on the conduct of joint assessments relating to extending the scope of designations
11 Jun 2024MDCG 2024-1-5 Guidance on the vigilance system for CE-marked devices – Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence (June 2024)

The aim of this Device Specific Vigilance Guidance (DSVG) is to harmonise vigilance reporting and provide guidance for manufacturers of Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence.

It provides further clarification for vigilance reporting of Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence to the relevant Competent Authority and should be read in conjunction with the requirements of Regulation (EU) 2017/745 on medical devices (MDR) . This DSVG does not replace or extend any of those requirements.
May 2024MDCG 2022-4 –Revision 2Guidance 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

In Revision 2, the document has been updated/amended throughout to align it to Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.
May 2024MDCG 2024-9Preliminary re-assessment review (PRAR) form template (IVDR)
May 2024MDCG 2024-8Preliminary re-assessment review (PRAR) form template (MDR)
May 2024MDCG 2024-7Preliminary assessment review (PAR) form template (IVDR) 
May 2024MDCG 2024-6Preliminary assessment review (PAR) form template (MDR) 
17 Apr 2024MDCG 2024-5Guidance on content of the Investigator’s Brochure (IB) for clinical investigations of medical devices – April 2024

When a sponsor of a clinical investigation shall submit an application according to article 70(1) of the MDR, the application shall be accompanied by the documentation referred to in Chapter II of Annex XV of the MDR. The Investigator’s Brochure (IB) is part of the required documentation and is one of the means by which the sponsor is to fulfil the requirement in section 2.7 of Chapter I of Annex XV of the MDR which states that the investigator shall have access to technical and clinical data regarding the device that is being investigated

This guidance document is intended to support sponsors in developing their IB by describing in greater detail what type of information is expected in the respective IB sections, in order to preempt questions from the competent authorities during the assessment of the clinical investigation application. The guidance is based on the requirements of both the MDR and ISO14155:2020 as well as experience from the competent authorities.
15 Apr 2024MDCG 2024-4 Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746 – April 2024

This document defines SAE reporting modalities and includes a summary tabulation reporting format.
15 Apr
2024		Update – MDCG 2022-9 rev.1Summary of safety and performance template – April 2024

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) requires that the manufacturer shall draw up a summary of safety and performance (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 changers to the document are stated on page 2.