PMCF Plans

Post Market Clinical Follow (PMCF) up is a continuous process, mandated by Medical Device Regulation. The regulation specifies the manufacturers responsibility to proactively collect and evaluate clinical data with the aim of confirming the safety and performance of the device throughout its expected lifetime.

CONTINUOUS PROCESS

PROACTIVE COLLECTION AND EVALUATION OF CLINICAL DATA

CONFIRM SAFETY & PERFORMANCE

THROUGOUT DEVICE LIFETIME

How does PMCF change under EU-MDR?

Annex XIV, Part B of EU-MDR addresses the questions raised by PMCF:

  • Confirming the safety and clinical performance of the device throughout its expected lifetime – conditions under which the device is used may change over time, new diseases may develop, etc. The device must remain safe and perform as intended, even with moving goal posts. Technology or devices that have been on the market for a long time are especially vulnerable.
  • Identifying previously unknown side-effects and monitoring the identified side-effects and contraindications. New devices that see a rapid acceptance on new markets require proper monitoring.
  • Identifying and analyzing emerging risks on the basis of factual evidence where incident reports of the subject device only provide information about that specific device, incident reports of similar devices may help eliminate or mitigate risks before they manifest.
  • Ensuring the continued acceptability of the benefit-risk ratio referred to in Annex I, sections 1 & 9.
  • Identifying possible systematic misuse or off-label use of the device with the intent to verify that the intended purpose is correct.
who audits CER

Where do the PMCF activities lie in the lifetime of a medical device?

How does PMCF change under EU-MDR?

clinical evaluation report

Is PMCF necessary for all medical devices?

  • Yes, under MDR, PMCF is required for all medical devices.
  • EU-MDR requires that all Manufacturers have a PMCF plan that will define whether a PMCF study or other PMCF activities (e.g. surveys, data from device registries, IITs, manufacturer-initiated investigations, clinical data retrieved from literature) will be implemented.
  • Therefore, the minimum requirement is a justification in the PMCF plan as to why performing PMCF activities will not be necessary, i.e. how a Manufacturer intends to achieve to proactively collect sufficient clinical data in post-marketing context in order to feed/update the clinical evaluation report (see Annex II, section 6,1, point (d); Annex III, section1.1., point (b); Annex VII: section 4.5.5)

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