The publication on June 29th 2016 of the guide MEDDEV 2.7/1 revision 4 relating to the clinical evaluation of medical devices reinforces the requirements to match what is required by MDD regulation 2017/745.
Main changes that manufacturers need to anticipate are as follow :
- Frequency of update : depending on the risk classification of the device, a minimum frequency for updating the clinical evaluation report is expected (yearly for implant MD and class III MD).
- Justification of the competence of the assessors : the persons intervening in the clinical evaluation should justify at least 10 years of experience, or a degree in an appropriate field plus 5 years of experience. The clinical evaluation report must also mention that there is no conflict of interest, which may be hard to prove when the CER is done in-house.
- The demonstration of equivalence between the manufacturer’s MD and the competitor’s is even more complex. Is should be justified on clinical, technical and biological aspects, for which the equivalence must be total : it is getting more complicated to use competitor clinical data to evaluate your device.
- State of the art should be established : what are the therapeutic options and how the manufacturer’s MD is positioned regarding these options. It is requried to evaluate the risk/benefit balance for using the manufacturer’s MD instead of available alternatives.
- Two key-terms : performance and safety. In the CER, the manufacturer is required to define the level of clinical performance and patient safety that is to be expected. Whenever possible, the criteria should be measurable : clinical score, satisfaction rate, range of motion, survival rate … in conjunction with the design dossier.
With the simultaneous update to ISO 13485 : 2016 and the requirements of MDD regulation 2017/745 to anticipate, the workload for the update of the quality management system and the technical file is substantial.
Askorn can provide support in writting your clinical evaluation reports. Contact us to know more.