Medical Device Regulation Resources for the UK & EU MDR

Gain understanding of medical device regulation through our library of exclusive resources

Sandra Gopinath, Chief Regulatory Officer

  1. An EU flag

    EU MDR Compliance Guide

    Our free EU MDR Compliance Guide covers 24 topics relating to Medical Device Regulation. Combined with our other online resources, it's a great starting point to help direct your regulatory strategy.

    • Post-Market Surveillance
    • Risk Management
    • Quality Management Systems
    • Clinical Evaluation
    • Plus 20 other topics
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  2. AI-powered MDR and MDCG chatbot by Mantra Systems

    EnableChat

    If you find it difficult finding MDCG documents and MDR articles, try asking our AI-powered chatbot your regulatory questions and you'll get an answer back in seconds.

    • Search the MDR & MDCG Guidelines
    • Ask a question in any language
    • Get an answer in seconds
    • No sign-up, it's FREE
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  3. A woman taking an EU MDR Training Courses using Document Templates

    EU MDR Strategy Toolkit

    Do it once and do it right with our EU MDR training courses and fill-in-yourself document templates. Gain confidence, reassurance and control over your regulatory strategy.

    • CER + CEP Templates & Writing Course
    • Understanding the EU MDR Training
    • Risk Management + Annex II Templates
    • Gap Analysis Tool
    • Free MDReady Starter Guide
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  4. A library of Medical Device Regulation White Papers

    White Papers

    Our free White Papers will help you understand important areas of the medical device regulatory environment.

    • Mastering the MDR
    • PMS in the MDR
    • Software as Medical Device
    • More coming soon
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  5. A woman reading & taking notes on a Medical Device Regulation article

    Articles & News

    Read our analysis and get guidance on medical device regulatory requirements including our observations on developments in the industry.

    • PMCF strategies
    • Regulatory compliance guidance
    • Clinical Evaluation best practice
    • Future of the UK & EU MDR
    • Plus many more subjects
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  6. Using the PMCF Checker

    PMCF Checker

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

    • Answer 10 quick questions
    • Get clarity about your PMCF obligations
    • Takes just a few minutes
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MDReady Starter Guide A simple, comprehensive and free guide to working with the EU MDR.

Free download — MDReady Starter Guide Free Download