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ANSM orders custom-made device maker Laboratoire Dumont et Montet to fix traceability and release failings

🇫🇷 ANSM · Fri 30 Oct 2026

Following a June inspection at its Montagny site, France's regulator has set deadlines of one to six months for correcting five unresolved MDR non-conformities.

France's medicines and health products agency ANSM has issued injunction no. 2026-DM-044-INJ against Laboratoire Dumont et Montet, concerning its establishment at 145 route de Millery in Montagny (Rhône). The decision is dated 28 October 2026 and was published on 30 October.

The measure follows an inspection carried out from 8 to 10 June 2026, which found significant non-conformities. ANSM notified them in a pre-injunction letter on 31 July 2026. After reviewing the company's reply of 4 September 2026, the agency concluded that five issues had not been satisfactorily resolved. All relate to custom-made medical devices under Regulation (EU) 2017/745 (MDR).

The unresolved findings cover: insufficient traceability of manufacturing data and uncontrolled backup of that data, including the Annex XIII statement; missing documentation to assess and maintain conformity with requirements; inadequate control of the quality and biocompatibility of raw materials; shortcomings in the system for releasing custom-made devices; and poor management of storage conditions and expiry dates for raw materials and process products.

ANSM has set staggered deadlines. Within one month at the latest, and sooner if possible, the company must hold all documents demonstrating the quality and biocompatibility of raw materials used in custom-made devices placed on the market. Within three months it must establish and document a reliable release system and bring storage conditions and expiry dates under control. Within six months it must put in place a reliable traceability and secure backup system with MDR-compliant retention, and draw up the Annex XIII section 2 documentation together with measures to maintain compliance.

The injunction cites articles L. 5311-1, L. 5312-4-3 and L. 5313-1 of the French public health code. It is signed by Linda Gallais, deputy director of the inspection directorate. The source does not describe the devices concerned or any further sanctions.

What it means for your team

  • Manufacturers of custom-made devices should check that production data traceability, secure backup and retention meet MDR Annex XIII and Annex IX requirements.
  • Raw-material evidence, including regulatory documents or test results on biocompatibility, was a focus, and ANSM gave the shortest deadline (one month) for this item.
  • Release procedures and control of storage conditions and expiry dates for materials and process products are inspection-relevant and were given three months to correct.
  • Replies to pre-injunction letters need to resolve findings fully: here, ANSM judged the company's response insufficient before issuing the injunction.

Official source: ANSM ↗

Article written by VigiEye from the official source (ANSM). AI-assisted; check the source before acting.

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