Post Market clinical follow up

Dr Klinisch research provide a Comprehensive and End to End Clinical Trail Management Services for Medical Devices Industry, which includes Clinical Research strategy, Clinical Trial Management and Post market clinical follow-up services.

The PMCF (Post-Market Clinical Follow-up) is performed after a medical device has been placed on the market. The goal of the PMCF is to update the clinical evaluation report with new data on patient safety and device performance following the CE marking of the device.

The Annex XIV Part B of the MDR is entirely dedicated to the PMCF and defines it as: “PMCF shall be understood to be a continuous process that updates the clinical evaluation referred to in Article 61 and Part A of Annex XIV of MDR and shall be addressed in the manufacturer’s post-market surveillance plan”.

When conducting PMCF, the manufacturer shall proactively collect and evaluate clinical data from the use in or on humans of a device which bears the CE marking and is placed on the market or put into service within its intended purpose as referred to in the relevant conformity assessment procedure, with the aim of confirming the safety and performance throughout the expected lifetime of the device, of ensuring the continued acceptability of identified risks and of detecting emerging risks on the basis of factual evidence.

PMCF shall be performed pursuant to a documented method laid down in a PMCF plan

The PMCF plan shall specify the methods and procedures for proactively collecting and evaluating clinical data with the aim of:

Confirming the safety and clinical performance of the device throughout its expected lifetime

Identifying previously unknown side-effects and monitoring the identified side effects and contraindications

Identifying and analyzing emerging risks on the basis of factual evidence

Confirming the safety and clinical performance of the device throughout its expected lifetime

Ensuring the continued acceptability of the benfited-risk ratio

Identifying possible systematic misuse or off-label use of the device with the intent to verify that the intended purpose is correct.

The PMCF plan shall include at least:

The general methods and procedures of the PMCF to be applied, such as gathering of clinical experience gained, feedback from users, screening of scientific literature and of other sources of clinical data

The specific methods and procedures of PMCF to be applied, such as evaluation of suitable registers or PMCF studies

A rationale for the appropriateness of the methods and procedures

A reference to the relevant parts of the clinical evaluation report referred to in Section 4 and to the risk management referred to in Section 3 of Annex I of MDR

The specific objectives to be addressed by the PMCF

An evaluation of the clinical data relating to equivalent or similar devices

Reference to any relevant CS, harmonised standards when used by the manufacturer, and relevant guidance on PMCF

A detailed and adequately justified time schedule

The manufacturer shall analyse the findings of the PMCF and document the results in a PMCF evaluation report that shall be part of the clinical evaluation report and the technical documentation.

The conclusions of the PMCF evaluation report shall be taken into account for the clinical evaluation referred to in Article 61 and Part A of Annex XIV of MDR and in the risk management referred to in Section 3 of Annex I of MDR. If, through the PMCF, the need for preventive and/or corrective measures has been identified, the manufacturer shall implement them.

When to conduct PMCF studies for medical devices in Europe:

PMCF studies are designed to identify the potential for residual risks of a CE Marked device, and to collect data and gain clarity regarding the long-term clinical performance of the product.

Circumstances that may require PMCF studies include, but are not limited to:

To confirm the safety and/or clinical performance for a new indication for use or claim that has been CE-certified (approved).

Significant changes have been made to the medical device or labeling, and your Notified Body agrees that no pre-CE-marking study is necessary

Risk classification of the device has increased

Post-market surveillance activities have raised questions about safety, clinical performance, or effectiveness

If pre-CE-marking safety and clinical performance study did not or could not sufficiently address certain aspects

On request from your Notified Body or regulatory authority

The Design of PMCF Activities

Example of methodologies / source of information that can used to collect information for the PMCF are:

Device Registry

Specific PMCF studies

Real-world evidence

Surveys

A review of relevant retrospective data from patients previously exposed to the device

The extended follow-up of patients enrolled in premarket investigations

Post Market Clinical Follow Up Report

The MDR does not include detailed requirements on the contents of the Post Market Clinical Follow up report. However, the MEDDEV 2.12/2 rev 2 – focuses on PMCF activities and gives some detail about requirements for PMCF Reports.

The PMCF report shall include all the information requested as per the related PMCF plan, introducing findings from the investigation at relevant points.

Moreover, it is essential that post-market clinical follow-up report, in case a specific PMCF study was conducted, is addressing as well:

Finally, it is also necessary to explain the PMCF report whether the activities performed have been sufficient to address the full range of objectives specified in the plan.

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