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Publication of new Ordinances concerning the prior approval of the French authorities for the advertising of certain high risk medical devices in France

11 October 2012
On 19 December 2011, the Act on the reinforcement of the safety of medicinal and healthcare products was adopted in France[1]. This Act imposes new obligations on manufacturers concerning the advertising of medical devices. As a result of this Act and the related implementing Decrees No 2012-743 and No 2012-744 of 9 May 2012, the advertising of medical devices and in vitro diagnostic medical devices that pose an important risk to human health is subject to prior authorisation by the French National Agency for the Safety of Medicines and Health Products (ANSM). This authorisation is valid for five years.

A list of the medical devices and in vitro diagnostic medical devices concerned by this prior authorisation was drawn up by the French Ministry of Health and two Ordinances were published in the Official Journal on 3 October 2012.

The Ordinance concerning the advertising of medical devices

The advertising to the public of the following medical devices is subject to the prior authorisation of the ANSM:

  • Dermal fillers

The advertising to healthcare professionals of the following medical devices is subject to the prior authorisation of the ANSM:

  • Cardiology:  implantable heart defibrillators; implantable heart defibrillating leads; implantable heart stimulators and accessories; implantable heart stimulating leads; coronary stents
  • Repair Surgery:  breast implants; dermal fillers
  • Orthopaedics Traumatology:  ankle prostheses; knee prostheses; hip prostheses; shoulder prostheses
  • Ophthalmology:  intraocular lenses
  • Medical and Surgery Specialty:  laser generators for surgery
  • Neurology and Neurosurgery:  intracranial stents

 The Ordinance concerning the advertising of in vitro diagnostic medical devices

The advertising to the public of the following in vitro diagnostic medical devices is subject to the prior authorisation of the ANSM:

  • In vitro diagnostic medical devices for self-testing

The advertising to the healthcare professionals of the following in vitro diagnostic medical devices is subject to the prior authorisation of the ANSM:

  • Reagent and reagent products (including related calibrators and control materials) for determining the following blood groups: ABO system, rhesus (C, c, D, E, e) anti-Kell
  • Reagent and reagent products (including related calibrators and control materials) for the detection, confirmation and quantification in human specimens of markers of HIV infection (HIV 1 et 2), HTLV I and II and hepatitis B, C and D
  • Variant Creutzfeld-Jakob disease (vCJD) assays for blood screening, diagnosis and confirmation


[1]              LOI n° 2011-2012 du 29 décembre 2011 relative au renforcement de la sécurité sanitaire du médicament et des produits de santé, JORF n°0302, 30 December 2011, page 22667.

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