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  1. A team of profesional-looking people sit around a table, congratulating themselves.

    Extending the Validity of your IVDD Certificates – Key Dates

    The EU and the MHRA have extended the validity of IVDD certificates, allowing you more time to transition to the IVDR. We explain what this means for manufacturers.

    Kamiya Crabtree Kamiya Crabtree Regulatory Medical Writer
  2. A team of profesional-looking people sit around a table, congratulating themselves.

    GSPR 1: A New Era of Performance with Safety at the Core

    This regulation emphasizes risk management, durable design & biocompatibility to ensure medical devices are safe and effective. GSPR 1 protects users while driving innovation in medical technology.

    Kamiya Crabtree Kamiya Crabtree Regulatory Medical Writer

  3. Cybersecurity Vulnerabilities in Medical Devices: FDA Alerts on Contec and Epsimed Monitors

    Patients can be exposed to risks when devices are online. We explore implications for EU MDR/IVDR cybersecurity requirements, including MDCG guidance

    Dr Clare Dixon Dr Clare Dixon Regulatory Specialist
  4. A futuristic-looking factory full of labelled cardboard boxes.

    Decoding UDI: Your Ultimate Guide to Smarter Medical Device Labelling

    The Unique Device Identifier (UDI) ensures medical device traceability and compliance. We break down its structure, Device Identifier (UDI-DI), Production Identifier (UDI-PI) and its role in EUDAMED.

    Kamiya Crabtree Kamiya Crabtree Regulatory Medical Writer
  5. A scientist uses a pipette to prepare lab samples.

    Understanding Risk-Based Classification of In Vitro Medical Devices Under EU IVDR

    The transition from IVDD replaces list-based classification with a risk-based approach. Manufacturers must thoroughly understand the rules outlined in Annex VIII of the IVDR.

    Dr Gayle Buchel Dr Gayle Buchel Chief Medical Writer
  6. A hospital room full of equipment with futuristic user interfaces.

    IMDRF Sets the Standard: 10 Key Principles for AI-enabled Medical Devices

    Good Machine Learning Practice (GMLP) principles ensure safe devices, covering intended use, clinical evaluation & Human-AI Interaction (HAII).

    Ron Sangal Ron Sangal Lead Medical Writer
  7. A medical team discuss performance data at their desktop computer.

    Key Updates for Navigating EMDN: MDCG 2024-2 Rev.1 & 2021-12 Rev.1

    Release of the updated guidance helps manufacturers navigate the EMDN system for accurate device classification, ensuring market access.

    Ron Sangal Ron Sangal Lead Medical Writer
  8. A lab technician enters samples into a machine.

    From IVDD to IVDR: Ensuring Compliance During the Transitional Period

    Legacy device manufacturers need to manage challenging timelines as well as address transitional provisions and update QMS.

    Shona Richardson Shona Richardson Regulatory Medical Writer
  9. A futuristic user interface is operated at a desk.

    An Overview of the UK’s 2024 Post-Market Surveillance Update

    What might mandatory PMS plans - which emphasise enhanced patient engagement and proactive risk management - mean for the industry?

    Ron Sangal Ron Sangal Lead Medical Writer
  10. A dated monitor for medical equipment.

    Understanding Clinical Evidence Requirements with MDCG 2020-6

    How can manufacturers ensure legacy devices meet MDR's stringent requirements? Discover how MDCG 2020-6 guidance simplifies the path to compliance.

    Dr Clare Dixon Dr Clare Dixon Regulatory Specialist
  11. A stethoscope laid on a desk of regulatory documentation.

    Clinical benefits of an in vitro diagnostic medical device

    How to determine the clinical benefit of an IVD and successfully incorporate it into regulatory documentation.

    Dr Gayle Buchel Dr Gayle Buchel Chief Medical Writer
  12. MEDICA 2024

    Mantra Systems at MEDICA 2024

    Mantra Systems is going to MEDICA 2024, the largest medical trade fair in the world. We hope to see you there.

