The new European MDR and IVDR regulations (2017/745 and 746) require, among other things, that staff in charge of regulatory affairs at NBs, manufacturers and agents be increased.

Several hundred jobs are expected to be filled in the years to come, in a sector with a chronic shortage of specialized regulatory backgrounds.

This tension, combined with the strong growth prospects of the eHealth sector (and therefore of digital medical device solutions), requires a significant increase in the number of people in charge of regulatory affairs and compliance assessment in eHealth.

The challenge is to train 1,050 students in 7 new courses dedicated to medical devices at the M2 level of "Pharmaceutical Sciences and Health Professions" master's degrees:

• These masters are widely open to pharmacy students involved in industry, and also to scientists and engineers.
• These courses should include training in regulatory affairs.
• A second complementary aspect will be the implementation of two digitized awareness modules within these masters programs, one on medical devices in general, the other on related regulatory matter.

As a way to serve the digital and ecological transitions, the training of young people and employees allows us to strengthen the human capital that is essential to the functioning of our companies and, beyond that, to society as a whole. It is also the best way to offer sustainable jobs at all skill levels throughout the country.

This is also one of the major conditions for the success of the France 2030 plan: supporting the emergence of talent and accelerating the adaptation of training to the skill needs of emerging sectors and professions of the future. €2.5 billion from the France 2030 plan will be spent on human capital to achieve this ambition.

The "Skills and Professions of the Future" call for expressions of interest (the “CMA AMI”) is part of this framework and aims to meet the needs of companies in terms of training and new skills for the professions of the future. Adapting and reinforcing the training system for jobs facing labor shortages could also strengthen our ability to achieve the France 2030 objectives.

This action must be carried out by a higher education institution supported (or not) by a consortium that may include higher education institutions, hospitals and care structures, and digital training actors