Clinical Evaluation

A clinical evaluation must be prepared for medical devices of each risk class and updated at regular intervals, sometimes every year. The evidence of safety, performance and clinical benefit is based on clinical data that can come from a variety of sources.

Clinical Evaluation Plan
Within the framework of the clinical evaluation, a clinical evaluation plan (CEP) must be drawn up to demonstrate a “well-defined and methodically sound procedure” (Article 61 of Regulation (EU) 2017/745). The plan must identify the basic safety and performance requirements; define the purpose, the target groups and the clinical benefit; and describe the clinical evaluation methodology.

Approval for the European Market
Guideline MEDDEV 2.7/1 Revision 4 provides helpful guidance on the content and performance of the clinical evaluation report. Stricter requirements will be implemented with Regulation (EU) 2017/745 (MDR, Medical Devices Regulation). The conditions for the use of equivalence data of a comparable product as well as the type and extent of clinical evidence are more strictly regulated.

Approval for the Chinese Market via NMPA (formerly CFDA)
For approval in the Chinese market, a clinical evaluation is needed. Specific requirements are set by the Chinese regulatory authority, the National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA). Our specialists are native speakers and have extensive experience in NMPA/CFDA certification.

Do you need assistance with your clinical evaluation?
Are your clinical evaluations still up to date or do you require an analysis and evaluation of the clinical data on your product for market approval? Is your equivalent device still usable? Take advantage our expertise in the analysis, conduct and updating of your clinical evaluation, in compliance with current regulations. Attend our seminar for expert training and advice. Secure valuable competitive advantages and accelerated market access.

Clinical Evaluation services:

  • Creating a clinical evaluation plan
  • Conducting and updating clinical evaluations in German or English in accordance with MEDDEV 2.7/1 revision 4, Regulation (EU) 2017/745 or NMPA requirements
  • Evaluating clinical data (Is a clinical investigation necessary to obtain approval in the EU or in China?)
  • Identifying gaps in Regulation (EU) 2017/745 or NMPA requirements
  • Creating and implementing relevant processes, forms and procedures with integration of essential interfaces
  • Conducting literature reviews
  • Evaluating marketing claims
  • Assessing clinically relevant risks
  • Database research of clinical experience data (e.g. BfArM, Swissmedic, MHRA, FDA MAUDE, FDA Recall, NMPA/CFDA Database for Medical Devices Adverse Events, NMPA/CFDA Recall Database and ADR Monitoring (China) Database)
  • Risk-benefit assessment
  • Training or workshop with training certificate

For more details on “Clinical Evaluation” or for a non-binding offer, please contact us.