Post-Market Clinical Follow-up Plan

How to plan your Medical Device Regulation (MDR) Post-Market Clinical Follow-up (PMCF) evidence generation strategy.

What is a Post-Market Clinical Follow-up (PMCF) Plan?

A PMCF Plan is an important technical document that outlines a method for conducting Post-Market Clinical Follow-up on a medical device. PMCF, in turn, is the process of proactively and constantly collecting clinical data in order to demonstrate that a CE-marked medical device’s safety and performance is in line with expectations.

The Medical Device Regulation (MDR) 2017/745 greatly increases the importance of PMCF and outlines a detailed procedure for conducting PMCF in Annex XIV Part B. A specific requirement is that all manufacturers document a PMCF Plan to detail the process that will be followed in collecting PMCF data on each of their medical devices. A PMCF Plan must be submitted as a component of the Annex II technical documentation dossier required for regulatory approval of devices under the MDR.

What are the requirements for developing a PMCF Plan?

MDR Annex XIV Part B requires that a PMCF Plan must outline a detailed method for conducting PMCF. The PMCF Plan must specify how it will:

  • Confirm safety and performance of the device throughout its expected lifetime
  • Identify previously unknown side-effects
  • Monitor the rate and severity of known side-effects
  • Identify and analyse any emergent risks
  • Ensure continued benefit-risk acceptability
  • Identify any systematic misuse or off-label use

A PMCF Plan should be written in consultation with a clinical expert who has experience in designing clinical studies of the required standard. It should be remembered that a PMCF system must be capable of capturing data on use of a medical device throughout its entire lifetime, ruling out most standard-type clinical investigation designs.

The best PMCF Plans outline a method for generating Real World Evidence (RWE) that provides data on real, undifferentiated use of the product in the hands of genuine users “out there in the world”. Standard clinical investigations tend to be too restrictive to meet requirements for PMCF under the MDR and will not run for a sufficient length of time to meet requirements for longitudinal data collection.

A Medical Device Registry is a very advantageous form of PMCF system that provides a single central repository of PMCF data captured from any number of different territories. Properly designed, a product registry ensures that data is generated in a consistent manner in compliance to a study protocol, and also ensures adherence to wider rules and regulations including the requirements for clinical investigations in Annex XV MDR.

Real World Evidence generation systems require specialist knowledge but can pay huge dividends through ensuring ongoing availability of data to support regulatory approval of a medical device throughout its commercial lifecycle.

The PMCF Plan must include at least:

  • Details of general methods to be applied, e.g. gathering clinical data, user feedback and/or literature searching
  • Specific methods to be used, e.g. medical device registry
  • Rationale for chosen general and specific methods
  • A reference to relevant parts of the Clinical Evaluation Report (CER) that contain a summary of PMCF data, an appraisal of the PMCF system, and results of data analysis.
  • Specific objectives addressed by PMCF
  • Evaluation of clinical data from equivalent/similar devices, if relevant
  • Reference to any harmonised standards used in developing the PMCF Plan
  • Timescale of PMCF activities

It is important to account for all relevant laws and regulations when developing a PMCF Plan. In particular, the General Data And Performance Regulations (GDPR) establishes a strict set of standards for handling study subject’s clinical data, and the PMCF Plan should establish procedures for ensuring that the requirements of this Regulation are adhered to.

Furthermore, it is important to consider whether PMCF activities may require ethical approval before data collection can commence. Requirements for ethical approval vary between different EU Member States so it is important to understand local requirements and ensure that the PMCF Plan incorporates procedures for meeting obligations.

What other guidance is available for writing a PMCF Plan?

The European Commission publishes a range of MEDDEV guidelines to assist manufacturers in meeting medical device regulatory requirements. MEDDEV 2.12/2 rev 2 “Post-Market Clinical Follow-up Studies - A Guide for Manufacturers and Notified Bodies” contains useful guidance for writing a PMCF Plan.

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