Post Market Performance Follow Up

Post Market Performance Follow Up (PMPF) is a continuous process that updates the performance evaluation outlined in Article 56 and Part A of Annex XIII. The post-market performance follow-up is intended to confirm the device’s safety, efficacy, and validity throughout the device’s expected lifetime after it has been marketed and to ensure that the benefit-risk ratio remains acceptable and that emerging risks are identified using factual evidence. PMPF must be performed using a documented method outlined in a PMPF plan.

Post Market Performance follow up is necessary to confirm the device’s safety and performance throughout its expected lifetime. To identify risks that were previously unknown, performance limitations, and contraindications. To identify and analyse emergent risks based on factual evidence. To ensure the continuous acceptability of the clinical evidence and the benefit-risk ratio mentioned in Sections 1 and 8 of Chapter I of Annex I, and to detect potential systematic misuse.

The following aspects should be considered when conducting PMPF:

• PMPF plan
• General methods and procedures of PMPF, such as collecting user feedback forms, analysing complaints for further improvements, scientific literature, and other sources of performance or scientific data.
• Specific methods and procedures of PMPF, such as ring trials and other quality assurance activities, epidemiological research, the evaluation of appropriate patient or disease registers, genetic databanks, and post-market clinical performance studies.
• A justification for the suitability of general or specific methods and procedures.
• A reference to the relevant sections of the performance evaluation report (Annex XIII, Section 1.3) and risk management (Annex I, Section 3).
• The PMPF’s specific objectives.
• An evaluation of performance data for equivalent or similar devices, as well as state-of-the-art.
• Reference to any applicable CS, harmonized standards when applied by the manufacturer, and relevant PMPF guidelines.
• A detailed and well-justified schedule for PMPF activities, such as data analysis and reporting.
• The manufacturer must analyse the PMPF findings and document the results in a PMPF evaluation report that will be used to update the performance evaluation report and as part of the technical documentation.
• If the PMPF identifies the need for preventive and/or corrective measures, the manufacturer must implement them
• IVDR requires ongoing reporting in the form of PMPF Report

A rationale must be included and recorded in the performance evaluation report if PMPF isn’t considered to be appropriate for a particular device

Consultants offer continuous support and guidance to ensure compliance with IVDR regulations. Such as assisting with regulatory submissions, addressing regulatory queries, and managing modifications as per regulatory requirements.

In order to maintain the safety and efficacy of in vitro diagnostic medical devices (IVDs), consultants assist manufacturers in identifying and addressing potential risks related to post-market performance. They can also assist in the development of risk management strategies and mitigation measures