Post Market Clinical Follow Up
A post market clinical follow up strategy defined in a manufacturer’s PMS and PMCF plan is critical to staying in compliance with the new Medical Devices Regulation (MDR 2017/745). Contact us to understand how to plan a PMCF study and to find out what notified bodies, expect from the manufacturer.
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Post Market Clinical Follow Up
Post Market Clinical Follow Up is an important technical document that outlines a method for conducting PMCF on a medical device. A PMCF Plan must be submitted for regulatory approval of devices. PMCF can sometimes require you to conduct additional clinical investigations, called PMCF studies.
PMCF is an active collection of data on clinical experience with medical devices aftermarket release. These activities can range from an analysis of data from existing device registrations to performing a new clinical investigation. The purpose of PMCF is to confirm the clinical performance and safety of the device in real-world use and help manufacturers manage acceptable risk.
MDR PMCF is a part of the PMS activities and is understood to be a continuous process that updates the clinical evaluation. It must be carried out following the CE marking of a device.
The manufacturer should collect clinical data from the use in or on humans after it has been commercialized or put to service within its intended purpose as referred to in the relevant conformity assessment procedure. MDR PMCF should be done to confirm 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 based on fact-based evidence.
The manufacturer must analyze the findings of the Post market clinical follow up and record the results in the clinical evaluation report and the technical documentation. For class III and implantable devices, the clinical evaluation report must be updated at least annually.
PMCF Plan For Medical Devices
The Medical Device Regulation (EU) 2017/745 (MDR) considers the PMCF as a continuous process that updates the clinical evaluation and that shall be addressed in the manufacturer’s post-market surveillance plan. The PMCF plan shall be part of the Post Market Clinical Follow Up plan. As per MDR, the plan must include, at least:
- Identify the requirements and select the device for PMCF, specific procedures, and methods
- Provides a well-defined post market clinical follow-up Plan and supports the development
- Review the data entered in the post market clinical follow up plan to meet the chosen objective.
- Choose the suitable method as per the characteristics and type of medical device.
- Provides a well-defined PMCF study and report templates.
- Verifies the findings and the results based on the activity chosen by the manufacturer.
- Identify 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 scientific literature;
- Specific methods and procedures of PMCF to be applied, that is the evaluation of suitable registers or Post-market clinical studies;
- Rationale for the appropriateness of the methods and procedures referred to in the above-mentioned points;
- Reference to the relevant parts of the clinical evaluation report and the risk management;
- Specific objectives to be addressed by the PMCF report;
- 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 schedule for PMCF activities (e.g. detailed examination of data and reporting) to be undertaken by the manufacturer.
Systematic PMCF Plan Requirements
As per the EU MDR2017/745, 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 post-market clinical follow-up, the need for preventive and/or corrective measures has been identified, the manufacturer must implement them.
As per MEDDEV 2.12/2 Rev 2, the clinical evaluation documentation must be actively updated with the data obtained from PMS. Where medical device PMCF is not deemed necessary, this must be duly justified and documented (Exemption).
MDR 2017/745 PMCF Report for Medical Devices
Annex XIV Part B of the MDR contains detailed guidelines for the PMCF Plan. The post market clinical follow up must be carried out in accordance with a documented post market clinical follow up plan, which must be presented as part of the medical device technical documentation. Findings from PMCF must be summarized on a regular basis in a PMCF Report.
The conclusion of the PMCF report also becomes part of the device’s Clinical Evaluation Report (CER). The contents of the Post market clinical follow up record are explained in MedDev 2.12/2 rev 2 even though it does not modify for MDR.
The important objectives of post market clinical follow up are the following
- Device Adverse events
- Severity and probability of occurrence of Side-effects
- Possible misuse of the device
- Safety and performance of the device in routine use
The above generated date is summarized and recorded. The post market clinical follow up report should also contain a summary of methods followed to collect the data. The manufacturer must justify the Post market clinical follow up activities carried out is sufficient to address the objectives specified in the PMCF plan. The findings of the PMCF shall be analyzed by the manufacturer who shall document the results in a PMCF evaluation report. The PMCF evaluation report shall be part of the clinical evaluation report and the technical documentation.
Are you planning to obtain CE Certification through a Notified Body? Contact us. We specialize in Technical Documentation and Clinical Evaluation covering medical device PMCF.
Frequently Asked Questions
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. pediatrics, elderly;
- High product-related risk e.g. based on design, materials, components, invasiveness, and 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.
What is the use of the Post Market Clinical Follow Up study data?
- The data and conclusions derived from the Post Market Clinical study are used to provide clinical evidence for the clinical evaluation. This may result in the need to reassess whether the device continues to comply with the General Safety and Performance Requirements (GSPR). Such assessment may result in corrective or preventive actions, for example, changes to the instructions for use/labelling, changes to manufacturing processes, revision of the device design, or public health notifications.