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France medical device registration resources

Research ANSM registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every France medical device resource.

5 free resources24/25 requirements coveredAug 2026 fees reviewed
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Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other France requirements.

Medical device regulation news

Follow recent Agence nationale de sécurité du médicament et des produits de santé (ANSM) policy, guidance, safety, and compliance updates.

AI medical device classifier

Describe your device and get a preliminary ANSM risk class with official rule references.

Government registration fees

Check the current ANSM position on device and IVD fees.

Registration timeline

Compare the statutory notified-body conformity assessment clock under Regulation (EU) 2026/977 with realistic CE marking times by device class.

Structured regulatory requirements

Explore all 35 source-linked facts →

24 of 25 research dimensions currently covered · 32 official sources · latest verification 2026-08-30

Market entry

D01

Authority & regime

Verified
Competent authority
ANSM (Agence nationale de sécurité du médicament et des produits de santé) is the competent authority for implementing Regulation (EU) 2017/745 in France and the responsible authority for n…
Market-surveillance authority split for consumer devices
The administrative authority in charge of competition and consumer affairs (DGCCRF, per Art. L522 1 Code de la consommation) also acts as competent authority for post market control and mar…
2 source-linked facts
Checked 2026-08-25
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D02

Legal basis & guidance

Verified
National MDR adaptation ordinance
Ordonnance n° 2022 582 of 20 April 2022 adapted French law to Regulation (EU) 2017/745: it rewrote CSP articles L5211 1 to L5211 3 2 (definitions, ANSM authority, derogations, declarations,…
2026 recast of the regulatory part of the CSP
Décret n° 2026 299 of 17 April 2026 (JORF 21 April 2026, in force 22 April 2026) recast the device provisions of the regulatory part of the Code de la santé publique: articles R5211 1 to R5…
2 source-linked facts
Checked 2026-08-25
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D03

Device definition & scope

Verified
National device definition (CSP)
CSP Art. L5211 1 defines dispositif médical and accessoire de dispositif médical in line with the MDR; software (logiciel) is expressly listed among device categories, Annex XVI products wi…
1 source-linked fact
Checked 2026-08-25
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D04

Classification rules

Verified
EU MDR classes I, Is, Im, Ir, IIa, IIb and III
Class I, Class Is, Class Im, Class Ir, Class IIa, Class IIb, Class III
1 maintained scheme
Checked 2026-08-26
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D05

Registration pathways

Verified
Market-access route and national registration surface
submissionSurface: CE conformity under MDR plus registration in EUDAMED (Actors and UDI/Devices modules mandatory since 28 May 2026; directive era/legacy devices must be registered before 2…
National list of custom-device market placers
ANSM publishes, and updates quarterly, a national list of the persons responsible for placing custom made medical devices on the French market who made the national declaration (name, addre…
3 source-linked facts
Checked 2026-08-25
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D06

Reliance & recognition

Verified
EU CE under MDR/IVDR — single market validity
target: geo:fra · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · loc…
1 source-linked fact
Checked 2026-08-30
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D07

Economic-operator roles

Verified
Operators subject to the national activity declaration
Three categories must declare their activities to ANSM: (1) any distributor making devices available on the French market (even incidentally), excluding resale to the public; (2) any manufa…
1 source-linked fact
Checked 2026-08-25
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D08

Establishment, import & distribution

Verified
Activity-declaration follow-up duties
Declarants must report any change to the initial declaration without delay, confirm the accuracy of the data one year after registration of the initial declaration and then every two years,…
1 source-linked fact
Checked 2026-08-25
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D09

Dossier requirements

Verified
Technical documentation (Annexes II and III)
The technical documentation required to demonstrate conformity with the general safety and performance requirements must be drawn up in accordance with Annex II to Regulation (EU) 2017/745…
1 source-linked fact
Checked 2026-08-29
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D10

Official forms & portals

Verified
National submission channels and forms
nationalDeclaration: ANSM form (docx) sent preferably electronically to communications.dm@ansm.sante.fr (or by registered mail) for L.5211 3 1 activity declarations, changes, cessation and…
Clinical-investigation submission channel pending EUDAMED
Until the EUDAMED clinical investigation module becomes functional (announced as not before 2028), clinical investigation applications for medical devices are submitted by email to ANSM, an…
2 source-linked facts
Checked 2026-08-25
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Submission & evidence

D11

Label, IFU & language

Verified
Documents that must be in French
The following must be drawn up in French: (1) labelling delivered to the end user or patient with the accompanying instructions for use and any other information on operation or use require…
1 source-linked fact
Checked 2026-08-25
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D12

QMS, audit & inspection

Verified
Manufacturer quality management system (Art. 10(9))
Manufacturers must establish, document, implement, maintain, keep up to date and continually improve a quality management system that ensures compliance with the Regulation in the most effe…
1 source-linked fact
Checked 2026-08-29
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D13

