Every manufacturer of a medical device has to demonstrate compliance with the General Safety and Performance requirements according to (EU) 2017/745 (MDR, Medical Device Regulation) both during the approval process as well as in the post-market phase. A clinical evaluation has to be created and maintained for each device that is CE marked as a medical device.
The clinical evaluation includes the analysis and evaluation of data of a medical device with the aim of demonstrating performance and safety in clinical use. Furthermore, the clinical evaluation examines:
- Whether a clinical benefit exists and whether the manufacturer makes justifiable claims about the device in marketing materials.
- Whether all existing risks have been adequately addressed by the manufacturer and whether existing residual risks are acceptable.
- Which activities have to be planned and carried out within the framework of PMCF (Post-Market Clinical Follow-up) in order to address, for example, unexpected side effects or questions regarding safety and performance that have not been completely clarified.
The preparation of a clinical evaluation report according to (EU) 2017/745 and MEDDEV 2.7/1 Revision 4 places increased demands on resources and competence. The MEDDEV 2./71 Revision 4 and the MDR require
- A sound plan for clinical evaluation
- Increased quality of clinical data that can be used for conformity assessment
- A very high similarity and sufficient access to the technical documentation to rely on data from equivalent devices
- Comprehensive and cross-linked argumentation
- Competent authors and reviewers
Learn more about each requirement here.
Are you unsure whether your data situation will be sufficient under the new regulation? You do not have time to set up and carry out a systematic literature search according to MEDDEV 2.7/1 Revision 4? We know the requirements and will be happy to help you plan, prepare or revise your clinical evaluation and the corresponding literature search, taking into account your individual priorities.
Curiously we are waiting for your enquiry.