ANSM orders Montagny lab to fix custom medical device failures
France's medicines and health products agency, ANSM, has ordered Laboratoire Dumont et Montet, a company in Montagny (Rhône), to correct serious compliance failures in how it makes custom-made medical devices. The order follows a June 2026 inspection and the company's September 2026 reply, which did not satisfactorily resolve the problems. Deadlines range from one month for raw-material documents to six months for traceability and documentation.
What does it mean?
The lab makes medical devices built to order for individual patients, and regulators found its record-keeping and quality checks were not good enough. It now has to fix these problems within set deadlines, from one month to six months. If it does not, it faces further action from the regulator.
Who is affected?
Patients who use the lab's custom-made medical devices, and the company's staff who handle production records and materials.