CRFWEB INFO SHEET

Post Market Clinical Follow-up (PMCF) as part of Post Market Surveillance (PMS) under MDR

From the Date of Application, 26 May 2021, (DoA) for MDR, manufacturers will have a statutory requirement to collect post market clinical data as a continuous process over the device lifetime with the aims of:

Confirming the safety and performance throughout the expected lifetime of the device
Ensuring the continued acceptability of identified risks
Detecting emerging risks on the basis of factual evidence

Importantly, all existing devices currently on the market in the EU will also need to comply with MDR PMS requirements to retain their existing CE Mark. That will mean manufacturers will need to ensure that their existing PMS system is MDR-compliant or design and implement a new or revised system appropriate for the type of device and proportionate to the risk class. A PMS Plan will be a mandatory element of the Clinical Evaluation Plan (CEP) required for MDR.

It is important to also emphasize that an MDR-compliant PMS system is expected to be fully integrated with the manufacturer’s Quality Management System (QMS).

Post Market Clinical Follow up (PMCF)

PMCF is expected to be required for most devices – new and existing – and is defined as a continuous process that updates the clinical evaluation; the manufacturer is expected to proactively collect and evaluate clinical data from use in or on humans of a device which already bears the CE marking (currently on the market or in service) within its intended purpose. The core aim of PMCF is 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.

PCMF activities are expected to be fully described and defined in a PMCF plan, which in turn will be part of the overall the PMS plan. The PMS plan is, itself, a key element of the Clinical Evaluation Plan (CEP) and so is required for an application for market access.

The aims of the PMCF are:

Confirming the safety and performance, including the clinical benefit if applicable, of the device throughout its expected lifetime
Identifying previously unknown side-effects and monitor the identified side-effects and contraindications
Identifying and analysing emergent risks on the basis of factual evidence
Ensuring the continued acceptability of the benefit-risk ratio, referred to in Section 1 and 9 of Annex I in the MDR
Identifying possible systematic misuse or off-label use of the device, with a view to verifying that the intended purpose is correct.

The findings of the PMCF will be analysed by the manufacturer and the results documented in a PMCF evaluation report. The PMCF evaluation report will be part of the clinical evaluation report and the technical documentation.

The acceptability of the PMCF plan and its application is subject to assessment by the notified body. The notified body’s assessment of the clinical evaluation will also cover the manufacturer’s procedures and documentation of the PMCF.

It is role of the notified body to assess the justification provided by the manufacturer in relation to non-performance of PMCF.

Examples of PMCF-related activities

A manufacturer device registry (specific for the type of device or the group of the medical devices the product belongs to) can be indicated together with a description and a summary of the plan. A pre-specification of what quality and quantity data – based on the risk of the device(s) and the associated accessories – to be collected and analysed shall be included. Any possible evaluation of suitable national public registries with clinical data on the manufacturer’s own device and/or on similar devices could be specified in this section, identifying the expected quantity and quality of data to be gathered and the search protocols to be adopted.
PMCF studies (e.g. extended follow up of patients included in the pre-market clinical investigations, new clinical investigations within the intended use, retrospective studies). In case of implantable devices and class III devices where clinical investigations have not been performed pursuant to Article 61 (4), the PMCF plan shall include post market studies to confirm the safety and performance of the device.
Planned Real-world evidence (RWE) analyses could be indicated in this section, together with a summary of the plan including the design, sample size, the endpoints, and analysis population. The real-world data (RWD) from which these analyses are based on should be of sufficient quality and come from reliable data sources.
Surveys planned to collect information about the use of the concerned medical device could be described. schedule for PMCF activities, such as the analysis of PMCF data and reporting, shall be described.

Post Market Clinical Follow up (PMCF) studies

The purpose of a PMCF study is to examine how your device performs when used as intended so that clinical performance can be verified and to collect safety information.

Under the MDR, manufacturers will be expected to perform more PMCF studies throughout the device lifecycle then under previous regulatory regimes.

Notified Bodies can require a PMCF study at any time if, in their judgement, data provided to support the safety and performance of a product are inadequate or incomplete.

To meets the needs of MDR PMS, a PMCF study will need to be fully compliant with the processes and methodologies set out in the standard ISO 14155:2020.

In reality, the requirements for PMCF studies are closely aligned to those of pre-market clinical study plans. The PMCF study must demonstrate the clinical safety and performance of a device throughout its lifetime when used as intended. However, a PMCF study does NOT need to include randomization, excessive patient selection criteria, or control groups.

When is a PMCF study required?

According to the guidance MEDDEV 2.12-2, and which still provides a useful baseline for MDR, the circumstances under which PMCF may be necessary are as follows:

Innovation: the device’s design, materials, substances, principles of operation, technology or medical indications are novel
Significant changes to the product or to its intended use for which pre-market clinical evaluation and re-certification has been completed
High product-related risk
High-risk anatomical locations
High-risk target populations (e.g., children, elderly)
Severity of disease/treatment challenges
Questions of ability to generalize clinical investigation results
Unanswered questions of long-term safety and performance
Results from any previous clinical investigation, including adverse events or from post-market surveillance activities
Identification of previously unstudied subpopulations which may exhibit different benefit/risk-ratio (i.e., hip implants in different ethnic populations)#
Continued validation in cases of discrepancy between reasonable pre-market follow-up time scales and the expected life of the product
Risks identified from the literature for other data sources or similar marketed devices
Interaction with other medical products or treatments
Verification of safety and performance of device when exposed to a larger and more varied population of clinical users
Emergence of new information on safety or performance
Where CE Marking was based on equivalence

PMCF studies may NOT be required when the medium/long-term safety and clinical performance are already known from previous use of the device or where other appropriate post-market surveillance activities would provide sufficient data to address the risks.

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