The (EU) 2017/745 (MDR) describes the regular update of clinical evaluation through the PMCF report. Therefore, a mechanism is added that is upstream/intermediate to the previous implementation compared to the MDD. The post-market clinical follow-up (PMCF) does not replace the clinical evaluation as it is an additional aspect. This results in some activities that are relevant at a different time than before. What documents are needed at the beginning for the MDR certificate and where is the best starting point for these recurring activities? This blog will tell you; focusing on legacy devices (these medical devices with an MDD certificate are already on the market and are no longer in development).

What does the PMCF-CER cycle look like?

To describe the PMCF/clinical evaluation system, it helps to place yourself mentally at that point in an established product’s life cycle where a new observation period begins.

A) The clinical evaluation plan (CEP) stands above all activities, and it fundamentally specifies which aspects are to be clinically evaluated when using the product. It also specifies the general strategy. In the CEP

• the clinically relevant aspects to be analyzed are specified,
• the associated parameters are planned,
• the route is defined, e.g. equivalence or study,
• the handling of the data to be collected is described, and
• the clinical development plan (CDP), which describes the clinical activities during development, is defined.

B) The clinical evaluation report (CER) states what data you need for continued monitoring and confirmation – after analyzing the evidence base. These are based on the conclusions of your CER.

C) The PMCF plan describes which clinical activities are planned in the market phase to obtain these data from the use of your product. The PMCF plan can be understood as an umbrella document for the individual plans of the different PMCF activities: For example, a required continued literature search is described in detail in the lower-level literature search plan, including the exact search terms, selection and appraisal criteria. Or in the example of a required clinical trial, the PMCF plan specifies the basic design and schedule. The detailed plan for this single activity corresponds to the clinical investigation protocol (CIP).

D) After planning, the activities are implemented. These are to be recorded in a literature report, clinical investigation report (CIR), or other records – and in interim reports with longer duration. The resulting new data are summarized and evaluated in the PMCF report. Information relevant to various parts of the technical documentation is discussed, and the effectiveness of current measures is assessed. A PMCF report only covers the respective observation period of the current cycle.

The CER’s next update can integrate the newly obtained data into the overall evidence, analyze the updated overall data situation (against the background of the also updated state of the art). If necessary, the benefit/risk ratio discussion is to be adjusted. Only the CER can determine (continued) compliance with the GSPRs (general safety and performance requirements), not the PMCF report. The CER concludes with the uncertainties and unanswered long-term questions that continue to be observed through PMCF. If necessary, this will require an adjustment to the PMCF plan.

One sentence to avoid redundancy: It is a good idea to reference shareable attachments, or design Excel-based data sets or other internal forms of cumulative data collection. This will help you avoid unnecessarily recording data multiple times (in individual log, PMCF report, and CER).

How to get an MDR certificate?

We start in the MDD world:

1. raise CEP to MDR level - on this occasion it is worth cleaning up and improving,
2. carry out the activities (planned so far),
3. raise CER to MDR level, insert and analyze the new data (again, it is worth cleaning up and improving)
4. derive the PMCF plan,
5. submission to the notified body and
6. finally create MDR certificate.

Take these steps independently of the previously planned rhythm of CER updates. You are setting the clock back to zero ahead of schedule.

Additional info: It is possible to skip step 2 and write the CEP, CER and PMCF plan documents, which are only formally adapted to the MDR. However, this will then be an interim CER that will soon have to be updated at the old rate. It is very likely that the initial PMCF plan will then have to be amended. We do not recommend this procedure, as it does not result in any "real" time savings.

This is what the regular updates under MDR look like

Step 1: The CEP only needs to be amended if you plan to make changes to the product or its intended use, or external factors necessitate additional clinical consideration. How do you document that you have reviewed just that? Version the CEP and reference the last (current) PMS report and any changes as appropriate. By the way, a change is to be considered like a new development, so do not forget to revive the CDP.

Step 2: The reports on the individual PMCF activities and the PMCF report are written regularly.

Step 3: The CER is updated on a regular basis.

Step 4: The PMCF plan is modified when required by the updated CER or when the effectiveness of the activities has been judged to be insufficient. Without changes, no versioning is required here as with the CEP. The explicit conclusions in the PMCF report and CER already prove that you have considered the need for an update.

Conclusion

It is important that you revise your medical device PMCF/clinical evaluation system in accordance with MDR. If you follow the recommendations in this blog, your system should run smoothly, and you will not have any problems with a smooth start.

Do you have questions about the PMCF-CER cycle or other clinical affairs topics? Together we can find a solution for (almost) everything. We would also be happy to take full care of your clinical evaluation - so you never miss an update and get everything from a single source". We look forward to hearing from you. Good luck!

Best Regards