Compliance Checklist

CE Marking
Health & Medical
France 🇫🇷

CE marking for medical devices and health products on Amazon France: MDR requirements, risk classification, the French ANSM declaration obligation, and common mistakes.

Overview

Medical devices and health products in the EU are subject to the Medical Device Regulation (MDR) (EU) 2017/745 or the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 – unchanged in France as well. CE marking is mandatory for all medical devices. What sets France apart from many other EU states is an additional national declaration obligation: manufacturers, mandataries, importers, distributors, and sterilization service providers of medical devices operating in France must declare themselves to the Agence nationale de securite du medicament et des produits de sante (ANSM) under Art. L.5211-3-1 of the Code de la sante publique (CSP) – in addition to the European Eudamed database. A decree of 17 April 2026 (No. 2026-299) clarified and tightened these declaration duties in Articles R.5211-6 to R.5211-8 CSP.

Does this apply to my product?

This checklist applies to all economic operators selling medical devices with a medical intended purpose to consumers in France via Amazon.fr: blood pressure monitors, fever thermometers, blood glucose meters, pulse oximeters, wound care, orthopedic aids, compression stockings, medical masks, TENS devices, hearing aids, and in vitro diagnostics such as pregnancy or self-tests. It explicitly applies to pure distributors as well as manufacturers – the French declaration obligation under Art. L.5211-3-1 CSP covers all supply chain actors operating in France (excluding pure retail sale to the public).

Step-by-Step Guide

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Distinguish medical device vs. wellness product and determine risk class

The first decision is identical EU-wide: is the product a medical device within the meaning of the MDR, and if so, which risk class (I, IIa, IIb, III) does it fall into? This classification determines the entire certification process.

Estimated time: 1-2 Wochen / 1-2 weeks

Intended purpose defined and documentedRequired

A massage device 'for relaxation' is a wellness product (LVD/EMC Directive). The same device 'for treatment of muscle tension' is a medical device under MDR. Wording in the listing, packaging, and manual must be consistent.

Risk classification according to MDR Annex VIII completedRequired

Four risk classes: I (lowest risk), IIa (e.g. blood pressure monitors), IIb (e.g. ventilators), III (highest risk). The 22 classification rules in Annex VIII determine classification.

Classification report with justification of applied rules from MDR Annex VIII

Quality management system (QMS) and clinical evaluation

The MDR requires a complete QMS and clinical evaluation for all medical devices, including Class I – uniform across the EU.

Estimated time: 4-16 Wochen / 4-16 weeks

QMS according to EN ISO 13485:2016 implementedRequired

The QMS must cover design control, risk management, supplier evaluation, complaint handling, CAPA processes, and vigilance reporting.

QMS documentation according to EN ISO 13485

Clinical evaluation according to MDR Article 61 completedRequired

For Class I, a literature review and equivalence assessment is usually sufficient. From Class IIb onwards, clinical investigations may be required.

Clinical Evaluation Report (CER)

Create technical documentation according to MDR Annex II and III

The technical documentation must meet the requirements of MDR Annex II and III and, under MDR Art. 10(8), must remain available for at least 5 years – 15 years for implantable devices – after the last product is placed on the market.

Estimated time: 4-12 Wochen / 4-12 weeks

Technical documentation according to MDR Annex II compiledRequired

Product description, manufacturing information, general safety and performance requirements, risk management file, clinical evaluation, labeling, and instructions for use.

Complete technical documentation according to MDR Annex II

Post-Market Surveillance Plan (PMS Plan) createdRequired

Describes complaint tracking, vigilance reporting, and periodic safety update reports (PSUR from Class IIa).

Conformity assessment and Notified Body (from Class IIa)

From Class IIa onwards, involvement of an MDR-designated Notified Body is mandatory. France has its own MDR-designated Notified Body, LNE/G-MED; alternatively, Notified Bodies from other EU states (TUeV SUeD, TUeV Rheinland, DEKRA, BSI) can also be engaged.

Estimated time: 4-26 Wochen / 4-26 weeks

Conformity assessment procedure selected and Notified Body engagedRequired

Check the NANDO database for which Notified Bodies are designated for your product category. Expect several months of lead time for the contract and first assessment.

EU Declaration of Conformity issued and CE marking affixedRequired

The DoC must reference all applied MDR Annexes, the Notified Body identification number (from Class IIa), and the UDI-DI.

EU Declaration of Conformity according to MDR Article 19

ANSM declaration obligation and Eudamed registration

In addition to the European Eudamed registration, France requires its own declaration to the ANSM under Art. L.5211-3-1 CSP – for both manufacturers AND distributors. A decree of 17 April 2026 (No. 2026-299) clarified the rules in Art. R.5211-6 to R.5211-8 CSP.

