Hamburg, 01.10.2021, Yannan Xu

NMPA has released 5 CER-related clinical evaluation guidelines for medical devices. The manufacturers have to further prepare their CERs according to the new guidelines and we are now working on preparing a new template.

  1. Medical device equivalence demonstration guideline
  2. Medical device clinical evaluation guideline
  3. Medical device clinical evaluation report guideline
  4. Technical guideline about decision whether to carry out clinical trials of medical devices
  5. Technical guideline for the comparison of products included in the catalog of medical devices exempt from clinical evaluation

Some new/different requirements:

  1. In addition to „equivalent device“, „comparable device/similar device“ is now formally defined. The data of a comparable/similar device could also be used to demonstrate the safety and performance of the device under application in a separate chapter.
  2. A new structure of CER is suggested -> new template needed
  3. Higher demand about the relevance and contribution of the clinical data -> weighting system for literature is also suggested.
  4. More PMS analysis requirements
  5. Information such as clinical claims, benefits, medical alternatives/state of the art should also be included and considered. The scope of application of the product, the clinical use information described in the IFU and label should be supported by appropriate clinical evidence, and all hazards that may affect the use of the product and other clinically relevant information are included.