A sales brochure, a product page, a congress panel, a sponsored video: as soon as material is designed to promote the use of a medical device, it counts as advertising under the French Public Health Code. The mandatory statements for medical device advertising then apply, whether the material addresses the public or healthcare professionals. They are rarely what makes a campaign worth reading, but they are often the first thing an inspection picks up.

What the French Public Health Code treats as advertising

Article L.5213-1 defines medical device advertising as any form of information, including canvassing, prospecting or inducement, intended to promote the prescription, supply, sale or use of those devices. The same article excludes labelling and instructions for use, correspondence needed to answer a specific question about a particular device, and vigilance information. A document does not escape the scope because it is titled “information”. Its purpose decides.

Article L.5213-2 sets the substantive requirements. Advertising must present the device objectively and encourage its proper use. It must not be misleading and must not create a public health risk.

The mandatory statements for medical device advertising aimed at the public

Article R.5213-1 sets the list that applies to the general public. The material must carry:

  • an immediately obvious advertising character, and identification of the product as a medical device;
  • the date it was drawn up or last amended;
  • the name of the device or its commercial reference;
  • the intended purpose as defined by the manufacturer;
  • the name of the manufacturer or of its authorised representative;
  • the information essential to proper use;
  • an express invitation to read carefully the instructions in the leaflet or on the labelling;
  • a caution message matched to the risk the device presents;
  • the French statement “Ce dispositif médical est un produit de santé réglementé qui porte, au titre de cette réglementation, le marquage CE”, stating that the device is a regulated health product bearing the CE marking on that basis;
  • the internal reference number, where one exists.

The same article forbids any mention of reimbursement by statutory health insurance. It also bans suggesting that a medical consultation is unnecessary, claiming that use of the device carries no undesirable effect, addressing children mainly, using testimonials from public figures (tolerated for class I and IIa devices) or promising results of a miraculous nature.

One upstream rule governs everything else. Article L.5213-3 prohibits advertising to the public for devices reimbursed by statutory health insurance, except those on a list set by ministerial order. Check that before writing a single line: a flawlessly drafted piece about a reimbursed class IIb device is still barred from the public.

What professional material has to include

Article R.5213-2 covers material addressed to healthcare professionals. Adapted to its recipients and dated, it must include:

  • the name of the device or its commercial reference;
  • its intended purpose, characteristics and the performance claimed;
  • the class of the device;
  • the name of the notified body involved in the conformity assessment, where there is one;
  • the name of the manufacturer or of its authorised representative;
  • the information essential to proper use;
  • an express invitation to read carefully the instructions accompanying the device;
  • the reimbursement status and, where relevant, the prescription conditions;
  • the internal reference number, where one exists.

Article R.5213-3 adds a requirement on the quality of the information: accurate, up to date, verifiable and complete enough for the professional to form their own view of the characteristics and performance of the device. Quotations and scientific references must be reproduced faithfully, with their exact source stated. Every written statement must remain perfectly legible, and that is often where material fails: the statement is there, in tiny type, on the back of the document.

Class, notified body and CE marking: what Regulation 2017/745 adds

Regulation (EU) 2017/745 also governs what may be claimed. Its Article 7 prohibits any text, trade mark or image liable to mislead the user or the patient regarding the intended purpose, safety or performance: ascribing functions the device does not have, failing to inform of a likely risk, or suggesting uses other than those for which the conformity assessment was carried out. That last case is the most common: the material widens the intended purpose beyond what the technical documentation supports, often through one adjective added late.

Article 20 completes the picture. Where a notified body has been involved, the CE marking is followed by that body's identification number, and the number must also appear in any promotional material stating that the device meets the requirements for CE marking. A strapline such as “CE marked device” without the four digit number is therefore incomplete.

ANSM prior authorisation: who is concerned

Article L.5213-4 makes advertising for certain devices and accessories that present a significant risk to human health subject to prior authorisation by the ANSM, the list being set by the order of 24 September 2012, as amended in 2013. For the public, dermal filler products are covered. For healthcare professionals, the ANSM cites implantable cardiac devices, coronary stents, breast implants, joint prostheses and surgical lasers among others. The agency has two months from receipt of a complete application to authorise or issue a reasoned refusal; with no answer, the application is deemed accepted. The authorisation runs for five years, subject to the validity of the CE marking certificate.

Everything else falls under retrospective control. No filing does not mean no scrutiny: Article L.5213-5 allows the ANSM to give formal notice to the party responsible to withdraw the advertising or bring it into line, with a periodic penalty payment if needed.

IVDs sit in a separate chapter

In vitro diagnostic medical devices are covered not by the L.5213 articles but by Articles L.5223-1 to L.5223-5 and R.5223-1 onwards, built on the same pattern. Prior authorisation here targets public advertising for self testing devices and, for professionals, sensitive reagents such as blood grouping reagents and those used to detect hepatitis and HIV markers. Regulation (EU) 2017/746 restates the same prohibition on misleading claims in its Article 7. Do not reuse the medical device checklist as it stands.

In practice

The hard part is not knowing these statements, but holding them across a living estate of material: one product range, several classes, several countries, versions that multiply faster than they are corrected. Useful control is mechanical and repeatable: an intended purpose identical to the leaflet, a notified body number wherever CE marking is cited, class and reimbursement status on professional material, a legible regulatory statement on public material, and a record of who approved what.

That is the work we support with EryonOne, where the ANSM doctrine on medical devices and the French Public Health Code are among the regulatory frameworks available for review, each finding quoting both the passage in the material and the reference text. Your charters and claims matrices can be added as requirements specific to your organisation. The report remains working material rather than an approval: the decision to release belongs to your regulatory affairs team.

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