Regulation (EU) 2024/1860 - Its impact on EU MDR and IVDR
How does the recent Regulation (EU) 2024/1860 amendment affect the EU MDR & IVDR?
Shona Richardson
Regulatory Medical Writer
Medical Minds for Market Access Medical Device Regulatory Consulting
Expert MDR & IVDR Regulatory Consultants
Mantra Systems provides full MDR & IVDR consulting services to companies worldwide seeking UK / EU market access for any class of medical device.
Our unique network of medically-trained consultants will bring specialised clinical evidence appraisal & analysis to your medical device regulation strategy.
Our Clients say
Mantra Systems provided outstanding quality literature search reports & State of the Art appraisal reports for our medical devices; I would thoroughly recommend them.
TDDr. Trevor Day Principal Scientist Procter & Gamble, UK
Medical Device Regulation Resources
Our Medical Device Regulation Resources contain information and guidance on a wide range of aspects across the regulatory landscape.
For further guidance or any specific enquiries, please contact our specialist consultants.
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EU MDR Compliance Guide
A free Medical Device Regulation guide
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Articles & News
Analysis from our medical writers
MDReady Starter Guide Begin your EU MDR compliance journey with a free step-by-step guide
Our Clients
We serve an international client-base covering all classes of medical device across a wide range of clinical fields.
Our clients are based around the world, hailing from the UK, Europe, North America, Central America, Asia and the Middle East, and vary in size from pre-market start-ups to stockmarket-listed multinationals.
Our Clients say
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Please thank all of your team for their brilliant efforts. Your standard of service, response time, and rigour were outstanding and I would strongly recommend you to any other potential client.
ABQuality Advisor Manufacturer, UK
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Your service surpassed our expectations and added value across our organisation. We feel much better placed to prepare for the MDR.
KWChief Executive Officer SaMD Company, UK
Latest articles
Stay informed with our industry-focused publications. You can also follow our updates on LinkedIn & YouTube.
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Shona Richardson
Regulatory Medical Writer
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MDCG 2024-10 - Orphan medical devices
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A medical device's intended purpose - what is the point?
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EnableChat - Your AI-powered MDR and MDCG chatbot
Search the MDR and MDCG documents in seconds by asking EnableChat your questions.
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Staying vigilant - A guide to searching for adverse events data
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Lead Medical Writer
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What is Summary of Safety and Clinical Performance (SSCP)?
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Sandra Gopinath
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Scientific Validity Reports – Foundation of the IVDR Performance Evaluation
Justifying scientific validity is the first step in proving compliance with the IVDR.
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Mantra Systems at MEDICA 2023
Mantra Systems is going to MEDICA 2023, the largest medical trade fair in the world. We hope to see you there.
Shen May Khoo
Junior Regulatory Specialist
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Medical Device 'Significant Changes' – Navigating EU MDR Article 120(3) using MDCG 2020-3 rev. 1
Understand what changes to your medical device are considered 'significant' under EU MDR (2017/745).
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