MD or not MD? What the ANSM guide to borderline cases really says (April 2025)

News

04 April 2025

1. Why we've been waiting for this guide

Since the entry into force of Regulation (EU) 2017/745 on medical devices (MDR) and 2017/746 on IVDDs (IVDR), manufacturers have been faced with a headache: correctly qualifying their product. Some cases are obvious... others much less so.

Should a cryotherapy cabin be considered a medical device? A non-sterile surgical gown? A mass spectrometer?

Faced with this complexity,in early April 2025 theANSM published an official positioning list, dated December 2024, which reviews 55 typical cases. This document is eagerly awaited, as it provides practical answers to questions that many people are asking, or should be asking themselves.

2. What is the purpose of this ANSM guide?

This document aims to :

Clearly define the scope of application of MDR and IVDR
Qualify ambiguous products (DM, IVDD, accessory, PPE, biocide, laboratory product...)
Avoid qualification errors that can lead to :

market withdrawal,
regulatory non-compliance,
or non-validation of the file by the notified body.

Please note: this guide is not legally binding. It reflects the ANSM's current position, but the final responsibility for qualification remains with the manufacturer.

3. What types of borderline cases are covered?

The list covers a wide range of products, organized by theme. Here is a summary:

Typology	Examples	Frequent statuses
Textiles & protection	Blouses, gowns, overshoes, gloves, blindfolds	DM, PPE or non DM depending on use
Hygiene & disinfection	Disinfectants, surgical brushes, water filters	DM if used directly on DM or patient
DM accessories	Contact gel, containers, bed-head sheaths	DM or accessories if medical purpose
Aesthetics / Sport	Depilatory appliances, cryotherapy, sports wheelchairs	Sometimes DM according to claim
Laboratory / Environment	Pipettes, balances, CO₂, isolators	Most often outside the scope of DM
Complex devices	PRP, systems with drugs, software	Cases to be analyzed in detail

This thematic approach makes reading the document particularly useful for manufacturers. It contains both common-sense confirmations... and a few surprises.

4. Concrete examples: focus on 2 case studies

Case 1 - Ultrasound transmission gel: mere cosmetic or DM accessory?

A gel designed to improve transmission between an ultrasound probe and the skin is a medical device accessory. It must therefore be :

cE-marked under Regulation (EU) 2017/745,
accompanied by clear instructions,
and have an explicitly claimed medical purpose.

Please note: a "universal" gel with no mention of medical use cannot benefit from this status.

Case 2 - Cryotherapy cabin: well-being or class IIb medical device?

Cryotherapy cabins come under class IIb if they are :

used for medical purposes (pain relief, inflammation reduction, etc.),
designed to produce an action on the body by energy transfer (temperatures close to -110°C),
potentially hazardous to health (risk of hypoxia, frostbite, etc.).

Classification is based on rule 9 of Appendix VIII of the MDR. If the aim is simply "well-being", and the claim is duly substantiated... the classification may change. But the consistency of promotional documents is essential.

5. What this means for manufacturers

This guide reminds us of one thing: it's not a product's appearance that determines its status, but its claimed purpose of use.

Here's what you need to do:

Document the intended purpose in the package insert, labeling and communication.
Be consistent between clinical, technical and marketing elements.
Carry out a regulatory qualification analysis at the design stage.
Prepare a traceable qualification sheet, with justification of status.

At CSDmed, we use robust decision-support grids to help you determine whether your product is a DM, an IVDD, an accessory, a PPE... or none of these.

6. Mini FAQ

Can a product be both PPE and a DM?

Yes, like medical gloves. In this case, it must meet the requirements of both regulations (DM and PPE) and be assessed for both purposes.

What if the medical purpose is "implicit" but not mentioned?

The ANSM bases its decision on all available information (leaflets, advertising, labelling). An implicit purpose may be sufficient to qualify a product as a medical device.

Can I change my mind after marketing?

Not without consequences. Any change in status requires a revision of the technical documentation, or even the CE mark.

Are ANSM position statements binding?

No, but they reflect the current doctrine of the competent authority. Ignoring them presents a high risk in the event of an inspection.

Does this guide cover combination products?

No. Combination products are subject to specific regulations (article 117 MDR), which are not covered here.

7. What you need to know (and how CSDmed can help)

The publication of this list of positionings by the ANSM is excellent news. It makes it possible to :

avoid unpleasant regulatorysurprises,
clarify frequent grey areas,
and professionalize the qualification process.

But it does not replace a tailor-made analysis, contextualized to your product, your markets and your ambitions.

At CSDmed, we support manufacturers from the earliest stages of development to qualify their product correctly, avoid dead-ends and build a solid regulatory strategy, right from the start.

Write to us: a simple exchange can save you a lot of headaches.

8. Related resources

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