PMCF: Post-Market Clinical Follow-up

According to the EU MDR requirements, manufacturers must do periodic checks and follow-ups on the device’s performance after placing a medical device on the market. This is included in the post-market surveillance system.

The function of the post-market surveillance plan is to ensure that medical device manufacturers conduct a thorough assessment of their device performance in real life compared to an ideal clinical situation and to enforce stricter patient safety measures.

The regulation, especially the newest additions, also harmonizes post-market reports of manufacturers all over the EU. This allows the government regulatory authorities to standardize the quality of medical devices effectively.

What is PMCF?

The PMCF or post-market clinical follow-up is a study done regularly as part of the required post-market surveillance.

According to the EU consolidated text published in 2021, with most of the regulations in effect now, post-market surveillance is defined as,

“all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions.”

As we can see from the definition, the goal of the post-market surveillance process is to ensure that manufacturers take preventive and corrective actions with the required vigilance.

The PMCF, according to the MDR, is a continuous process that updates the clinical evaluation data. The process involves actively collecting clinical data from the user’s end. The manufacturer must then evaluate this data based on the device’s intended purpose, as mentioned in the conformity assessment or CER. The goal is to ensure that the device is regularly updated and that the efficiency and safety of the device remain standard throughout its life span. This study also functions as a tool for continuous risk detection, allowing manufacturers to adjust device design as needed.

Aim of PMCF

The goal of the PMCF study is continuous quality control and update. However, while planning the PMCF, manufacturers must conduct the PMCF studies keeping these aims in mind.

The PMCF aims to collect clinical data which will be used to:

Ensure the safety and clinical performance of the medical device during its lifetime.
Identify and prevent any possible risks. This is done by gathering factual evidence regarding the device.
Identify any previously unknown risks and side effects that can affect the outcome of the device usage. The PMCF study should monitor known contradictions and side effects and follow any fluctuations.
Assess the conformity to Annex I: sections 1 and 9. According to these sections, the benefit-risk ratio should be up to a certain standard.
To identify any systematic misuse or unapproved use of the device that does not match the intended purpose. (PMCF can benefit the manufacturer if a new use of the device is identified).

While the aims protect the patient’s rights to safety, they also benefit the manufacturer. A sound and regular PMCF helps the manufacturing company avoid unwanted incidents and potential lawsuits while opening market expansion and device upgrade possibilities.

PMCF Plans

The PMCF study, similar to other post-market surveillance steps, must be planned. A detailed plan must be submitted along with other technical documentation with the clinical evaluation plan.

The PMCF plan should include the following:

Generic ideas of methods and procedures could be applied in the PMCF study. This may include procedures for collecting clinical experience, user experience and feedback, scientific literature screening, and screening of all other clinical data sources.
List of specific methods and procedures to be used in the PMCF study. For example, Assessment of appropriate registers/PMCF studies.
A defense for the suitability of the procedures and methods mentioned in numbers 1 and 2.
List of reference materials regarding the relevant sections of the CER as mentioned in Section 4 and regarding the risk management discussed in Section 3 of MDR Annex I.
Mention definite objectives to be achieved by the PMCF.
Assessment of clinical data regarding clinically equivalent or similar devices.
Reference materials should also be included. Reference includes relevant CS, harmonized standards (if the manufacturer has used them), and PMCF study guidance documents.
Lastly, a realistic, comprehensive, and justified timetable of the PMCF activities involving significant steps of the submitted plan by the manufacturer. For example, the expected PMCF data analysis and report submission time should be stated.

Devices that Require PMCF

The PMCF is included in the clinical evaluation, so it is mandatory for all devices, regardless of risk class. Even the devices that do not have any intended purpose, a PMCF is necessary.

PMCF Schedule

PMCF is a continuous process. The follow-up study is conducted for regulatory and marketing purposes. Thus, it has to be undertaken at regular intervals.

According to the MDR,

“The clinical evaluation and its documentation shall be updated throughout the life cycle of the device concerned with clinical data obtained from the implementation of the manufacturer’s PMCF plan in accordance with Part B of Annex XIV and the post-market surveillance plan referred to in Article 84.”

PMCF Activities

As the PMCF acts to update the clinical evaluation data, specific methods, and systems should be set in place as the device is placed on the market for effortless data collection.

There are several ways of collecting data. The most common ones for medical devices are:

End-user feedback (layperson and medical personnel)
Scientific literature and other sources.

Another way is to research the safety and performance of the medical device actively. This can be done through clinical trials and registry studies.

PMCF Conclusion

According to the MDR, the results of the PMCF are summarised into an evaluation report which is used for

“the clinical evaluation referred to in Article 61 and Part A of this Annex and in the risk management referred to in Section 3 of Annex I. “