Terminology is very important here. Many people, incorrectly, use CER to describe the clinical evaluation process. This is a carry over of ppor practice from the MDD. The MDR has changed the requirements making the distinction much stronger. In the MDR there are three documents as part of the initial Clinical Evaluation and each serve a different purpose. The Clinical Evaluation Plan, CEP, describes how you will learn clinical data, the Clinical Evaluation Report, CER, describes what you learned, and the Clinical Evaluation Assessment Report, CEAR, is the NBs assessment of your Clinical Evaluation process.
Clinical Evaluation is a pre-market activity meaning you have a complete CEP, CER, and CEAR before putting the CE Mark on the product. Post-market activities update the the Clinical Evaluation.
Clinical Evaluation is intended to learn about device risks, device benefits, and support for applicable GS&PR items.
To develop the plan, use the indents in MDR Annex XIV(1)(a) as section headings and then complete the details. However, if you have a legacy device follow the modifications in MDCG 2020-6 Appendix II.
Notice that MDR Annex XIV does not have a prescribed format for the report. Also notice that MDCG 2020-6 Appendix I doesn't list MEDDEV 2.7/1 Rev. 4 Appendix A9 as applicable to legacy devices. For one of my clients the NB Reviewer refused to read the CER because he said it was not in the state-of-the-art format required by Appendix A9. Discuss the format of the CEP and the CER with the NB to learn what expectations they have.
In the post-market phase you need a Post-market Surveillance Plan. It captures broad information about the device in the post-market (after the CE Mark) phase. The report contents are in an article depending on the device class.
PMCF focuses on specific information. The first step is to decide if you need PMCF. For my clients I combined the items in MEDDEV 2.12/2 Rev. 2 and the draft IMDRF document into a Yes/No evaluation. Any Yes means conduct a PMCF. All No provides the rationale for no0t conducting PMCF. You will need to look at the results of the Clinical Evaluation (pre-market) and Risk Management (pre-market) to determine if you to obtain additional information
Follow MDR Annex XIV(6.2) for the sections of the plan. Notice that it requires specific objectives and a time schedule.
Also note that depending on the device there could be no PMCF, one PMCF, or multiple PMCF.
In summary, there are three plans you need to consider.
Clinical Evaluation Plan is broad and is in the pre-market phase
Post-market Surveillance Plan is broad and in the post-market phase
Post-market Clinical Evaluation Plan is narrow and if required is in the post-market phase
Each plan has a different purpose and different requirements, so you need different plans.
------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------
Original Message:
Sent: 10-Jun-2022 14:22
From: Anonymous Member
Subject: Clinical Evaluation Plan and PMCF Plan What are the differences?
This message was posted by a user wishing to remain anonymous
What are the differences between CER Plan and PMCF Plan?
What I am asking is why do I need to have a dedicated PMCF Plan? can't we just have a dedicated section in the clinical evaluation plan that describes the PMCF?
Instead, we must have a dedicated PMCF Plan that is part of the PMS Plan, and the conclusions of the PMCF should be documented in the CER report.
Am I missing something?