Clinical Evidence Generation

PMCF systems & clinical investigators for medical device regulatory compliance

An effective PMCF (Post-Market Clinical Follow-up) system is essential for ongoing approval of most medical devices under the EU MDR.

We design & initiate PMCF systems to generate clinical evidence

  1. PMCF study / survey design and implementation, fully compliant with EU MDR requirements.
  2. GDPR-compliant data collection and secure storage using online eCRF & ePRO systems, enabling real-time data input from any device.
  3. Lifetime monitoring of device usage with automated clinical data generation & reporting used for Clinical Evaluation and other areas of your MDR strategy.
  4. On-going PMCF system maintenance with adaptive clinical investigator management.
  5. Medical document writing including PMCF plans, reports, study protocols & evaluation reports, investigator's brochures, ICFs & PILs.

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What our clients say

All aspects of communication from Mantra Systems have been excellent from initial contact to the conclusion of the projects. There was excellent communication during the projects, included reviews and discussions helping to maintain the momentum and provide the required outcomes.

The work was performed to excellent standards with every part surpassing expectation. The final reports were of an impeccable standard that I am incredibly confident using going forward as part of my technical files.

DS

Regulatory & QA Manager Medical Device Manufacturer, UK

Unsure whether you need PMCF?

Our PMCF Checker is a quick test to see if your medical device needs a PMCF system for regulatory compliance.

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) 0114 386 3349 or email us to discuss this with our medical team.

Free PMCF Audit

We offer a free PMCF audit service where we review your existing Post-Market Clinical Follow-up system and produce a comprehensive report with guidance and advice. We audit:

  • Study / Survey design protocol

  • PMCF Plans and other documents

  • Reporting and analysis mechanisms

  • Data collection & handling processes

  • Adverse Event capturing

  • Alignment with Meddev & MDCG guidelines

Please contact a member of our team to discuss this service in more detail.

Clinical Investigators & Sites

Our database of pre-approved clinical sites and investigators means we can match your devices with motivated investigators interested in conducting PMCF studies.

  • Extensive database of clinical investigators

  • Pre-approved for PMCF studies

  • Rapid on-boarding & study initiation

  • Access to a broad range of clinical sites

Visit Clinical Investigators

Start today

Our extensive clinical evidence generation experience will enable us to develop the PMCF system your medical device needs for regulatory compliance.

Start by talking with us so we can fully understand your requirements.

Your privacy is important. See how we handle your data.

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