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Does my medical device need RED conformity under ANFR market surveillance in France?

Describe your device to check whether RED conformity under ANFR market surveillance may apply, why, what facts are missing, and which official source to review.

7 maintained routes10 official source links

Preliminary applicability · country-specific scope

What you receive

Not just a yes or no

A route-by-route answer. Separate product certificates, dossier evidence, import documents, and facility licences stay separate.

Trigger reasoning. See which product facts matter and which missing facts prevent a reliable conclusion.

Official starting points. Open the regulator or government sources behind the maintained country matrix.

Maintained country rule

What this RED conformity under ANFR market surveillance check is screening

Checks Wi-Fi, Bluetooth, cellular, NFC, RFID, UWB, telemetry, and proprietary radio approval. Applies when the product, feature, component, or use is in scope.

Requirement family: Radio and spectrum approval
Regulatory object: radio equipment
Maintained rule status: mandatory if feature
Useful product facts: Radio technologies, bands, power, antenna, module model, approval IDs, and host integration changes.

ANFR, which is itself the market surveillance authority for radio equipment in France, publishes that the RED is transposed by ordonnance n° 2016-493 of 21 April 2016 and décret n° 2017-599 of 21 April 2017, amending the Code des postes et des communications électroniques. Sourcing limit worth carrying: Légifrance answers HTTP 403 behind a bot challenge to both direct requests and extraction services, so the CPCE articles and the transposing texts themselves were not read and no explicit French negative on national type approval is claimed here.

How to read the answer

Classification is only the first layer

A device may have one medical risk class and still trigger separate radio, electrical, measurement, radiation, environmental, import, or installation requirements. The checker keeps each regulatory object separate.

Product approval

A certificate or approval attached to the finished product, component, or radio host.

Dossier or import evidence

Testing can belong inside the medical dossier, while some documents apply to each shipment.

Site or operator licence

Radiation, installation, use, or measurement controls may apply to a facility or operator.

Country-specific scope

Other France routes to check

Check every France route →

Electrical safety

MDR electrical safety in place of the Low Voltage Directive

Evidence is normally handled inside the medical-device registration route.

EMC

MDR electromagnetic compatibility in place of the EMC Directive

Evidence is normally handled inside the medical-device registration route.

Environmental / battery

Code de l'environnement substance restriction (RoHS)

Evidence may be required, but the matrix does not identify a generic separate certificate.

Environmental / battery

SYDEREP registration and identifiant unique

Applies when the product, feature, component, or use is in scope.

Environmental / battery

Battery producer responsibility through an approved éco-organisme

Applies when the product, feature, component, or use is in scope.

Radiation

ANSM mandatory quality control in service

Applies to the facility, operator, or installation rather than only the product.

Official starting points

Use these authority pages to confirm current scope, technical rules, application routes, and transition dates. A linked source does not turn a preliminary result into an authority decision.

ANFR (Agence nationale des fréquences)

RED transposition by ordonnance 2016-493 and décret 2017-599, and ANFR market surveillance of radio equipment

About this checker

A preliminary tool, not a regulatory determination

Describe the complete product — radio, power, measurement, radiation, battery, materials, accessories, intended use, import route, and existing approvals. The free checker maps those facts to the maintained France scheme matrix and links each route to its official source.

Use the result to identify questions and official sources. Final scope can depend on exact models, modules, bands, components, claims, HS codes, import structure, installation site, and current authority interpretation.

Is this the same as medical device classification in France?: No. Risk classification determines the main medical-device pathway. This checker runs after classification and looks for additional product certificates, dossier evidence, import documents, and facility or operator licences.
Does “no separate certificate” mean no testing is required?: No. Safety, EMC, performance, or other evidence can still be required inside the medical-device dossier even when there is no separate national product certificate.
Is the result an official regulatory determination?: No. It is a preliminary applicability assessment. Review the linked official source and confirm the final route with the relevant authority, certification body, importer, or regulatory professional.