    Richard Jones Richard Jones Operations Director
  13. EU flags

    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 Shona Richardson Regulatory Medical Writer
  14. EU flag

    MDCG 2024-10 - Orphan medical devices

    How to apply MDR pre-market clinical evidence requirements to medical devices intended for limited usage.

    Dr Simon Cumiskey Dr Simon Cumiskey Senior Lead Medical Writer
  15. Considering a medical device's intended purpose

    A medical device's intended purpose - what is the point?

    How do you define intended purpose, indication for use, intended clinical benefits, and claims?

    Dr Simon Cumiskey Dr Simon Cumiskey Senior Lead Medical Writer
  16. Mantra Systems presents EnableChat, your AI-powered MDR & MDCG chatbot

    EnableChat - Your AI-powered MDR and MDCG chatbot

    Search the MDR and MDCG documents in seconds by asking EnableChat your questions.

    Dr Simon Cumiskey Dr Simon Cumiskey Senior Lead Medical Writer
  17. Searching adverse event databases for vigilance data

    Staying vigilant - A guide to searching for adverse events data

    We discuss the pros and cons of existing adverse event databases for vigilance data searching.

    Dr Simon Cumiskey Dr Simon Cumiskey Senior Lead Medical Writer
  18. A doctor reading an SSCP document with a patient

    What is Summary of Safety and Clinical Performance (SSCP)?

    We explain what the SSCP is, when you'll need it and what its objectives are.

    Sandra Gopinath Sandra Gopinath Chief Regulatory Officer
  19. A woman in a laboratory looking down a microscope

    Scientific Validity Reports – Foundation of the IVDR Performance Evaluation

    Justifying scientific validity is the first step in proving compliance with the IVDR.

    Dr Gayle Buchel Dr Gayle Buchel Chief Medical Writer
  20. MEDICA 2023

    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 Shen May Khoo Junior Regulatory Specialist
  21. A pile of question marks

    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).

    Shen May Khoo Shen May Khoo Junior Regulatory Specialist
  22. A signpost giving unsure directions

    MDR or IVDR - A sibling rivalry?

    A guide to easily understanding whether your device is a medical device or an in vitro diagnostic medical device (IVD).

    Dr Gayle Buchel Dr Gayle Buchel Chief Medical Writer
  23. An EU and UK flag

    What the latest Brexit U-turn means for CE Marking of medical devices in Great Britain

    Will Great Britain continue to allow the use of the CE mark for medical devices beyond the 2024 deadline?

    Dr Hanna Gul Dr Hanna Gul Lead Medical Writer
  24. A woman writing her own medical device regulation documentation

    Gain confidence, reassurance and control over your EU MDR strategy

    Find out how to build your own technical files within a guided framework while minimising financial outlays.

    Dr Gayle Buchel Dr Gayle Buchel Chief Medical Writer
  25. Racing to achieve MDR compliance

    Still racing to achieve MDR compliance? A transition period update

    On January 6th 2023, the EU commission has adopted the proposal to extend the transition rules of the EU MDR.

    Sandra Gopinath Sandra Gopinath Chief Regulatory Officer
  26. A 7-step guide to navigating regulatory requirements for medical device start-ups

    A medical device regulations guide for start-up companies

    We present a 7-step guide to navigating regulatory requirements on a budget.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  27. An update on UKCA Marking of Medical Devices

    UKCA Marking of Medical Devices – An update on the status quo

    We review recently updated requirements for UKCA marking and what it means for your regulatory strategy.

    Dr Hanna Gul Dr Hanna Gul Lead Medical Writer
  28. How to choose a CER writer for your MDR Clinical Evaluation

    Choosing a CER writer for your MDR Clinical Evaluations

    We've compiled a list of considerations that will help you make the right choice when choosing a CER writer.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  29. Achieving MDR Compliance for Class I medical devices

    How to achieve MDR Compliance for Class I medical devices

    We outline a strategy for the regulatory compliance of Class I medical devices.

