Part B of Annex XIII of the IVDR outlines the requirements for Post-Market Performance Follow-up (PMPF) of your in vitro diagnostic device (IVD).PMPF is a continuous process for updating the performance evaluation and an integral part of Post-Market Surveillance (PMS). The purpose of PMPF is to confirm performance, safety, and scientific validity, to ensure the acceptability of the benefit-risk ratio, and to identify newly emerging risks. As a manufacturer, you are therefore required to prepare both a PMPF Plan and a PMPF Report.We help you set up and implement your PMPF process in full compliance with the IVDR - Get in touch today!
PMPF is:
- part of the PMS system; all activities are described in the PMPF Plan.
- a continuous process that updates the performance evaluation.
- the assurance of ongoing safety and performance of an IVD after it has been placed on the market.
- regulated in Annex XIII, Part B of the IVDR.
Our services in this field
To prepare successfully for the future, it takes more than expertise in performance evaluation – it also requires the knowledge and experience to design and implement an individual and appropriate PMPF strategy for your product.Our offer
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- Development of a suitable strategy to generate all required data with minimal effort,
- Support in creating PMPF processes and plans,
- Guidance in the successful implementation of PMPF activities and their documentation in the PMPF Report,
- Support in cost-efficient data collection of performance data through user surveys (general aspects of use / general clinical performance data / addressing specific clinical endpoints).
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Market surveillance and vigilance: What are the differences to PMPF?
Market surveillanceMarket surveillance refers to activities and measures taken by the competent authorities to verify and ensure that the IVD medical devices comply with the requirements of the regulations. The responsibilities are defined in Article 88 of the IVDR. Each competent authority must draw up an annual surveillance plan. The national plans should be drawn up as part of a European market surveillance program and coordinated by the Medical Devices Coordination Group (MDCG).
VigilanceVigilance means the reporting of serious incidents and safety corrective actions to the competent authorities by manufacturers. Manufacturers must also report trends of expected undesirable side effects and incidents that are not classified as serious. Vigilance is a reactive process. It is described in Article 82 of the IVDR, which also defines the deadlines for reporting, depending on the seriousness of the incident.