Does my medical device need a PMCF system for MDR compliance?

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Matthew Stinson

Post-Market Clinical Follow-up (PMCF) has assumed greater importance under the EU MDR than ever before. PMCF calls for the ongoing collection of safety and performance data throughout the commercial lifetime of a medical device, generating evidence on real-life experience with the product.

Understandably, some manufacturers are unclear whether a PMCF system needs to be implemented for their device and may prefer not to develop one unless absolutely necessary. This is particularly the case for legacy products with existing data, or with low-risk devices for which development of a bespoke PMCF system may at first glance seem unnecessary.

However, exceptions to the requirements for dedicated PMCF systems under the EU MDR are limited. It’s vital that all relevant device characteristics are considered in detail before forming conclusions.

Rapid PMCF Checker

The good news is that we have made the decision-making process easy for you. We have just launched our unique online PMCF Checker. Answer ten simple yes/no questions in a few minutes and our PMCF Checker will show you whether or not your device requires a dedicated PMCF system according to the rules in the EU MDR. Try it out:

Is PMCF required for my medical device?

Answer 10 quick questions to find out:

Question 1 / 10 Is your device a new or novel product, which doesn't have substantial clinical evidence demonstrating safety and performance?

Question 2 / 10 Was the clinical evidence relating to your medical device collected many years ago? (i.e. no recent clinical studies or substantial data collection exercises)

Question 3 / 10 Does available clinical evidence leave some data gaps relating to the device's indications and/or target patient populations?

Question 4 / 10 Have there been any important changes to the medical device, its label and packaging, or its IFU since it was CE-marked?

Question 5 / 10 Has your Notified Body asked you to develop a PMCF system?

Question 6 / 10 Has a new indication or change to intended purpose been introduced since CE-marking?

Question 7 / 10 Has the risk classification of your device changed?

Question 8 / 10 Have risk management activities or clinical evaluation identified any new, emergent or unmitigated risks in relation to the device?

Question 9 / 10 Have PMS activities led to questions about the safety, performance or suitability for purpose of your device or similar devices on the market? (including SAEs, FSCNs or CAPAs)

Question 10 / 10 Is the device high-risk? (in terms of the nature of the device, medical indication, target patient population or substances used in the device)

It looks like you will need a PMCF system for your medical device

It looks like you don't need a PMCF system for your medical device *

Failure to implement an appropriate PMCF system may result in loss of MDR regulatory approval and CE-marking.

It is therefore essential to ensure that any PMCF system is well-constructed and suitable for its intended purpose. Our expert team offer a complete PMCF advisory and design service dedicated to ensuring compliance with all MDR requirements.

Complete the form and our medical team will contact you to discuss your PMCF situation further.

Please note that this may change for your medical device if you:

  • modify its intended purpose
  • change its risk profile
  • alter its indications
  • change its target patient population
  • are advised otherwise from a regulatory body

If you'd still like to speak to us about your PMCF, please complete the form and our medical team will be in touch.

* Disclaimer: Outputs from this tool are indicative only and do not constitute formal advice. Mantra Systems Ltd accepts no responsibility for any party's interpretation of, or application of, results of this tool.

Alternatively, you can call +44 114 299 2599 or email us to discuss this with our medical team.

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