Answer 10 quick questions to find out:
PMCF Checker
See whether Post-Market Clinical Follow-up is required for your medical device
Is PMCF required for my medical device?
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 *
We would advise you to start investigating your PMCF requirements. Our expert team offer a complete PMCF advisory and design service, dedicated to ensuring compliance with all MDR requirements.
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
Contact us today and our specialists will be in touch to discuss your PMCF requirements.
If you'd still like to speak to us about your PMCF situation, please contact us and one of our specialists 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.