Standards, testing & ancillary approvals

Verified
MDR electrical safety in place of the Low Voltage Directive
Electrical safety
MDR electromagnetic compatibility in place of the EMC Directive
EMC
RED conformity under ANFR market surveillance
Wireless / radio
7 maintained overlays
Checked 2026-08-29
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D14

Fees

Verified
Medical-device procedures (registrations, notifications, certificates)
EUR 0
1 maintained fee line · 2 related facts
Checked 2026-08-25
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D15

Review clocks

Unresolved
Class I · Self-declaration (no notified body)
0 days
1 maintained pathway · 2 related facts
Checked 2026-08-29
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D16

Approval validity & renewal

Verified
Certificate validity and renewal (Art. 56(2))
EU certificates issued by notified bodies are valid for the period they indicate, which may not exceed five years. On application by the manufacturer the validity of the certificate may be…
1 source-linked fact
Checked 2026-08-29
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Lifecycle & post-market

D17

Change control

Verified
Substantial modifications to clinical investigations
Substantial modifications (modifications substantielles) to an authorised clinical investigation follow a dedicated CPP procedure (Arts. R1125 11 to R1125 13 CSP) and CPP silence at the end…
1 source-linked fact
Checked 2026-08-25
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D18

UDI, listing & traceability

Verified
EUDAMED modules mandatory in France
Use of the first four EUDAMED modules (Actors; UDI/Devices; Notified bodies and certificates; Market surveillance) is mandatory since 28 May 2026; devices marketed under directives 93/42/CE…
1 source-linked fact
Checked 2026-08-25
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D19

Clinical investigation & performance

Verified
National clinical-investigation route
Clinical investigations to demonstrate conformity of a device (or otherwise requiring authorisation, e.g. categories 2c/d and 4 of R1125 1) may start only after both a favourable CPP opinio…
1 source-linked fact
Checked 2026-08-25
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D20

Special access & derogation

Verified
CE-marking derogation route (MDR Art. 59)
ANSM may grant, in exceptional circumstances and in the public health interest, individual derogations (supply to a named establishment/professional) or global derogations (supply to any he…
1 source-linked fact
Checked 2026-08-25
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D21

Manufacturer PMS

Verified
Trend and periodic summary report channel to ANSM
Trend reports and periodic summary reports (rapports de synthèse périodique) are declared to ANSM by email at materiovigilance@ansm.sante.fr; the manufacturer incident report format MIR 7.3…
1 source-linked fact
Checked 2026-08-25
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D22

Vigilance & incident reporting

Verified
Materiovigilance correspondent for manufacturers
Any manufacturer placing devices on the French market, or its authorised representative (mandataire), must designate a materiovigilance correspondent established in France or, failing that,…
Materiovigilance correspondent for service providers and distributors
Service providers (prestataires de services) and distributors of equipment mentioned in Art. L5232 3 CSP must also designate a materiovigilance correspondent and notify it to ANSM an extens…
5 source-linked facts
Checked 2026-08-25
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D23

Recall, FSCA & market surveillance

Verified
FSCA reporting to ANSM
Field safety corrective actions (actions correctives de sécurité) must be declared to ANSM in PDF and XML at materiovigilance@ansm.sante.fr; ANSM can order manufacturers to take corrective…
1 source-linked fact
Checked 2026-08-25
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D24

Advertising, claims & promotion

Verified
Advertising to the public - content rules
Advertising to the public for a medical device must include the device name/commercial reference, an express invitation to read the instructions, and a prudence message proportionate to ris…
Prior ANSM approval for certain device advertising
Advertising for certain medical devices presenting a significant risk to human health (list fixed by ministerial order) and for IVDs liable to cause a serious health risk is subject to prio…
2 source-linked facts
Checked 2026-08-25
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D25

Submission communications & appeal

Verified
Recourse channel for notified-body matters
ANSM is the responsible authority for notified bodies under Article 35 of Regulations (EU) 2017/745 and 2017/746, handling their evaluation, designation, re assessment and joint assessments…
1 source-linked fact
Checked 2026-08-25
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Government fees

Full fee schedule (1 lines) →

ANSM registration fees in EUR · reviewed 2026-08-25

Fee lineAmountProvenance
Medical-device procedures (registrations, notifications, certificates)EUR 0Verified

Registration timeline

Full registration timeline →

French National Agency for the Safety of Medicines and Health Products (ANSM) review clocks and planning ranges · 4-class (I, IIa, IIb, III) — EU MDR classification

Class / pathwayReview clockPlanning totalProvenance
Class I(Self-declaration (no notified body))0 days6-9 monthsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(0 days)
  5. 5Registration Approval(1-2 weeks)
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France market-launch workpaper

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France dossier reuse and delta

Compare an existing authorization and evidence set against ANSM administrative, testing, labeling, and dossier needs.

France change notification workpaper

Map a product or manufacturing change to ANSM evidence, notification, timing, and implementation questions.

France regulatory change impact

Assess a current ANSM update against one product and turn it into an owner-ready action workpaper.

France cybersecurity evidence review

Review connected-device architecture, risks, SBOM, testing, lifecycle controls, and market-specific questions for France (ANSM).

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