There is a constellation of interacting and overlapping documents and reports. Each serves a distinct purpose. In addition, some plans are inside other plans and some reports are inside others. Think of this as the Russian Matrushka Doll strategy.
To see the required content of each plan, look at the specific reference I cite. To see the overlaps and differences, create a table that lists the elements of each plan and identifies each plan of which it is a member.
Clinical Evaluation, excluding clinical evaluation, identifies the current state of clinical knowledge about the type of device through literature collection and review. The Clinical Evaluation Plan, CEP, and the Clinical Evaluation Report, CER, are both pre-market activities. Many people, for historical reasons, incorrectly call the clinical evaluation system the CER. The CEP elements are in Annex XIV14(1)(a). The CEP is not part of another plan.
The Clinical Development Plan, CDP, is the strategy to develop the device from exploratory investigations to confirmatory investigations, The CDP is a pre-market activity. It does not have an associated Clinical Development Report. Annex XIV14(1)(a)(eight indent) describes the CDP. The CDP is part of the CEP.
Risk Management is the method to reduce patient and user risks to an acceptable level. The Risk Management Plan, RMP, is a pre-market activity. Annex I(3)(a) requires an RMP; the elements are in EN ISO 14971:2019, 4.4. Risk Management does not require a report in the sense of other MDR reports. The RMP is part of the Risk Management File, but not part of any other plan.
Post-market surveillance is a method to collect and evaluate general information about the device in the post-market phase. The Post-Market Surveillance Plan, PMSP, is a pre-market activity. The PMS Report or the PSUR (depending on device class) is a post-market activity. The PMSP elements are in Annex III(1)(b). The PMSP is not part of another plan.
Post-market Clinical Follow-up, PMCF, is a method to collect and evaluate specific and focused information about a device in the post-market phase. Determine the need for PMCF by reviewing the information from the Clinical Evaluation System and from the Risk Management System. The PMCF Plan is a pre-market activity and the PMCF Evaluation Report is a post-market activity. The PMCF Plan elements are in Annex XIV(6.2). The PMCF Plan, if required, is part of the PMS Plan and the CEP.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
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Original Message:
Sent: 04-Dec-2021 19:16
From: Anonymous Member
Subject: Clinical Evaluation Plan and PMCF Plan what are the diff ?
This message was posted by a user wishing to remain anonymous
I know that Clinical Evaluation is created prior to placing the device on the market
however, in my CEP I can also define the proactive ways to proactively and continuously collect and analyze clinical data for the purpose of updating the CER (once the device is marketed) and define the time intervals to update the CER so why do I need a PMCF Plan?