France's Agence nationale de sécurité du médicament et des produits de santé (ANSM) is the Competent Authority for medical devices placed on the French market. Under MDR Article 31, manufacturers, authorised representatives, and importers register as economic operators through EUDAMED, and the Competent Authority of the Member State where the operator is established — ANSM for France — verifies that data. Alongside the EUDAMED path, France maintains national-level notification and surveillance duties that ANSM administers. Until the relevant EUDAMED modules are fully mandatory under MDR Article 34, French national obligations continue in parallel, and manufacturers selling into France should treat ANSM as an active Competent Authority counterpart, not just a database endpoint.

By Tibor Zechmeister and Felix Lenhard. Last updated 10 April 2026.

TL;DR

  • ANSM is France's Competent Authority for medical devices and the French counterpart to BfArM in Germany or BASG in Austria.
  • MDR Article 31 is the legal anchor for economic operator registration; it routes through EUDAMED, with verification by the Competent Authority of establishment.
  • France maintains national-level notification and surveillance duties that sit alongside the EUDAMED path while the relevant EUDAMED modules remain in transition under MDR Article 34.
  • For a non-French manufacturer selling into France, ANSM becomes relevant through vigilance, market surveillance, and language obligations — not only through registration.
  • The Subtract to Ship rule: do the MDR Article 31 EUDAMED work cleanly, then check the current ANSM national notification position for your specific device class rather than copying what worked in another Member State.

A founder emails us the week before the French launch

A founder who was weeks away from a French hospital pilot sent the email we get a version of every month. The short form was: "We registered in EUDAMED. A French distributor just told us we also have to declare our device to ANSM. Is that real, or is the distributor confused?"

The honest answer is that both things can be true at the same time. MDR Article 31 economic operator registration is an EU-level obligation that runs through EUDAMED. National Competent Authorities — ANSM in France — verify the data and continue to hold market surveillance, vigilance, and, depending on device class and current transitional status, additional national-level duties. Understanding which obligations are EU-level, which are national, and how they interact is the whole point of this post.

The French registration framework at general level

France's medical device regulatory architecture has two layers that a founder has to hold in their head simultaneously.

The first layer is the EU-level MDR framework. Regulation (EU) 2017/745 is directly applicable in France, as it is in every Member State. Economic operators register under MDR Article 31, devices under MDR Article 29, and both registrations route through EUDAMED under MDR Article 33. The Competent Authority of the Member State where the economic operator is established verifies the actor data and issues the Single Registration Number. For a manufacturer established in France, that Competent Authority is ANSM. For a non-French manufacturer placing a device on the French market, the actor registration happens in the manufacturer's own Member State (or via an authorised representative established in the EU), and ANSM becomes relevant as the Competent Authority of the market where the device is sold.

The second layer is the French national framework. France has its own public health code provisions governing medical devices, and ANSM has historically administered a national notification regime for certain categories of device placed on the French market. This national regime predates the MDR and was designed for a pre-EUDAMED world where Member State databases were the only registration mechanism. As EUDAMED modules become functional and mandatory under MDR Article 34, national notification obligations are being rationalised against the EU system. The direction of travel is toward EUDAMED as the single register, but the timing and scope of that convergence is a matter of the French framework's transitional provisions rather than something a founder can assume on their own.

The practical rule for this post: the EU-level obligations under MDR Article 31 are fixed and can be stated with precision. The specific French national notification requirements change as ANSM and the French ministry adjust the national framework to the EUDAMED timeline, so founders should verify the current ANSM position for their specific device class before acting rather than rely on a static description.

What ANSM requires beyond EUDAMED

Even when a manufacturer's EUDAMED actor and device registration is clean, ANSM remains an active regulatory counterpart for devices on the French market. Three areas matter most.

Vigilance and incident reporting. Under MDR Articles 87 to 92, manufacturers report serious incidents and field safety corrective actions to the Competent Authority of the Member State where the incident occurred. If a serious incident involving your device happens in a French hospital, the report goes to ANSM — regardless of where your company is registered in EUDAMED. The EUDAMED vigilance module channels these reports once that module is fully operational, but ANSM remains the receiving authority for the French market.

Market surveillance. ANSM can inspect manufacturers, authorised representatives, importers, and distributors active on the French market under MDR Articles 93 to 100. That includes requesting the technical documentation, demanding samples, and taking enforcement action where non-compliance is found. A non-French manufacturer is not exempt from ANSM surveillance just because its EUDAMED home Member State is elsewhere.

