Organizations in charge of conformity assessment for digital and connected Medical Devices (MDs), and in particular notified bodies, are finding it difficult to recruit qualified profiles enabling them to meet the demand for conformity auditing mainly on CE Medical Device marking.

With regard to Medical Device CE marking, these bodies are actively seeking examiner, auditor and clinician profiles.

European regulations require the use of experienced profiles (several years' experience required) and with no ties of interest to the companies audited, which stretches the pool of potential profiles. For years, this chronic shortage of available profiles has been a major obstacle to the market launch of digital DMs, particularly for new entrants to the sector with no established commercial relationship with Notified Bodies (NBs). The need for experienced evaluators is estimated at around 300 jobs over the next 5 years.

This action is part of an overall approach, which builds on other SASN actions (See Diagnostics and regulatory processes and Regulatory affairs, conformity assessment and digital health officers). In the long term, this measure will help to fill the need for assessors, provided that the higher education establishments concerned promote opportunities linked to conformity assessment.

With regard to the more specific needs for clinical assessors, these profiles can perform this function concurrently, an opportunity that is still too little known. Raising awareness among the practicing medical professions should make it easier to recruit the talent we're looking for.

As regards the more specific needs for clinical appraisers, these profiles can be combined with other activities, an opportunity that is still too little known.

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

• Value the opportunities linked to conformity assessment among teachers of digital health training courses supported as part of the strategy;
• Sensitize the healthcare professions to the possibility of combining their activity with occasional assessment missions as clinical experts in notified bodies.