EUDAMED: Key Information for Medical Devices and IVDs in France (ANSM Overview)

What is EUDAMED?

EUDAMED is the European database on medical devices established under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). It aims to centralize information on devices, economic operators, certificates, vigilance, and clinical investigations to enhance transparency, traceability, and coordination across the EU, including France. The database became partially operational in December 2020, with phased mandatory use. Quelques informations sur EUDAMED - ANSM

Mandatory Modules and Registration

Actor Registration

• Manufacturers, authorised representatives, importers, and distributors must register in EUDAMED (Actor module) and obtain a Single Registration Number (SRN).
• In France, registration is mandatory since 26 May 2021 (MDR) and 26 May 2022 (IVDR) for relevant actors.
• SRN is required for most other EUDAMED submissions.

Device Registration (UDI/Device module)

• Devices must be registered with a Unique Device Identification (UDI-DI) and Basic UDI-DI.
• Core data elements include intended purpose, classification, and certificates.
• UDI carrier must appear on label/packaging; deadlines vary by risk class.
• Legacy devices under transitional provisions are progressively registered as certificates expire or new conformity assessments occur.

Vigilance and Post-Market Surveillance

• Serious incidents and field safety corrective actions must be reported via the Vigilance module.
• Periodic Summary Reports (PSR) and Trend Reports submitted electronically.
• Manufacturer Incident Report (MIR) form replaced by EUDAMED structured reporting.
• In France, vigilance reports continue to be handled by ANSM with parallel EUDAMED submission where required.

Clinical Investigations and Performance Studies

• Clinical investigation plans, serious adverse events, and results registered in the Clinical Investigations/Performance Studies module.
• For legacy devices, transitional provisions allow continued use of national procedures in some cases during MDR/IVDR transition.

Certificates and Notified Bodies

• Certificates issued by notified bodies are uploaded to EUDAMED.
• Suspension, restriction, or withdrawal notifications are publicly visible (subject to confidentiality rules).
• French notified bodies comply with EUDAMED upload obligations.

Transitional Arrangements

• Until full mandatory use of all modules (expected after complete rollout and Commission notice), certain national systems remain in place in France.
• Legacy devices (MDD/AIMDD/IVDD certified) follow transitional provisions for registration and vigilance.
• Voluntary early registration encouraged to prepare for full mandatory phase.

Practical Advice for Operators in France

• Register as actor and obtain SRN via the EUDAMED portal before other obligations.
• Implement UDI system and ensure correct labelling.
• Use ANSM guidance and EU MDCG documents for detailed requirements.
• Monitor ANSM updates for France-specific interpretations or deadlines.
• For legacy devices, plan migration to MDR/IVDR compliance to avoid supply interruptions.

EUDAMED strengthens post-market surveillance and transparency for medical devices and IVDs across the EU, with France applying the rules directly as an EU Member State. Quelques informations sur EUDAMED - ANSM