National-level notification for specific device categories. Historically, France has operated national notification or communication obligations for particular categories of device placed on the French market. The scope, format, and timing of those obligations is set in the French framework and is the part founders should verify against the current ANSM position rather than against a blog post. The general framing founders should carry is: "There may be a French-specific notification on top of EUDAMED for my device class — I will check the current ANSM guidance before I place the device on the French market."

Notification versus authorisation

Founders new to European regulatory work sometimes conflate registration, notification, and authorisation. They are not the same thing and the distinction matters for France.

Registration is the act of putting your company and your device onto a register — EUDAMED at EU level, or a national database where one still exists. Registration does not grant permission to sell; it records the fact that the operator and device exist and are declared. The CE mark and the Notified Body certificate (where required) are what actually permit market placement under MDR.

Notification is a communication to the Competent Authority that a specific event or state has occurred — for example, that a device is being placed on the market in a specific country, that a clinical investigation is starting, or that a serious incident has happened. Notifications are generally informational rather than permission-granting.

Authorisation is a formal regulatory permission granted by the authority before an activity can take place — for example, authorisation of a clinical investigation under MDR Article 70, or authorisation of specific categories of higher-risk activity under national law.

For general medical device placement on the French market, the model under MDR is conformity assessment plus CE marking plus EUDAMED registration — not authorisation. ANSM's role is verification, surveillance, and vigilance, not pre-market authorisation of individual devices. Clinical investigations are a separate track with their own authorisation regime under MDR Articles 70 to 82 and the French implementing framework.

Language requirements for the French market

One ANSM-related topic that every founder selling into France eventually hits is language. MDR Annex I Chapter III requires that the information supplied with the device — label, instructions for use, safety information, implant card content where applicable — is in a language that can be easily understood by the intended user and, where relevant, in a language determined by the Member State where the device is made available.

France requires French. That is the core fact. The label, the IFU, the implant card text where applicable, and safety-relevant information must be available in French for a device placed on the French market. Professional-use devices in some contexts allow English for parts of the technical documentation, but patient-facing and user-facing material is French. This is not an ANSM-specific rule — it is the French application of the Annex I language rule combined with general French consumer and health law — but ANSM is the authority that will notice a non-compliant label if it comes up during surveillance or in a vigilance case.

The founder's move is to plan French translation and review before French launch, not after. A late French translation typically means a re-labelling project, stock that has to be re-worked, and a distributor relationship that starts with a corrective action instead of a sale.

The multi-market coordination angle

France is rarely a founder's first EU market. By the time ANSM becomes relevant, the founder has usually already done the EUDAMED actor registration through another Member State's Competent Authority, dealt with one or two other national frameworks, and built a vigilance contact list. ANSM should plug into that existing system rather than be treated as a separate project.

Three coordination principles help.

Single source of truth for data. The company name, address, SRN, PRRC under MDR Article 15, authorised representative (if applicable), Basic UDI-DI, and device classification must be identical across EUDAMED, every national notification, every label, and every distributor contract. Inconsistencies between what ANSM sees and what BfArM or BASG sees are how findings happen.

A single vigilance contact point. When a serious incident occurs in France, the report goes to ANSM. When it occurs in Germany, it goes to BfArM. Your internal vigilance process should route incident reports to the correct national authority automatically based on where the incident occurred — not manually, not as a one-off decision per case.

A current national-obligations register. Each Member State you sell into has its own evolving national framework running alongside EUDAMED. Keep a simple internal register — one row per country — of which national notifications, language requirements, and authority contacts apply. Update it quarterly. France gets one row. Germany gets one row. Do not try to hold this in your head.

Common mistakes

  • Assuming EUDAMED replaces all French national obligations today. MDR Article 34 governs the transition module by module; national duties continue in parallel where the corresponding EUDAMED module is not yet mandatory.
  • Treating ANSM as a database endpoint rather than as an active Competent Authority with vigilance and surveillance authority over your device on the French market.
  • Launching in France without French-language labelling and IFU, then discovering the gap when a French distributor or hospital procurement team asks for the French documentation.
  • Registering once in EUDAMED and never revisiting whether the information is still accurate. EUDAMED data and national data must both be kept current.
  • Copying another startup's "French registration" approach without checking whether their device class, risk class, and business model actually match yours.

