A new concept: PMPF becomes mandatory under the IVDR

Part B of the new IVDR Annex XIII deals with the post-market phase and describes the requirements for tracking post-market performance. PMPF is another new term that does not appear in the current IVDD. But what does it mean?

PMPF (post-market performance follow-up) refers to the concept that you must continuously review the performance evaluation report to ensure that it reflects the current state of the art. As a manufacturer, you are required to prepare both a PMPF plan for post-market performance and an assessment report (PMPF report) for post-market performance follow-up.
PMPF is an important element of PMS (post-market surveillance).

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In short: PMPF...

  • is part of the PMS system; all activities are described in the PMPF plan.
  • is a continuous process and part of performance evaluation.
  • builds a bridge between the evidence collected at pre-market stage and PMS data.
  • is regulated in Annex XIII Part B of the IVDR.
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  • Developing a relevant strategy how to generate all necessary data,
  • Supporting the development of PMPF processes and plans and
  • Helping with the successful implementation of PMPF activities

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Market surveillance and vigilance: What are the differences to PMPF?

Market surveillance
Market surveillance or observation, 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).

Vigilance
Vigilance 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.

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