The ANSM — the French National Agency for the Safety of Medicines and Health Products — is the French competent authority for the surveillance of medical devices. Since the MDR became applicable in May 2021, it has adapted its surveillance activities to take the new regulatory framework into account. The first thematic campaigns and the published signals outline priorities that manufacturers have every interest in knowing.
The role of the ANSM in the MDR system
The ANSM performs a dual mission under the MDR. Upstream, it receives and processes vigilance reports from manufacturers established in France or whose devices are placed on the French market. Downstream, it carries out market surveillance activities to verify that the devices placed on the market comply with the MDR requirements.
It is also the national point of contact for regulatory questions on medical devices in France: qualification, classification, opinions on borderline cases.
The surveillance priorities revealed by the first actions
Several signals make it possible to identify the ANSM’s priorities in its post-MDR surveillance.
Class I devices. The first thematic surveillance campaigns targeted categories of self-certified devices whose documentary compliance (technical documentation, declaration of conformity) was suspected of being insufficient. Class I manufacturers are not safe from inspections — self-certification does not exempt them from the technical documentation.
Labelling and the IFU. The compliance of labelling with the requirements of Section 23 of Annex I is a recurring surveillance theme. Labelling non-conformities (missing particulars, incorrect symbols, IFU not available in French) have been identified during market inspections.
Vigilance. The ANSM verifies that manufacturers comply with their obligations to report serious incidents within the MDR time limits. Failure to meet the time limits is a traceable and documented deviation.
What manufacturers should take away from this
The ANSM does not limit its surveillance to devices that are the subject of reports. It carries out proactive inspections on categories of devices according to its own prioritisation criteria. A manufacturer that has never had a reported incident is not, for that reason, safe from an inspection.
The publication by the ANSM, on its official website, of decisions to withdraw or suspend the placing on the market is a useful source of information on the types of non-conformities actually identified.
Source: ANSM — ansm.sante.fr