The combination of new materials (e.g. in tissue engineering), new methods of testing (e.g. computer-aided modelling, simulation), and new technologies (e.g. neuroprosthetics, artificial intelligence) means that regulators, staff in Notified Bodies, and clinical experts such as those acting as advisers to Notified Bodies or as members of Expert Panels, must keep pace with technological developments and continually develop their regulatory capabilities.
A recent position paper from the Medical Device Coordination Group (MDCG 2022-14) recognised and emphasised the requirement to build capacity for an effective transition to the MDR and the IVDR [(EU) 2017/746 on In Vitro Diagnostic Medical Devices]. This comprises not only assuring good knowledge of the legislation (MDR, IVDR), regulatory policies, and instruments including MDCG guidance documents – covered under the umbrella term of ‘regulatory affairs’ – but also enabling more in-depth and specific knowledge of advanced methodologies for the evaluation of medical devices in pre-clinical and clinical investigations and post-market surveillance evaluations.
In this framework, a landscape overview of existing training offers and a series of exploratory interviews were conducted, to prepare a survey among regulators, Notified Bodies and clinicians who contribute to the implementation of the medical device regulations.
The online survey was launched in summer 2022, and it collected the perceived needs for training in regulatory sciences and in core methodological competencies as well as the views of the respondents on training formats and modalities.
409 experts responded to the survey:
- 68% (278 people) were clinicians, of whom 23% (n=64) were already part of an EU Expert Panel.
- 14% identified as regulators (n=58)
- 9% were employees of Notified Bodies (n=37)
- 9% chose ‘other’ employment category (n=36)
The results of the survey are available here
