PMCF Studies, Surveys & Plans

Powerful medical device Post-Market Clinical Follow-up systems designed by medical experts for EU MDR compliance

Our PMCF services

An effective Post-Market Clinical Follow-up system is an essential component of many regulatory frameworks under the MDR. We handle all aspects of PMCF system design and documentation while our curated EDC systems ensure simple, point-of-use data collection.

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.

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

* 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.

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

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

Alternatively, you can call (+44) 0114 386 3349 to discuss this with us.

  • PMCF Study Survey & Plan design

    Complete PMCF systems designed for your medical devices and built on MDR requirements.

  • Medical & Technical Document Writing

    PMCF Reports, Study Protocols & Evaluation Reports, Investigator's Brochures, ICFs & PILs.

  • Clinical site on-boarding & initiation

    Dedicated support to ensure efficient and effective clinical site activation.

  • Clinical data collection & storage

    PMCF eCRF & ePRO systems enabling GDPR-compliant data collection from any device.

  • Automated‚Ä® analysis & reporting

    Continuous, automated data monitoring & reporting throughout the entire lifetime of a device.

  • Study‚Ä® maintenance

    On-going PMCF Study & Survey maintenance with adaptive clinical site engagement.

Start today

Our in-house medical professionals have extensive experience developing tailored PMCF systems. Start by talking with us so we can fully understand your needs.

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