Strengthening the compliance team for medical device advertising compliance

Faced with a significant increase in activity and one person on maternity leave, our client – a French pharmaceutical laboratory – was looking to maintain its level of productivity and efficiency in the field of advertising compliance for medical devices. To satisfy this need, we were asked to strengthen their Compliance team, ensuring the rigorous validation of various promotional and non-promotional materials.

Context

Our client, a leading pharmaceutical company, saw its advertising compliance needs grow due to an increase in its activities and a person on maternity leave within its Compliance team. The assignment involved managing advertising compliance for a wide range of products, including injectors, syringes, artificial intelligence algorithms, image processing, and cancer detection software, as well as various consumables.

The main challenges included the validation of promotional and non-promotional materials in accordance with the Compliance department’s internal procedure; these materials were disseminated through several channels, such as websites, social networks (LinkedIn), the YouTube platform, and at congresses. The objective was to ensure that all communications complied with the requirements of European regulations (Article 7 of MDR 2017/745) as well as the local requirements of the competent authorities in the countries concerned, whilst protecting patients and disseminating accurate and truthful information about the safety and performance of medical devices to patients and healthcare professionals.

Description of the assignment

The mission focused on several key areas:

• Validation of promotional materials: We carried out a complete validation of promotional and non-promotional materials, checking their compliance with European and local regulatory requirements. The materials examined included websites, brochures, banners, emails, social media posts, press releases, symposium presentations, and YouTube videos.
• Standards and regulatory watch: A standards and regulatory watch procedure was put in place to ensure continuous monitoring of changes in standards and regulations. This ensures ongoing compliance with current requirements.
• Gap analysis: A gap analysis form was developed in order to assess differences between versions of standards and regulations published in the sector, thus facilitating the updating of practices and procedures.
• Management of non-conformities: We created deviations for validated non-conforming materials and managed non-conformities arising from the department’s internal audits, ensuring continuous process improvement.

Results

This assignment enabled us to achieve several key objectives:

• Maintaining advertising compliance: We ensured that all promotional materials complied with applicable regulations, minimising the risk of sanctions and misleading advertising.
• Improved internal processes: The introduction of the regulatory watch procedure and gap analyses strengthened the department’s ability to keep up to date with constantly changing requirements.
• Valuable additional support: In addition to our main tasks, we provided valuable support in other critical areas of the department, relating to operational quality, which were particularly appreciated by the client.

In conclusion, this assignment highlighted our expertise in advertising compliance management and helped maintain a high level of quality and compliance for all products marketed by our client.