The clinical evaluation report need to be provided for all medical devices without exception and shall be updated at regular intervals depending on their classification, sometimes annually, to keep the newest status. Evidence of safety, performance and clinical benefit is based on clinical data that could be obtained from various sources. The Guideline MEDDEV 2.7/1 Revision 4 offers helpful guidance on the content and implementation of the clinical evaluation report. Stricter, legal requirements are implemented with the validity of the Medical Devices Regulation 2017/745.
A special challenge is the approval of medical devices in the Chinese market. Again, a clinical evaluation is necessary for your registration. Furthermore, specific requirements are set by the Chinese regulatory authority, the CFDA (China Food and Drug Administration). The CFDA clinical evaluation report should be complied with the corresponding guidelines. Our specialists in this field are native speakers and have extensive experience in CFDA approval.
In addition, our processes ensure that the current regulations are met, when creating and updating clinical evaluation reports. Are your clinical evaluations still up to date? Take advantage of the expertise of PROSYSTEM GmbH and let us help you to create and update your clinical evaluation report. You also can visit our seminar and our experts will train you on the subject of clinical evaluation and advice you comprehensively. In this way, you gain valuable competitive advantages and accelerate your market access.
Our Clinical Evaluation services include:
- Creation and update of clinical evaluations in German or English according to MEDDEV 2.7/1 Revision 4, Medical Devices Regulation 2017/745 or CFDA requirements
- Evaluation of the clinical data. Identify if a clinical trial is necessary to obtain approval in the EU or in China.
- Gap analysis according to medical device regulation 2017/745 or CFDA requirements
- Implementation of the relevant processes and forms
- Which marketing claims can be used?
- Are all clinically relevant risks considered?
- Database research of clinical experience data
- Risk-benefit assessment
- Conducting literature reviews
- Preparation of procedural instructions and forms
- Training your colleagues with training certificate