The new European DM and DMDIV regulations (2017/745 and 746) require, in particular, the strengthening of staff responsible for regulatory affairs at NBs, manufacturers and agents.

Several hundred jobs are expected to be filled over the next few years, in a sector that is chronically short of specialized regulatory profiles.

This tension, combined with the strong growth prospects of the digital health sector (and therefore of digital DM solutions), requires a significant increase in the number of profiles in charge of regulatory affairs and conformity assessment in digital health.

The challenge is totrain 1,050 students in 7 new courses dedicated to medical devices at the M2 level of the "sciences of medicine and healthcare professions" master's degrees:

• These masters courses are widely open to pharmacy students involved in the industry stream, but also to scientists and engineers.
• These courses should include dedicated training in regulatory affairs.
• A second, complementary component will involve the introduction within these masters courses of two digitized awareness-raising modules, one focusing on medical devices in general, the other on the associated regulatory aspects.

As the primary lever for digital and ecological transitions, training young people and employees helps to strengthen the human capital essential to the functioning of our companies and, beyond that, of society as a whole. It's 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 skills needs of new sectors and professions of the future. 2.5 billion euros of France 2030 will be allocated to human capital to achieve this ambition.

The "Skills and professions of the future" call for expressions of interest is part of this framework and aims to meet companies' needs for training and new skills for professions of the future. Adapting and strengthening the training system for jobs in short supply will also strengthen our ability to achieve the objectives of France 2030.

This action must be carried out by a higher education establishment supported (or not) by a consortium that may integrate higher education establishments, hospital establishments and care structures and digital training players.