Making data protection work for scientific research: MedTech Europe response to European Data Protection Board Guidelines

MedTech Europe has published its response to the European Data Protection Board’s (EDPB) draft Guidelines on processing of personal data for scientific research purposes, which aim to clarify how Europe’s data protection rules apply to research activities. For the medical technology sector, this is particularly important, as innovation in medical devices, diagnostics, and digital health relies on the responsible use of health data to develop safer, more effective technologies and improve patient outcomes.

While welcoming the initiative, MedTech Europe highlights that further clarification is needed to ensure the rules are workable in practice. This includes recognising different types of research, supporting appropriate legal bases beyond consent, and aligning data protection guidance with existing sector-specific regulations such as the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).

The response also identifies practical challenges related to anonymisation, data reuse, and the growing use of artificial intelligence in research. Ensuring that data protection rules are clear and proportionate is essential to enable responsible research, support innovation, and ultimately deliver better outcomes for patients across Europe.

Read our response via the link below.