The new EU MDR (medical device new CE Marking regulation) aims to set “high standards of quality and safety for medical devices by ensuring amongst other things that clinical investigations are reliable and robust and that the safety of the subjects participating in a clinical investigation is protected”. It also addresses the “rights of the subject to physical and mental integrity, to privacy and to the protection of the data”. To achieve that the MDR contains new articles and annexes that impose new requirements from clinical investigation used to support CE Marking of medical devices.
Companies that will fail comply with the new requirements from clinical investigations can expect nonconformities and risk their CE Marking certificates.
- Overview of the new MDR expectations from clinical investigations
- Intersection with GDPR
- Intersection with the “clinical evaluation process”
- Clinical Affairs Professionals
- Clinical Trials Professionals
- Regulatory Affairs Departments
- Project Managers