Post Market Clinical Follow Up (PMCF)
Post Market Clinical Follow Up (PMCF) is a part of the Post Market Surveillance (PMS) activity and is understood to be a continuous process that updates the Clinical Evaluation. It is carried out following the CE marking of a device.
The manufacturer should collect clinical data from the use in or on the humans after it has been commercialized or put to service within its intended purpose as referred to in the relevant conformity assessment procedure.
It should be done with the aim of confirming the safety and performance of the device throughout its expected lifetime. It should ensure the continued acceptability of identified risks and of detecting emerging risks on the basis of fact-based evidence.
Purpose of Post Market Clinical Follow Up
The purpose of Post Market Clinical Follow Up is as follows:
a) to gather information regarding:
-clinical observations only seen in a larger user/patient population;
-clinical observations only seen after long-term use of the device.
b) verification of clinical risk-benefit analysis conclusions.
PMCF requirements as per EU MDR
As per the MDR, it should be carried out to proactively collect and evaluate clinical data per the method laid out in the PMCF plan which aims at:
- confirming the safety and performance throughout the expected lifetime of the device,
- identifying previously unknown side-effects and monitoring already identified side-effects and contraindications,
- identifying and analyzing emergent risks based on factual evidence,
- ensuring the continued acceptability of the benefit-risk ratio, and
- identifying possible methodical misuse or off-label use of the device, with a view to proving that the intended purpose is correct.
If through PMCF, the need for preventive and/or corrective measures has been identified, the manufacturer must implement them.
PMCF requirements as per MEDDEV 2.12/2 Rev. 2
The clinical evaluation documentation must be actively updated with data obtained from PMS. Where PMCF as part of PMS is not deemed necessary, this must be duly justified and documented (Exemption).
Post Market Clinical Follow Up Plan
As per the MDR, a PMCF plan must include, at least:
- the general methods and procedures to be applied, such as the gathering of clinical experience gained, feedback from users, screening of other sources of clinical data and of scientific literature;
- the specific methods and procedures of PMCF to be applied, that is the evaluation of suitable registers or post market clinical studies;
- a rationale for the appropriateness of the methods and procedures referred in the above-mentioned points;
- a reference to the relevant parts of the clinical evaluation report and to the risk management;
- specific objectives to be addressed by the PMCF;
- an assessment of the clinical data relating to equivalent or similar devices;
- reference to any relevant Common Specifications, harmonized standards when used by the manufacturer, and relevant guidance and
- a comprehensive and adequately justified time schedule for PMCF activities (e.g. detailed examination of data and reporting) to be undertaken by the manufacturer.
Post Market Clinical Follow Up Report
The manufacturer must analyze the findings of the Post Market Clinical Follow up and record the results in a the Evaluation Report which should be part of the clinical evaluation report and the technical documentation.
For class III and implantable devices, the evaluation report must be updated at least annually.
What are the conditions when above such studies might not be required?
- When the medium or long-term safety and clinical performance are already known from previous use of the device;
- Where other appropriate post-market surveillance activities would provide sufficient data to address the risks.
What are some of the cases that justify PMCF studies?
- innovation, e.g., where the design of the device, the raw materials, the principles of operation, the technology or the medical indications are novel;
- high-risk target populations e.g. paediatrics, elderly;
- high product-related risk e.g. based on design, materials, components, invasiveness, clinical procedures;
- identification of previously unstudied subpopulations which may show different benefit/risk-ratio e.g. hip implants in different ethnic populations and so on…
State a few examples of methodologies to carry-out PMCF studies?
- the extended follow-up of patients enrolled in premarket investigations;
- a new clinical investigation;
- a review of data derived from a device registry; or
- a review of relevant retrospective data from patients previously exposed to the device.