Simplifying the challenges posed by the new EU MDR

Dr Victoria Cartwright
Simplifying the challenges posed by the new EU MDR

Our CEO Dr Paul Hercock recently had the pleasure of working with the fantastic Kaizen Life Sciences to produce a unique podcast on the challenges posed by the new EU MDR.

The new Medical Device Regulation (EU) 2017/745 comes into force in May 2021 and replaces the existing Medical Device Directive (MDD). The MDR is 100 pages longer and has a much broader scope than the MDD, providing many challenges in achieving compliance. Companies with existing or new products must fully comply with the MDR however, for many, understanding the MDR in detail is quite a headache!

In this podcast hosted by Kaizen Life Sciences as part of their “Life Sciences Leaders” podcast series, Paul (Mantra Systems CEO) discusses the MDR and how companies in the life sciences sector can break down the MDR into more manageable action steps.

Kaizen Life Sciences are recruitment specialists in Pharma, Medical Devices, Clinical and Healthcare. For further information you can find Kaizen Life Sciences on LinkedIn or contact us for an introduction.

Related articles

  1. 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
  2. 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 Lead Medical Writer
  3. 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 Senior Regulatory Specialist
  4. 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
  5. 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
  6. 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
  7. 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 Senior Regulatory Specialist
  8. 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 Senior Regulatory Specialist
  9. 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
  10. 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 Systems Manager
  11. 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
  12. 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
  13. 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

More articles

Do you need help with your regulatory strategy?

Talk to us