Medical Device Regulatory Resources

Our range of resources contain exclusive documents & guidance on all aspects of MDR compliance

  • Downloads Suite

    • MDReady Starter Guide
    • Mastering the MDR White Paper
    • PMS in the MDR White Paper
    • CER Template
    • ... and more

    Our Downloads Suite contains exclusive White Papers, templates, tools & guides that cover important areas of the medical device regulatory environment.

    Get our downloads

  • EU MDR Compliance Guide

    • Post-Market Surveillance
    • Risk Management
    • Quality Management Systems
    • Clinical Evaluation
    • ... and 18 other topics

    Our unique EU MDR Compliance Guide covers 22 topics relating to the new Medical Device Regulation (EU) 2017/745. It's free to use and combined with our online resources it will help direct your regulatory strategy.

    Read our guide

  • MDR Compliance Webinar

    • Understand the key MDR requirements
    • Build an effective regulatory strategy
    • Learn how to apply clinical evidence
    • Access powerful regulatory resources

    Our free webinar gives detailed guidance on building MDR-compliant regulatory systems and processes — delivered live by our medical experts.

    Register free

  • Free MDR Support

    • Talk with a medical expert
    • Free advice about your MDR strategy
    • Arrange a free PMCF audit
    • Discuss our CER review service

    Arrange a free MDR compliance support call with one of our team to discuss your medical device regulatory requirements.

    Get started

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.

Articles

Keep up to date with our thoughts on the industry. You can also find our updates on LinkedIn and Twitter.

  1. PMCF systems for medical devices

    Why you'll almost certainly need a PMCF system for your medical devices

    We tell you what to be aware of under the EU MDR regarding PMCF and your medical devices.
  2. MDR Compliance Webinar - A masterclass on building a winning EU MDR strategy for your medical devices

    Build a winning EU MDR strategy for your medical devices

    Watch our CEO, Dr Paul Hercock, deliver a Mantra Systems webinar on MDR compliance strategy.
  3. Our online PMCF Checker shows if your medical device requires a PMCF system

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

    Answer 10 quick questions to check whether your medical device requires a PMCF system.
  4. Ensure medical device regulatory compliance of your devices through Brexit

    The impact of Brexit on medical device regulatory compliance

    How to ensure regulatory alignment of your devices in the territories affected by Brexit.
  5. Use medical device regulatory consulting services to supercharge your MDR transition

    Is outside consulting support the answer to your MDR transition?

    Getting ready for the MDR is a demanding process. Outsourcing might be your solution.
  6. Increasing data entry compliance in PMCF studies

    Increasing data entry compliance in PMCF studies

    5 methods every medical device manufacturer should know to improve their Post-Market Clinical Follow-up studies.

More articles

MDR Training Academy

The Mantra Systems Academy is the complete MDR compliance support program. Integrating education, training, support, templates and full document management, it will empower your team to implement critical components of your MDR strategy without the need for outsourcing.

Get started with our Academy

  • Risk Management

  • Quality Management *

  • Post-Market Surveillance *

* coming soon

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