    Sandra Gopinath Sandra Gopinath Chief Regulatory Officer
  30. Literature Search, SOTA Review and Clinical Evaluation

    Literature Search, SOTA Review process and Clinical Evaluation

    We help to demystify the process of systematic search & review of literature for Clinical Evaluation.

    Sandra Gopinath Sandra Gopinath Chief Regulatory Officer
  31. Literature Search Protocols & SOTA Reviews for medical devices and what to know before you start

    Literature searches and reviews for medical devices - what to know before you start

    We explain what you should know before beginning a literature search & review for your medical device.

    Sandra Gopinath Sandra Gopinath Chief Regulatory Officer
  32. Five useful resources when writing a medical device CER

    Five useful resources when writing a medical device CER

    We outline five of the most useful and trustworthy Clinical Evaluation Report writing resources.

    Dr Victoria Cartwright Dr Victoria Cartwright Relationship Manager
  33. Avoid pitfalls when writing a Clinical Evaluation Report

    Five common pitfalls when writing a Clinical Evaluation Report

    We illustrate five pitfalls when writing CERs and give you some tips to overcome them.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  34. How to make a medical device equivalence claim under the MDR

    Five tips for making a medical device equivalence claim under the MDR

    We'll show you what to keep in mind with regards to equivalance and Clinical Evaluation.

    Sandra Gopinath Sandra Gopinath Chief Regulatory Officer
  35. Keeping medical devices in market and maintaining CE-marks - a guide to effective data collection

    Keeping medical devices in market and maintaining CE-marks

    The 4 golden rules to drive regulatory compliance with PMCF and vigilance data collection.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  36. How PMCF goes beyond simple compliance - improving products and engaging customers

    How PMCF goes beyond simple compliance

    The wider benefits of a well-designed PMCF system include improving your products and your relationship with your clients.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  37. 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.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  38. 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.

    Richard Jones Richard Jones Operations Director
  39. 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.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  40. 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.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  41. 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.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  42. Simplifying the challenges posed by the new EU MDR

    Simplifying the challenges posed by the new EU MDR

    Our CEO Dr Paul Hercock was invited to speak on a Kaizen Life Sciences podcast about the challenges posed by the EU MDR.

    Dr Victoria Cartwright Dr Victoria Cartwright Relationship Manager
  43. Why medical doctors can drive MDR compliance

    Why medical doctors can drive MDR compliance

    Working with the MDR requires knowing how to work with clinical evidence. Medical doctors are perfectly positioned to meet this requirement.

    Dr Victoria Cartwright Dr Victoria Cartwright Relationship Manager
  44. Software as a Medical Device

    Software as a Medical Device

    Unless you have spent time working with medical device legislation in the past, the idea that software could be a medical device may be rather unexpected.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  45. clinical investigator for pmcf eu mdr compliance

    Ensuring that clinical investigations work in practice

    How can medical device manufacturers ensure valid clinical investigations when access to medical expertise remains limited?

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  46. Coronavirus and medical device regulations

    Relaxing medical device regulatory requirements during a healthcare crisis

    During the coronavirus pandemic, how far should we go when relaxing medical device regulatory requirements?

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  47. EU flag

    A proposal to delay the EU MDR gets approved

    A vote in the European Parliament has decisively approved a delay to full implementation of the EU MDR by one year.

    Richard Jones Richard Jones Operations Director
  48. EU regulators may delay MDR enforcement

    EU regulators may delay MDR enforcement. Out of the woods?

    A delay of the MDR would be welcome news for many, but what would a delay mean in practice? To what extent can preparations for EU MDR be put on ice?

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  49. The new MDR compliance challenge

    The new MDR compliance challenge

    Across the industry, medical device companies are facing challenges in meeting the demands of the new Medical Device Regulations (MDR) 2017/745 framework.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  50. Sources of Real World Evidence for MDR compliance

    Sources of Real World Evidence for MDR compliance

    At Mantra Systems our objective is to make sure that our clients choose the method of real world data harvesting that is right for them.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer

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