CE marking
Support on the CE-marking procedure according to the class of the device (I, IIa, IIb, III), choice of the notified body, management of the technical documentation.
→ Health · Sub-expertise
European Regulation 2017/745 (MDR) has profoundly transformed the framework for medical devices: enhanced CE marking, vigilance, traceability, clinical requirements. We support manufacturers, importers and distributors in achieving compliance, managing incidents and defending against claims.
→ What we cover
Support on the CE-marking procedure according to the class of the device (I, IIa, IIb, III), choice of the notified body, management of the technical documentation.
Compliance with the clinical-evaluation requirements (CER) of the MDR, alignment with clinical investigations, management of equivalent clinical data.
Setting up the post-market surveillance system, PMS, PMCF, PSUR, alignment with device vigilance.
Management of device-vigilance incidents, declaration to the ANSM, organisation of FSCAs (field safety corrective actions), management of product recalls.
Compliance of distributors and importers with the MDR obligations (CE verification, traceability, vigilance), agreements with manufacturers.
Defence in the event of a claim regarding product safety, crisis management, alignment with insurers and any class actions.
→ Our approach
01
Analysis of the regulatory situation (device class, current marking), identification of the gaps with the MDR, compliance plan.
02
Updating of the technical documentation, internal organisation, choice of the notified body, management of audits.
03
Setting up the vigilance and post-market surveillance system, training of teams, management of incidents and FSCAs.
04
Defence in the event of a claim (product liability, ANSM litigation), crisis management, alignment with insurers.
→ Who we help
Transition plan for a class IIb device manufacturer from CE marking to the MDR regime: audit, updating of the documentation, choice of the notified body, training of teams.
Management of a field safety corrective action (FSCA) following a serious incident: ANSM declaration, communication to users, monitoring of the recall.
Defence of a manufacturer facing a class action by users challenging the safety of a device: analysis of the grievances, mobilisation of medical expertise, alignment with the insurer.
Drafting of a distribution agreement compliant with the MDR: distributor obligations, traceability, vigilance, respective responsibilities.
→ Q&A
The MDR (2017/745) replaced the MDD directive with enhanced requirements: more demanding clinical evaluation, traceability (UDI), post-market surveillance, transparency (Eudamed). Devices marked under the former regime must be progressively re-marked under the MDR according to specific timetables.
Field Safety Corrective Action: a corrective action in the field to reduce a risk associated with a marketed device. It may take several forms: withdrawal, modification, enhanced information. It is declared to the ANSM and to users, with rigorous follow-up.
Verification of the CE marking, compliance of the labelling, storage and transport conditions, traceability, transmission of vigilance information, cooperation with the authorities. Compliance is now directly monitored at distributors' level.
The manufacturer is responsible for the safety of the device, but the chain (importers, distributors, users) may also be held liable depending on the circumstances. Civil, administrative and criminal liability may apply. Professional and product liability insurance is essential.
→ Go further
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