Medical Device Coordination Group updates: October – December 2023

Guidance No.About the guidance
MDCG 2023-7 Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR – December 2023

This guidance is intended to clarify the exemptions from the requirement to perform clinical investigations and associated conditions related to the demonstration of equivalence, for implantable and class III medical devices to be placed on the European market. It also provides examples and considerations relevant to the demonstration of “sufficient levels of access to the data” per Annex XIV Section 3.
Update – MDCG 2021-27 – Rev.1Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 – December 2023

This document presents questions and answers on requirements related to importers and distributors under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR.

The questions covered by the document aim to provide further detail on the operational and practical implementation of Articles 13 and 14 and other related obligations for importers and distributors under the Regulations. Activities described in Article 16 of the Regulations are covered in other guidance documents, including MDCG 2018-6, MDCG 2021-23 and MDCG 2021-26.

The revisions are detailed on page 2 of the document.
Update – MDCG 2019-7 – Rev.1Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a PRRC – December 2023

This document provides guidance on the roles and obligations of the PRRC and is addressed to manufacturers, authorised representatives and PRRCs.

The revisions are detailed on page 2 of the document.
MDCG 2023-6 Guidance on demonstration of equivalence for Annex XVI products – A guide for manufacturers and notified bodies – December 2023

This MDCG guidance covers the demonstration of equivalence, based on data pertaining to an already existing device, for the purpose of CE-marking under the MDR and is applicable to products without an intended medical purpose listed in the Annex XVI of MDR and covered by the CS. For dual-purpose devices, which are devices with a medical and a non-medical intended purpose, this guidance applies only to the non-medical intended purpose.

This guidance document should be used in conjunction with MDCG 2020-5 on equivalence.
MDCG 2023-5Guidance on demonstration of equivalence for Annex XVI products – A guide for manufacturers and notified bodies – December 2023

This guidance document provides elements useful for the qualification of a product as a product without an intended medical purpose listed in Annex XVI to the MDR. It also provides explanations and examples for the application of certain classification rules to products without an intended medical purpose, hereinafter also referred to as devices.
MDCG 2021-6 – Rev.1Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation – December 2023

The changes concern all of the following and are tabulated on page 2 of the document.
-New questions and answers
-Updated answers
-Updated questions
MDCG 2022-11 Rev.1MDCG Position Paper
Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements – November 2023

Revision 1 changes:
1) Section “Call to notified bodies to streamline the certification process” (new)
2) Section “Call to manufacturers to transition to the Regulations and submit their applications for certification without further delay” (revised)
MDCG 2023-4 Medical Device Software (MDSW) – Hardware combinations
Guidance on MDSW intended to work in combination with hardware or hardware components – October 2023

This guidance:
· intends to examine and provide clarifications on which specific regulatory considerations apply when the hardware or hardware component incorporating the data collection element (camera, electrical/optical sensors etc.) are a medical device or an accessory to a medical device.
· also outlines scenarios where the hardware or hardware component incorporating a data collection element are not medical devices or accessories to a medical device.
· does not intend to elaborate on aspects related to the clinical evaluation or cybersecurity for these products, as those are tackled in other guidance.