Estimated time: 1-4 Wochen / 1-4 weeks

Submit declaration of activity to ANSM (manufacturer, mandatary, importer, distributor, sterilization provider)Required

Anyone manufacturing, distributing, importing, exporting, or sterilizing/assembling medical devices in France must declare via the 'Declaration d'activite des operateurs' form to the ANSM – regardless of the scale of the activity. The declaration is free of charge and submitted by email to communications.dm@ansm.sante.fr or by registered mail to ANSM (PGRef – Declarations/enregistrements DMDIV).

ANSM 'Declaration d'activite des operateurs' form including supporting documents

Designate materiovigilance correspondent (manufacturer/mandatary only)

Under Art. R.5212-14 CSP, manufacturers and their mandataries must declare a materiovigilance correspondent to the ANSM who reports serious incidents without delay. Pure distributors and importers are exempt from this specific correspondent obligation – but must still declare themselves as an economic operator per step 5.1.

Complete registration in the Eudamed 'Actors' moduleRequired

Since 28 May 2026, the first four Eudamed modules are mandatory to use. Economic operators who register in Eudamed are exempt from a parallel national registration of the same data – however, the ANSM activity declaration itself remains required.

French labeling and Amazon.fr listing compliance

Instructions for use and safety information must be provided in French for the French market. Amazon.fr additionally requires the complete GPSR and compliance mandatory fields per ASIN.

Estimated time: 1-2 Wochen / 1-2 weeks

Instructions for Use (IFU) created in FrenchRequired

The IFU must meet the requirements of MDR Annex I Chapter III and be provided in French (Code de la consommation, Loi Toubon). Symbols according to EN ISO 15223-1.

Category approval and GPSR mandatory fields in Amazon Seller CentralRequired

Medical devices on Amazon.fr often require category approval (CE certificate, DoC, Notified Body certificate). Additionally, complete the GPSR mandatory fields (responsible person, manufacturer data).

Common Mistakes to Avoid

Wellness product falsely marketed as a medical device (or vice versa)

Consequence: A wellness product marketed with medical claims is legally considered an unauthorized medical device – fines and a sales ban may follow.

Prevention: Define the intended purpose before product development and keep all marketing materials, listings, and packaging consistent with it.

Distributor mistakenly believes it is not subject to ANSM declaration

Consequence: Art. L.5211-3-1 CSP explicitly covers pure distributors, not just manufacturers. A distributor placing medical devices on the market in France without declaring violates the declaration obligation.

Prevention: Before the first sale on Amazon.fr, check whether a separate ANSM activity declaration as a distributor is required – regardless of a Eudamed registration already made by the manufacturer.

Confusing the materiovigilance correspondent obligation with the general activity declaration

Consequence: A manufacturer who believes the general ANSM declaration is sufficient without designating a materiovigilance correspondent under Art. R.5212-14 CSP violates a separate obligation.

Prevention: As a manufacturer or mandatary, explicitly designate a materiovigilance correspondent in addition to the activity declaration, and update the ANSM form whenever the contact person changes.

Incomplete ANSM declaration submitted

Consequence: Under Decree No. 2026-299, an incomplete declaration is deemed inadmissible (irrecevable) after 30 days – market entry in France is delayed accordingly.

Prevention: Submit all documents required by the ANSM form (identity, type of activity, affected products) complete with the initial application.

Instructions for use provided only in English or German

Consequence: Violation of the French language requirement for consumer information. Amazon.fr can suspend the listing, and competent authorities can intervene.

Prevention: Have the IFU, warnings, and packaging text professionally translated into French before listing on Amazon.fr.

Frequently Asked Questions

Q1Do I need to declare myself as a pure distributor to ANSM even if the manufacturer is already registered in Eudamed?

Generally yes. Art. L.5211-3-1 CSP requires a separate activity declaration from every distributor operating in France, regardless of the manufacturer's registration. The manufacturer's Eudamed registration does not replace your own declaration obligation as a distributor.

Q2What is the difference between the ANSM activity declaration and Eudamed registration?

Eudamed is the European database for economic operators and products; its first four modules have been mandatory to use since 28 May 2026. The ANSM activity declaration is an additional French filing under Art. L.5211-3-1 CSP that exists in parallel. Registering in Eudamed exempts you from duplicating the same data nationally, but you still must declare yourself to the ANSM as an active operator.

Q3Do I need a materiovigilance correspondent as a distributor?

No. The obligation to designate a materiovigilance correspondent with ANSM (Art. R.5212-14 CSP) applies only to manufacturers and their mandataries. Pure distributors and importers are exempt from this, but must still declare via the general activity declaration.

Q4What happens if my ANSM declaration is incomplete?

Under Decree No. 2026-299 of 17 April 2026, an incomplete declaration is deemed inadmissible (irrecevable) after 30 days. You must resubmit the missing documents and restart the process, which delays market entry.

Q5Can SpaceGoats help me with medical device compliance for Amazon.fr?

Yes, SpaceGoats offers support as an Amazon full-service provider for MDR compliance and coordinating French ANSM declarations. Contact SpaceGoats at spacegoats.io for individual consulting.

CE MarkingHealth & MedicalFrance 🇫🇷