Organizations in charge of conformity assessment for digital and connected medical devices, and in particular notified bodies, are having difficulty recruiting qualified profiles to meet the demand for conformity audits, mainly for CE marking of medical devices.

For the CE marking of medical devices, these organizations are actively looking for reviewers, auditors and clinicians.

European regulations require the use of people with experience (several years required) and no ties of interest to the audited companies, which limits the pool of potential candidates. For years, this chronic lack of available candidates has been a major obstacle to the marketing of digital medical devices, especially for new entrants to the sector who do not have an established commercial relationship with Notified Bodies (NBs). The need for experienced evaluators is estimated to be approximately 300 jobs over the next 5 years.

This action is part of a global approach, based on other SASN actions (see Diagnostics and regulatory processes and CE marking) and the “DM 2030” plan. The increase in training for regulatory affairs, compliance assessment and eHealth officers is already underway (see Regulatory affairs, compliance assessment and eHealth officers). This measure will eventually help to fill the need for evaluators, provided that the higher education institutions concerned promote the opportunities associated with conformity assessment.

As to the more specific need for clinical evaluators, such candidates can perform this duty while continuing their regular work, an opportunity that is still not widely known. Outreach to the practicing medical professions should help make it easier to recruit the talent that is needed.

Two joint actions are therefore necessary and are under consideration by the Ministry:

• Promoting opportunities related to compliance assessment among faculty in eHealth training who are being supported under the strategy.
• Making health professionals aware that they have the opportunity to carry out their normal work alongside occasional evaluation missions as clinical experts in notified bodies.