Advertising for medical devices (MDs / IVDMDs)
Since 1 January 2013, regulations on advertising have applied not only to pharmaceutical companies, but also to manufacturers of medical devices (MDs) and in vitro diagnostic medical devices (IVDMDs). The latter are now required to comply with a number of requirements governing their promotional materials intended both for the general public and for healthcare professionals. However, these provisions are not limited solely to manufacturers. Various operators including representatives, importers and distributors are also concerned.
What is advertising?
Advertising for medical devices is defined as any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or use of these devices […] (Article L.5213-1 of the French Public Health Code). Examples of advertising: Brochures, TV films, exhibition stand banners, radio commercials, Internet advertising, etc. What are the applicable obligations?
In general, advertising should be objective. It should always be related to performance and compliance with essential requirements and should encourage appropriate use of the device. The information provided should not be misleading or pose a risk to public health. Advertising should also be tailored to the target audience. There are two categories of advertising:
Advertising to the general public
Advertising to healthcare professionals
Each type of advertising shall contain mandatory information including the name of the product, the name of the manufacturer, an invitation to read the instructions for use, etc. In addition, some other rules must also be followed, depending on the target audience. The ANSM has laid down all the recommendations to be adopted. It should be noted that the advertising of reimbursed Class IIb and III medical devices to the general public is prohibited.
Any Internet communication should also be controlled, regardless of the class of the device.
Is authorisation from the ANSM required?
The ANSM can indeed monitor promotional materials. The procedures for monitoring advertising vary depending on the target (general public or healthcare professionals) and the type of medical device. According to the criteria set out in the following table, advertising may require monitoring and prior authorisation from the ANSM:
MDs subject to authorisation: * implantable cardioverter-defibrillators, implantable cardioverter-defibrillator leads, implantable pacemakers and accessories, implantable pacing leads, coronary stents, intracranial stents, breast implants, filling products for skin depressions, ankle, hip & shoulder prosthetics, intraocular lenses, surgical laser generators. IVDMDs subject to authorisation: Reagents and reagent products, including associated calibration and control materials, for the determination of the following blood groups: ABO, Rh (C, c, D, E, e) and Kell systems; reagents and reagent products, including associated calibration and control materials, for the detection, confirmation and quantification in human specimens of markers of HIV (HIV 1 and 2), HTLV I and II and hepatitis B, C and D infection; in vitro diagnostic medical devices for the detection, diagnosis and confirmation of variant Creutzfeldt-Jakob disease.
For devices requiring prior authorisation, application requests can be submitted throughout the year. They are processed within two months from receipt of the complete dossier. Authorisation is valid for five years subject to the validity of the CE certificate.
What about Regulation (EU) 2017/745 and Regulation (EU) 2017/746?
With the entry into force of Regulation (EU) 2017/745 and Regulation (EU) 2017/746, all the activities of various economic operators were reviewed and new requirements were introduced. Advertising was no exception. Article 7 on “Claims” sets out advertising obligations. Although it does not specifically introduce any new or additional requirements as compared with the French Public Health Code and the ANSM’s recommendations on the content of promotional materials, this article provides for the establishment of an “advertising” procedure as part of the QMSs of manufacturers. This point is partly raised in the Ministerial Order of 4 March 2022 establishing a quality charter for the professional practices of persons in charge of the presentation or promotion of or the provision of information about medical devices for individual use, health products other than medicinal products, and any associated services.
Why should you turn to EFOR-CVO for assistance?
Our regulatory affairs experts will be pleased to offer you support in line with your needs for all of the following topics (non-exhaustive list):
- Assistance to help you identify your obligations depending on your situation,
- Training in the regulations on the advertising on MDs/IVDMDs,
- Evaluation of whether your claims, communications, promotional documents and websites comply with the applicable requirements,
- Support to incorporate these requirements into your QMS, in particular through the drafting and implementation of an “advertising” procedure,
- Assistance when submitting applications to the ANSM where applicable.
Feel free to contact us using the contact form.
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