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ANSM reports on laser and IPL hair and tattoo removal devices as MDR deadlines near

🇫🇷 ANSM · Tue 03 Nov 2026

France's regulator reviewed 29 manufacturers and distributors of professional aesthetic laser and pulsed-light equipment and found that only one had completed MDR certification by summer 2025.

ANSM has published the results of a market surveillance exercise on professional laser and intense pulsed light equipment used for hair removal and tattoo removal for aesthetic purposes. The agency also used the publication, dated 3 November 2026, to remind companies of their obligations under the EU Medical Devices Regulation (MDR).

The MDR has applied since 22 June 2023 to certain products with no medical purpose, grouped in six categories listed in Annex XVI, with common specifications setting out the requirements. ANSM notes that the scope includes laser and pulsed-light equipment for hair removal, tattoo removal and other skin treatments. Beauty professionals in France have been allowed to use hair removal equipment since 2024.

The agency began its controls at the end of 2024, sending information requests to 29 manufacturers and distributors. The requests covered regulatory status, CE marking, steps taken towards MDR compliance and available vigilance data. Eighteen companies replied, which let ANSM examine about 50 models. Some firms hold equipment already certified under the former Directive 93/42/EEC and meet the conditions for transitional provisions. Others have started the move to the MDR, and some equipment still falls under general product safety rules. By summer 2025, only one of the contacted companies had completed its transition and obtained MDR certification.

ANSM also found that operators' knowledge of MDR requirements remains uneven, particularly on the clinical data needed and on mandatory post-market surveillance. It has reminded the companies of their duties and is continuing to brief learned societies, unions and professional organisations in the sector.

Transitional arrangements allow continued marketing until 31 December 2028 or 31 December 2029, depending on factors such as device class and whether the manufacturer must carry out a clinical investigation. Until 31 December 2028 applies if no clinical investigation is planned and the manufacturer has a written agreement with a notified body by 1 January 2027. Until 31 December 2029 applies if the manufacturer has submitted a clinical investigation application and has a written agreement with a notified body by 1 January 2028.

What it means for your team

  • Manufacturers and distributors of Annex XVI aesthetic laser and IPL equipment, including products previously under general product safety rules, should continue MDR conformity work.
  • Check which transitional route applies: the 2028 deadline needs a notified body agreement by 1 January 2027, and the 2029 deadline needs a clinical investigation application and an agreement by 1 January 2028.
  • Clinical data planning and post-market surveillance were highlighted as areas of weak understanding, so teams should review these first.
  • Expect continued ANSM outreach to professional bodies, and possibly further scrutiny of companies that did not respond to the 2024 requests.

Official source: ANSM ↗

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

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