In October 2019, IMDRF released three harmonized documents, Clinical Evaluation, Clinical Evidence - Key Definitions and Concepts, and Clinical Investigation were finally released. China, as an IMDRF member and president for the cycle starting in 2018, proposed this global harmonization project for clinical evaluation. And as a project sponsor, China has been shown how the role of medical device supervision in China has changed from participation in an international effort to global leadership. Now, based on these final documents, NMPA published its draft updated guidance of clinical evaluation and is looking for comments.
The current regulations of the EU and China require a clinical evaluation report (CER) based on Guidelines on Medical Devices – MEDDEV 2.7/1 Revision 4, June 2016 and CFDA Technical Guidelines for the Clinical Evaluation of Medical Device (CFDA Announcement 2015 No.14). While both regulatory frameworks allow equivalent devices to be used as a basis for clinical data for a new device, due to the restrictions, it is much more difficult to do so under the requirements of MEDDEV 2.7/1 Revision 4 than under the Chinese guideline.
The new NMPA draft guidance referenced IMDRF documents and incorporates significant changes compared to the current version. Based on the current definition of clinical evaluation in China, which includes both CER and clinical trial, the manufacturer could select either to conduct a clinical trial or to write a clinical evaluation report to meet the current requirements. While according to the new guidance, clinical trial data will be one part of the data sources used in a clinical evaluation, which is very similar to MEDDEV 2.7/1 Revision 4 and MDR requirements.
In the meantime, the new guidance does not emphasize the comparison between product under evaluation and product of the same kind, which is mandatory now. But the level of detail in the report content can vary according to the scope of the clinical evaluation. For example, where a manufacturer relies on clinical data for a comparable device which has been the subject of an earlier clinical evaluation (for which the manufacturer holds the evaluation report), it may be possible to cross-reference the data summary and analysis sections to the earlier clinical evaluation report, which also becomes part of the clinical evidence for the device in question.
As the IMDRF documents are very close to the framework of MEDDEV 2.7/1 Revision 4, and NMPA guidance is mostly translated from IMDRF, it is expected in the future the CER under the requirements of MEDDEV 2.7/1 Revision 4 could be directly used for NMPA submission.
It has to be noted that the new guidance is still a draft and is asking for comments. There are still many uncertainties in this guidance, for example, the definition of clinical evaluation is that it is “a set of ongoing activities that use scientifically sound methods for the assessment and analysis of clinical data to verify the safety, clinical performance and/or effectiveness of the medical device when used as intended by the manufacturer”. However, as the registration and technical review in NMPA are different with the Notified Body in EU, it is not clear how manufacturers can demonstrate and continue to comply to the requirement of clinical evaluation is an ongoing activity. Also, the new guidance says the clinical evaluation report shall state if PMCF is needed, but until now, there is no specific guidance or regulation of the NMPA on how to perform the PMCF. We all need to keep looking for the next move about the final version guidance and its detailed official interpretations. The comments submission has been ended on Jan. 17, 2020, the final version guidance is expected to be released in this year.