The Subtract to Ship approach

The Subtract to Ship rule for ANSM is the same rule that applies to every national Competent Authority touchpoint. Do the MDR Article 31 EUDAMED work cleanly and completely — actor registration, PRRC data, authorised representative where applicable, SRN issued and current. That is the fixed EU-level foundation. Then, for France specifically, check the current ANSM position on national notification for your device class, confirm the French language obligations on label and IFU, and set up the vigilance routing so incidents on the French market reach ANSM within the MDR Article 87 timelines.

Everything else — speculative "French registration consultancy" sold as a separate engagement, elaborate national dossiers that duplicate EUDAMED data, bespoke French-specific quality documentation that is not required by the MDR or by current ANSM guidance — gets subtracted until a specific MDR article or a current, verified French national requirement justifies it. See the Subtract to Ship framework for MDR for the underlying methodology.

Reality Check — Where do you stand on ANSM registration?

  1. Do you know which Competent Authority verified or will verify your economic operator registration under MDR Article 31, and is that Competent Authority ANSM or another Member State's authority?
  2. Have you checked the current ANSM position on national notification for your specific device class, rather than assuming EUDAMED is sufficient?
  3. Is your label, IFU, and (where applicable) implant card text available in French before you place the device on the French market?
  4. Do you have a vigilance routing process that sends serious incidents on the French market to ANSM within the MDR Article 87 timelines?
  5. Is your PRRC under MDR Article 15 correctly named on the data that ANSM will see through EUDAMED or any national channel?
  6. If ANSM inspected your French distributor tomorrow, would the technical documentation, labels, and vigilance records match the EUDAMED record?

If more than two of these are unanswered, the French market is not yet a market you are ready to place a device on — it is a market you have a plan to enter.

Frequently Asked Questions

What is ANSM? ANSM is the Agence nationale de sécurité du médicament et des produits de santé, France's Competent Authority for medicinal products and medical devices. For medical devices under MDR, ANSM handles vigilance, market surveillance, and, where applicable, national-level notification for devices placed on the French market.

Do I need to register with ANSM if I already registered in EUDAMED? Economic operator registration under MDR Article 31 routes through EUDAMED and is verified by the Competent Authority of the Member State where the operator is established. Whether an additional French national notification applies to your specific device class depends on the current French framework, which is evolving as EUDAMED modules become mandatory. Check the current ANSM position for your device class before launching in France.

Is French translation of the label and IFU mandatory? For devices placed on the French market, user-facing material — label, IFU, patient-facing safety information, implant card content where applicable — must be available in French. This follows from MDR Annex I Chapter III and the French application of that requirement. Plan French translation before French launch, not after.

Does ANSM authorise my device before I can sell it in France? No. Under MDR, the route to the French market is conformity assessment, CE marking, and EUDAMED registration — not pre-market authorisation by ANSM. Clinical investigations are a separate track with their own authorisation regime under MDR Articles 70 to 82.

Where do I report a serious incident that happens in France? To ANSM, as the Competent Authority of the Member State where the incident occurred, under MDR Articles 87 to 92. Once the EUDAMED vigilance module is fully mandatory, reports flow through that module, but ANSM remains the receiving authority for the French market.

Sources

  1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Article 10 (general obligations of manufacturers), Article 15 (Person Responsible for Regulatory Compliance), Article 29 (registration of devices), Article 31 (registration of manufacturers, authorised representatives and importers), Article 33 (European database on medical devices — Eudamed), Article 34 (functioning of Eudamed), Articles 87-92 (vigilance), Articles 93-100 (market surveillance), Annex I Chapter III (labelling and instructions for use, including language). Official Journal L 117, 5.5.2017.
  2. Commission Implementing Regulation (EU) 2021/2078 of 26 November 2021 laying down rules for the application of Regulation (EU) 2017/745 as regards the European Database on Medical Devices (Eudamed). OJ L 426, 29.11.2021.
  3. ANSM — Agence nationale de sécurité du médicament et des produits de santé, official guidance on medical devices placed on the French market. (Readers should consult ANSM's current published guidance directly for the live status of French national notification obligations, language requirements, and vigilance contact procedures for their specific device class before acting. The French national framework is evolving alongside the EUDAMED transition under MDR Article 34 and the current-terms position should be verified case by case.)

This post sits in the EUDAMED, UDI and Registration cluster of the Subtract to Ship: MDR blog and links up to the EUDAMED pillar. Authored by Felix Lenhard and Tibor Zechmeister. The French national framework is the kind of topic that ages quickly — the MDR article anchors are stable, but the specific ANSM national notification position for any given device class should be verified against current ANSM guidance before launch.