What is the Post-Market Clinical Follow-up?

The EU MDR a new and updated set of regulations has given many challenges to manufacturers and other parties in the medical sector. Now all medical devices require CE labelling by the manufacturers before selling them in the European Market. This regulation emphasis more on device safety, post-market monitoring, and clinical follow-ups. This requires manufacturers to not only focus on device safety but also they have to maintain device clinical data until its lifecycle.

Post Market Clinical Follow Up

According to the medical Device coordination group, PMCF is a regular process that updates CE and will be updated in the Post Market Surveillance program by the manufacture. Basically, post-market clinical follow-up is in the PMS plan that guides manufacturers to collect and evaluate the clinical data of CE-marked devices properly. The aim of PMCF is described as below:

• Confirming safety and performance of the device with clinical benefit if there is any.
• Monitoring and identifying unknown side effects and contraindications
• Analyzing and identifying rising risks on the basis of real proofs.
• Guaranteeing the continued acceptability of the benefit-risk ratios
• Identifying misuse and off-label misuse of the device with a view to verify that the intended purpose is right.

What Factors Determine The Need For PMCF?

• Whether instruction on the device supports adequate clinical evidence or not.
• If the device involves any risk factor for the medical condition it is being used for.
• Whether the device involves high-risk anatomical location or not
• Is there sufficient clinical evidence to support the use of the medical device in the areas of a high-risk population?
• Does the device have novel features?
• Are there any updates on a particular device in terms of nature, medical conditions, materials, substances, etc?

Compiling Evidence Of PMCF Via End-User Surveys

There are a number of ways and strategies to compile the evidence for PMCF. Some of them are random clinical trials (RTC), literature reviews, retrospective patient record reviews, end-user surveys, focus groups, and registry studies. Figuring out which measure to take depend on the level of evidence required and the time and efforts put together to collect this evidence. While RTC and registry, studies give a high level of evidence so it is often time-consuming and expensive. On the other hand, an end-user survey gives usually fewer pieces of evidence. Hence PMCF with End User surveys require less time and lower cost to compile the evidence. The evidence for End-user surveys depends on the type of device used including the device’s previous data and risk classifications. These are then used with PMCF methods to strengthen the evidence of data for types of risks involved with the device.

Ways To Implement End-User Surveys With PMCF

In order to run an end-user survey, that medical device manufacturers need to consider are:

• End-User Information - Specialty type, screening criteria
• Device Type - Name of device, therapy area, and risk classification
• Sales Information - Unit of the device sold in a specific region or country
• Sample size requirement - recording sample size used depending on the type of device and sales volume
• Safety tips - providing safety information that can be taken from the IFU or CER and some used during the survey.
• Performance features - any performance information that is collected or tested from the survey

Once all this information is collected from the survey. This result is then required to analyze and interpret before preparing the PMS and PMCF MDR templates.

Conclusion

As a manufacturer, you must understand that before selling any device you have to comply with all guidelines of MDR including PMS report, CE report, or PMCF report, etc. So make sure you have prepared everything to comply with EU MDR.