EU guidance documents offer additional details on MDR transition

The European Union’s Medical Device Coordination Group (MDCG) published three new guidance documents and revised existing ones. Much of this new material addresses issues resulting from the transition from the Medical Devices Directive (MDD) and In Vitro Diagnostic Devices Directive (IVDD) to the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). Read on for an overview of the new publications and revisions.

First new MDCG guidance documents of 2020

• MDCG 2020-1: Guidance on Clinical Evaluation (MDR)/Performance Evaluation (IVDR) of Medical Device Software 
  • Outlines the framework for identifying the appropriate level of clinical evidence required for Medical Device Software (MDSW) to meet the requirements of the MDR. This document aligns with some concepts from related IMDRF guidance documents.
• MDCG 2020-2: Class I Transitional provisions under Article 120(3 and 4) – (MDR)
  • Describes the relevant information to be included in the manufacturer’s Declaration of Conformity (DoC) under the MDD for Class I (non-sterile/non-measuring) devices that must have MDR certificates after May 24, 2024.
• MDCG 2020-3: Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD 
  • Specifies what constitutes a “significant changes in design or intended purpose” under Article 120(3) of the MDR. It also states that such changes will no longer be issued new MDD/AIMDD certificates. Additionally, the device will be prevented from being placed on the market under the MDD/AIMDD after the implementation of the MDR. Finally, the guidance includes decision flowcharts to help manufacturers decide whether or not a change to a device will be considered significant.

Revisions to existing guidances, including expanded UDI-DI change criteria

• MDCG 2018-1 v3: Guidance on BASIC UDI-DI and changes to UDI-DI 
  • Revisions include additional criteria to consider that may or may not warrant a new UDI-DI under the “Changes of UDI-DI section.”
• MDCG 2019-8 v2: Guidance document on Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
  • Minor revisions include a clarification of the “MD” symbol (Footnote 7) and a note on language translations provided in the implant card examples (Footnote 9).

Related European MDR resources available from Emergo by UL:

• EU MDR compliance preparation and resource center
• European Authorized Representative in-country representation
• Whitepaper: Understanding Europe’s new Medical Devices Regulation
• Webinar: Eudamed requirements under the EU MDR and IVDR