A glance into the Medical Device Regulation (EU) 2017/745 (MDR) , the relevant MDCG documents (including MDCG 2020-13 Clinical Evaluation Assessment Report Template/CEAR), and MEDDEV 2.7/1 , repeatedly reveals the instruction to use data from PMS and Post-Market Clinical Follow-up (PMCF) in the Clinical Evaluation, and conversely, to use clinical results in PMS reporting. To make it easier for you to write the PMS section in the Clinical Evaluation, we have extracted for you the required contents, their mentioned location, and their movement between the reports, from the regulations of the MDR and MDCG 2020-6 (legacy devices), MDCG2020-7 (PMCF-Plan), MDCG2020-8 (PMCF-Report), MDCG 2020-13 (CEAR), as well as MEDDEV 2.7/1 (Clinical Evaluation ) and 2.12/1 (Vigilance) .
There are two crucial passages in the MDR regarding the relationships between PSUR, PMS, PMCF, and CER:
This does not result in a contradiction if you pay close attention to the wording: reports are not mentioned as sources. Therefore, write - or rather complete - your reports in this sequence:
This fulfills MDCG 2020-13 in section A: "When the CER has been updated verify that this update corresponds to the most recently updated PMS/PMCF reports" without any problems referencing released documents.
Please ensure that all necessary updates are carried out within a tight time frame so that the intervals between obtaining the data (e.g. literature search) and reporting are not too long (a maximum of 6 months).
Sounds surprising at first, doesn't it? In practice, the usual procedure is the other way around, i.e., when an update is pending, the Clinical Evaluation Plan is first updated, followed by the Clinical Evaluation Report. This is because typical templates provide for updating the Clinical Evaluation Plan according to the new findings in PMS.
But let's consider whether this actually (always) has to be the case. Let's remember the fundamental sequence of every activity: Plan - Do - Report.
So, if we are in the updating phase, we have reached the end of the Do phase! Therefore, the results should first be summarized in the report. Deviations from the Clinical Evaluation Plan, e.g., in in key terms for literature search, can be disclosed in the Clinical Evaluation Report and explained by reacting to new information. And if data emerges differently than planned, it will not be ignored in the report.
Once all analyses and conclusions from the PSUR and CER are available, the Clinical Evaluation Plan can respond to and be updated if necessary - just as the PMCF plan is now updated based on the Clinical Evaluation Report.
Then the whole process starts over with the next Do period of activities according to the planning.
We know that, in practice, individual solutions are always needed to implement the requirements of the MDR as efficiently as possible and in line with adjacent processes. Therefore, we not only consider alternatives in the sequence of activities but also a flexible design of documentation.
For example, if separate documents are maintained for CEP, literature search plan, CDP (Clinical Development Plan), and PMCF plan, the CEP can be designed so that it does not describe specific activities. It then represents a top-level plan and describes what needs to be evaluated and considered. This way, the CEP can be updated any time when needed without a chain reaction.