ANSM · Europe

France medical device regulatory resources

Every France dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

5 free resources23/25 topics with recordsAug 2026 fees reviewed

Run the classification agent

Everything we track for France

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.

Changes after registration

Explore questions and sources →

Common questions about changing a registered medical device in France. Each question separates published rules from details still awaiting verification.

Does changing a device brand name or logo require an update? →Source-linked rules available
How do I update a manufacturer's name without changing the legal entity? →Source-linked rules available
What changes when the manufacturer's office address changes? →Source-linked rules available
Does a catalogue or reference code change affect registration or UDI? →Source-linked rules available
Can a registration transfer to a different legal entity? →Source-linked rules available
Can several changes be filed together? →Source-linked rules available

Structured regulatory requirements

Explore all 51 source-linked facts →

23 of 25 research dimensions currently covered · 43 official sources · latest verification 2026-10-21

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

Open details →

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

Open details →

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

Open details →

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

Open details →

D05

Registration pathways

Verified

Update the affected actor record: Manufacturers, authorised representatives and importers register under their actual role before placing devices on the market, subject to the regulation’s scope. Changed registered actor da…
Update only the actual French national activity declaration: French national activity declarations apply to distributors excluding sale to the public and the specified sterilisers. Under the director prescribed procedure, declarants report changes wi…

6 source-linked facts

Checked 2026-10-21

Open details →

D06

Reliance & recognition

Verified

NMPA certificate does not replace EU conformity assessment: statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and proce…
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…

2 source-linked facts

Checked 2026-09-15

Open details →

D07

Economic-operator roles

Verified

Document a real authorised-representative handover: If the authorised representative changes, the manufacturer, incoming representative and, where practicable, outgoing representative agree the end/start of mandates, last date for the former…
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…

2 source-linked facts

Checked 2026-10-21

Open details →

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

Open details →

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

Open details →

D10

Official forms & portals

Verified

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…
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…

4 source-linked facts

Checked 2026-10-21

Open details →

Submission & evidence

D11

Label, IFU & language

Verified

Align the changed identity in labels and declaration: For devices conforming under MDR or IVDR, labels identify the device name/trade name and the manufacturer’s registered name or trademark and business address, with the non EU manufacturer’s…
French IVD labelling and declaration particulars: For IVDs/accessories placed on the market or put into service in France, the end user/patient label, accompanying IFU, other IVDR Annex I section 20 operation/use information, EU declaratio…

3 source-linked facts

Checked 2026-10-21

Open details →

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

Open details →

D13

Standards, testing & ancillary approvals

Unresolved

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

Open details →

D14

Fees

Verified

Medical-device procedures (registrations, notifications, certificates): EUR 0

1 maintained fee line · 3 related facts

Checked 2026-10-21

Open details →

D15

Review clocks

Unresolved

Class I · Self-declaration (no notified body): 0 days

1 maintained pathway · 2 related facts

Checked 2026-08-29

Open details →

D16

Approval validity & renewal

Verified

Separate already lawfully placed legacy units: Qualifying devices lawfully placed under the relevant directive or legacy transition may continue to be made available or put into service. Further legacy placing is subject to the actual c…
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…

2 source-linked facts

Checked 2026-10-21

Open details →

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…
Assess a legacy IVD change under its actual transition: MDCG 2022 6 generally treats organisational name/address/legal form changes, including merger/acquisition examples, as changes not concerning design/intended purpose. The manufacturer docum…

5 source-linked facts

Checked 2026-10-21

Open details →

D18

UDI, listing & traceability

Verified

Assess the actual REF, model and UDI consequence: A new UDI DI is required for a change that could cause device misidentification or ambiguity in traceability, including a changed device name/trade name or version/model. New UDI data must…
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…

2 source-linked facts

Checked 2026-10-21

Open details →

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

Open details →

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

Open details →

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

Open details →

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

Open details →

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

Open details →

D24

Advertising, claims & promotion

Verified

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…
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…

2 source-linked facts

Checked 2026-08-25

Open details →

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

Open details →

Government fees

Full fee schedule (1 lines) →

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

Fee line	Amount	Provenance
Medical-device procedures (registrations, notifications, certificates)	EUR 0	Verified

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 / pathway	Review clock	Planning total	Provenance
Class I(Self-declaration (no notified body)) MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock Elapsed time is Eudamed actor and device registration, which has no guaranteed processing time, plus any national registration duty	0 days	6-9 months	Verified

Class / pathway

Review clock

Planning total

Provenance

Class I(Self-declaration (no notified body))

MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock

Elapsed time is Eudamed actor and device registration, which has no guaranteed processing time, plus any national registration duty

0 days

6-9 months

Verified