One of the significant changes in EU regulatory science for medical devices is the enhanced focus on clinical validity posed by the new Medical Device Regulation EU 2017/745 (MDR), published on 5 May 2017, and in transition until 26 May 2020.
Most manufacturers of medical devices have begun updating their clinical evaluations to comply with the revision of the guidance on clinical evaluation. The MDR describes additional requirements that should also be incorporated into compliant clinical evaluation plans and reports. Many manufacturers are struggling to achieve compliance with revision 4 and to prepare for the requirements of the MDR.
In this whitepaper, we address some of the most frequently asked questions on clinical evaluation.