An ANSM inspection is a market surveillance exercise conducted by a national competent authority. It is fundamentally different from a notified body audit on several important points. Confusing it with an NB audit — and preparing for it the same way — is a mistake.
The fundamental differences between an ANSM inspection and an NB audit
The objective. An NB audit aims to verify the manufacturer’s regulatory compliance and to issue or maintain a certificate. An ANSM inspection aims to exercise market surveillance — to ensure that the devices placed on the market are compliant and do not present a risk to public health. In the event of serious non-compliance, ANSM can take public health enforcement measures: suspension of placing on the market, withdrawal, public warning.
The legal framework. An NB audit is a contractual relationship. An ANSM inspection is a regulatory administrative procedure. The ANSM inspector has investigative powers that the NB auditor does not have: access to all premises and documents, the right to seize samples, and the ability to conduct interviews.
The scope. An NB audit covers the QMS and the technical documentation of certified devices. An ANSM inspection can cover any aspect of the manufacturer’s activity: device compliance, vigilance, labelling, advertising, subcontracting agreements.
What ANSM inspections target in practice
ANSM inspections can be scheduled (included in the annual surveillance programme) or triggered by an event: the reporting of an incident, a complaint from a healthcare professional, an alert from European market surveillance.
The most frequently inspected topics: QMS compliance with MDR requirements, device traceability, compliance with vigilance obligations (reporting within deadlines, documented FSCA), and compliance of labelling and IFU.
The manufacturer’s rights and obligations
The manufacturer has an obligation to facilitate the inspection: access to premises, provision of the requested documents, and designation of a point of contact. It has the right to be assisted by legal counsel or a consultant during the inspection. It has the right to receive the inspection report and to submit comments before it is finalised.
How to prepare your team without panicking
The best preparation for an ANSM inspection is a QMS that genuinely works. The list of documents to have immediately available: the technical file of the devices concerned (or the NB certificate for certified devices), the vigilance records for the last two years, the complaint records and their handling, ongoing and closed CAPAs, and the contracts with critical subcontractors.