Non-binding guidance that becomes a de facto requirement
The Medical Device Coordination Group publishes guidance documents that clarify the application of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). These texts are not legally binding. Article 105 of the MDR states that they reflect the consensus position of the group, made up of the representatives of the Member States and chaired by the European Commission. They create no new obligation.
This legal reading is correct. It is also misleading in practice.
Notified bodies review technical files using the MDCG guidelines as an operational reference framework. A file that ignores guidance published six months earlier exposes itself to a major non-conformity or to a request for additional information that pushes certification back by several months. The real status of the guidelines is not legal. It is procedural. That is what a regulatory affairs manager must keep in mind.
Our position: MDCG monitoring is not an optional compliance exercise. It is a component of the quality management system within the meaning of ISO 13485:2016, clause 4.1.
Five 2023-2024 publications to integrate into your technical file
Around thirty documents were published or revised between January 2023 and December 2024. Not all of them carry the same impact. Five of them require concrete action for manufacturers engaged in MDR CE marking of class I, IIa or IIb.
Regulation (EU) 2023/607: the foundation of the extended transitional regime
Published on 15 March 2023, this regulation amends Article 120 of the MDR. It extends the transitional periods for devices certified under Directives 90/385/EEC and 93/42/EEC.
The updated deadlines:
- 31 December 2027 for class III devices and implantable class IIb devices (excluding sutures, staples, dental fillings, orthodontic appliances, crowns, screws, wedges, plates, guide wires, pins, clips and connectors).
- 31 December 2028 for non-implantable class IIb devices, class IIa devices, class I devices placed on the market sterile or with a measuring function, as well as for the devices concerned that are up-classified under the MDR.
Cumulative conditions: formal application submitted to a notified body before 26 May 2024, assessment contract signed no later than 26 September 2024, no significant change to the design or intended purpose.
Several MDCG Q&As have since clarified the notion of a “process initiated with a notified body” and the scope of the modifications considered significant. These clarifications are enforceable. A manufacturer that has “initiated” a process without meeting the formalisation criteria does not benefit from the transitional regime.
MDCG 2019-07 Rev.1 (December 2023): manufacturer PRRC and authorised representative PRRC
Revision 1 of the document on the PRRC (Person Responsible for Regulatory Compliance, Article 15 MDR) fully restructures the text. The major changes for a manufacturer:
- Acceptable qualifications: clarification of what constitutes a recognised “course of study”, with a requirement of equivalence to a university degree in at least one Member State.
- Professional experience: it must be substantial, recent and connected to European regulation. Non-EU experience is accepted only if its relevance is demonstrated.
- At-risk configuration MDCG 2019-07: for a micro or small enterprise that outsources its PRRC, the manufacturer’s PRRC and that of its European authorised representative cannot belong to the same external organisation. This configuration constitutes a non-conformity under MDCG 2019-07 (Article 15 MDR).
Concrete impact: if you are a non-EU manufacturer that has entrusted your PRRC and your EC REP mandate to the same provider, the configuration must change. Notified bodies have been checking this point since 2024.
MDCG 2024-3 (March 2024): clinical investigation plan
This document provides a binding framework for the content of the Clinical Investigation Plan required under Annex XV chapter II of the MDR. Appendix A offers a synopsis template.
What changes: manufacturers of class IIa, IIb and III devices that conduct a clinical investigation must now align their documentation with this structure. A plan drafted in a free format is admissible in law. In practice it triggers systematic reformatting requests during the review by the notified body or the competent authority.
MDCG 2024-10 (June 2024): orphan devices and clinical evaluation
This document acknowledges the specific clinical evaluation difficulties for low-volume devices or devices intended for rare populations. It defines the criteria qualifying a device as “orphan” and opens the possibility of accepting certain limitations in pre-market clinical data, subject to reinforced PMCF.
For a manufacturer concerned, this guidance is an opportunity. It offers an admissible line of argument where the requirement for clinical data equivalent to a device of an equivalent class would have blocked certification. But the file must explicitly justify the orphan status according to the MDCG 2024-10 criteria. A file that invokes rarity without complying with this grid will be refused.
MDCG 2020-16 Rev.3 (July 2024): classification of in vitro diagnostic devices
This revision consolidates the classification rules for IVDs under the IVDR. It does not directly affect MDR manufacturers. It concerns any organisation with a mixed MD/IVD portfolio, or whose medical software could fall under IVD qualification according to MDCG 2019-11 Rev.1.
A point of attention: the IVDR classification of software that produces a result used for diagnostic purposes can have serious consequences in terms of the conformity assessment procedure.
How to integrate MDCG monitoring into an ISO 13485 quality management system
Effective MDCG monitoring does not consist of receiving a weekly alert. It rests on three elements documented in the QMS.
A defined monitoring process: designated owner, single source of truth (the European Commission portal), consultation frequency. The recommended frequency is monthly. A quarterly consultation exposes you to an impactful revision being published before it is detected.
A traced impact analysis: each new publication must be the subject of a formal assessment. Three questions: does this text apply to my devices? Which documents in my technical file or my QMS are concerned? What is the compliance deadline?
An associated action plan: publications that require a documentary change are integrated into the improvement plan, with an owner and a deadline. This traceability is audited by the notified body during annual surveillance.
A manufacturer that cannot present any impact analysis of the MDCG guidelines published since its last certification exposes itself to a minor non-conformity. Repeated, this non-conformity becomes major.
Where to consult MDCG publications
The official list of MDCG documents is accessible on the European Commission portal: health.ec.europa.eu — Guidance MDCG. The publications are dated, the revisions identified by their number (Rev.1, Rev.2, etc.).
A subscription to the European Commission’s “Latest updates” page makes it possible to receive notifications at the source, without an intermediary.