In order to successfully implement the Medical Device Regulation (MDR), there is a great need for training and further education for regulatory authorities, notified bodies and clinicians involved in the authorisation process. As part of the EU CORE-MD project, the project was tasked with identifying training needs and making proposals for training content. In addition to an overview on academic training institutions and programmes, a survey was conducted. 409 experts in medical products answered the survey on their training needs. Based on the perceived training needs, targeted trainings are recommended.

Recommendation 1: A needs-based (modular) curriculum: A modular curriculum is proposed that can be adapted to the training needs of the three stakeholder groups, encompassing a Core Set of training sessions and activities, complemented by modules for further specialisation. The modular composition would offer educational elements tailored for the respective tasks and specific objectives of each group that can be provided at different stages of a career: at the academic curriculum stage (initial or advanced degree) or during/in parallel to work life (single days, block training modules, webinars, sessions at congresses, practical training on the job, etc.).

Recommendation 2: Training-on-the job ("job-shadowing"): Hands-on experience, training-on-the-job and re-skilling of professionals often takes place during work life. Possible training opportunities could be: the development of an internship scheme, short-term sabbatical attachments with manufacturers, Notified Bodies, competent authorities, similar to activities offered at FDA and TGA. The training-on-the-job needs to ensure that it can be attended parallel to the main employment (e.g. for clinicians).

Recommendation 3: EU Network Training Centres: A Network Training Centre (NTC) at the European Medicines Agency (EMA) supports the educational and training needs of EU pharmaceutical regulators. A new initiative aims to create a similar European-wide network for the national Competent Authorities for medical devices. Its objectives are to improve the quality, consistency and efficiency of the work of the medical device regulatory network; to promote harmonised operation of the regulatory framework and guidelines throughout the European regulatory network; to foster science-based assessment, and to provide continuous professional development for staff of national regulatory agencies and possibly other stakeholders involved in the development of regulations for medical devices.

Recommendation 4: Targeted training for clinicians adjusted to the regulatory science skills they need in their daily jobs: Many clinicians only have a basic understanding of regulatory affairs, the way in which the medical devices and medicines that they use are approved, procedures for post-market surveillance, and how clinicians can contribute. Because of their heavy workload, flexible approaches are needed.