How To Write A PMCF (Post-Market Clinical Follow-up ) Plan
Post-Market Clinical Follow-up or PMCF refers to activities that help provide data, documentation, and evidence regarding a medical device’s safety or performance. PMCF is one component of post-market surveillance (PMS) activities for medical devices. The purpose of PMCF is to confirm the clinical performance and safety of the device in real-world use and help manufacturers manage acceptable risk. PMCF and PMS data safety and performance data collected from real-world device usage are expected to feed back into a re-evaluation of Risk determination over the life cycle of the device.
As experts in the field, we at Trinity M Consuting, LLC want to help you understand how to write a PMCF Plan. This is why we have written down information that would aid you in the process.
Medical device manufacturers must outline their PMCF process in a plan and document their PMCF findings in an evaluation report. A PMCF Plan is an important technical document that outlines a method for conducting Post-Market Clinical Follow-up on a medical device. A PMCF Plan must be submitted for regulatory approval of devices under the EU MDR as a component of the MDR Annex II technical documentation.
MDR Annex XIV Part B Requires That A PMCF Plan Must Provide A Detailed Summary Of A Method That Will:
- Confirm the 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 analyze any emergent risks
- Ensure continued benefit-risk acceptability
- Identify any systematic misuse or off-label use
Writing A PMCF Plan Involves Two Stages:
PMCF System Design - A PMCF system must be designed to meet the needs of the subject device before a PMCF Plan can be written.
PMCF Plan Structure - Once designed, the PMCF system must be documented in a PMCF Plan that is structured according to MDR requirements.
PMCF System Design
A PMCF system design should be tailored to the subject device and its associated classification and complexity. Effective PMCF systems are built to address risk management outcomes alongside the overall objectives for PMCF as specified in the MDR. A PMCF system must be capable of capturing data on the use of a medical device throughout its entire lifetime, meaning that many standard-type clinical investigations will not be suitable for this application.
PMCF systems can range from a simple patient or end-user surveys to formal clinical investigations and complex medical device registries that incorporate both clinical and patient-feedback data. All clinical investigations must adhere to MDR Annex XV requirements on design, documentation, consent, and data handling, as well as external legislation such as the GDPR and standards such as ISO 14155:2020.
Increasingly, manufacturers are advised to develop a PMCF Plan that outlines 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 PMCF study or survey (sometimes known as a ‘medical device registry’) is a sophisticated system that provides a single central repository of PMCF data captured from any number of different territories. Properly designed, a PMCF study/survey/registry ensures that data is generated in a consistent manner under a universal study protocol. It also ensures adherence to wider rules and regulations, including the requirements for clinical investigations in Annex XV MDR. Clinical Evidence Generation systems require specialist knowledge to design and implement. Once established, a well-designed system can pay huge dividends by ensuring the ongoing availability of data to support regulatory approval of a medical device throughout its commercial lifecycle.
PMCF Plan Structure
A well-written PMCF Plan should 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., PMCF study/survey/registry.
- The rationale for selected 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 harmonized standards used in developing the PMCF Plan.
- The timescale of PMCF activities.
While not obligatory, it is advisable to adopt the PMCF Plan structure recommended in MDCG Guideline 2020-7, ensuring that all MDR Annex XIV Part B requirements have been met. A continuous process that updates the clinical evaluation, PMCF is a critical element of the overall PMS plan, which is conducted in accordance with a PMCF plan. PMCF is the process of proactively and constantly collecting clinical data to demonstrate that a CE-marked medical device’s safety and performance are in line with expectations. It is important to account for all relevant laws and regulations when developing a PMCF Plan.
For more information on how to write a PMCF Plan, reach out to Trinity M Consulting, LLC. We are a medical device consulting firm based in Florida, focused on providing exceptional customized services for the Medical Device industry. We take pride in creating a partnership with our clients and delivering excellence. Our experts are experienced professionals in Regulatory Affairs, Medical Writing, and Project Management. Our services are available to clients remotely all over the United States.