A proposal to delay the EU MDR gets approved

Richard Jones
EU flag

A vote in the European Parliament has decisively approved a delay to full implementation of the EU’s MDR by one year, allowing the medical device industry to prioritise its Covid-19 response efforts.

The EU MDR implementation date was set for 26th May 2021. However in light of this coronavirus pandemic and with an urgent need for medical device manufacturers to help supply much needed equipment to resource-stretched hospitals, a proposal crafted by the European Commission received an approval — 693 votes in favour, 1 against, and 2 abstentions — to push back the implementation date.

This delay will be welcomed by some companies that were not ready for the switch-over, and it offers more time to take stock, zoom out and re-assess their regulatory strategy. We offered 5 tips to make best use of more time that might help in such a re-evaluation.

Related articles

  1. A poster frame for our Clinical Evaluation video series featuring Paul Hercock.

    Guide to Clinical Evaluation: Common Pitfalls & Useful Resources

    Part 5 - In the final video from this series, we explore five major pitfalls that often derail clinical evaluations.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  2. Webinar announcement poster.

    Webinar: Regulatory & Cybersecurity Essentials for medical device software and AI-enabled devices

    Our webinar with Cyber Alchemy addressed bringing AI-enabled medical devices to market with both the right regulatory and cybersecurity foundations.

    Shen May Khoo Shen May Khoo Regulatory Project Lead
  3. MEDICA logo.

    Mantra Systems at MEDICA 2025

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

    Megan Allen Megan Allen Regulatory Medical Writer
  4. A poster frame for our Clinical Evaluation video series featuring Dr. W. Brambley.

    Guide to Clinical Evaluation: CEP Strategy & CER Structure

    Part 4 - We explore how these guide reviewers through the evidence that supports safey, performance, and conformity.

    Dr Will Brambley Dr Will Brambley Lead Medical Writer
  5. A view of the stage at the AI Health Summit.

    Redefining Care Through AI: Perspectives from the AI in Health Summit 2025

    Conversations around AI in healthcare have evolved dramatically over the past few years. We found insight, debate and a healthy dose of cautious optimism at this summit.

    Kamiya Crabtree Kamiya Crabtree Regulatory Medical Writer
  6. A poster frame for our Clinical Evaluation video series featuring Dr. W. Brambley.

    Guide to Clinical Evaluation: The State-of-the-Art (SOTA) Literature Review

    Part 3 - This is core of a sucessful submission. Will demystifies the process and explains how it supports clinical evaluation.

    Dr Will Brambley Dr Will Brambley Lead Medical Writer
  7. A poster frame for our Clinical Evaluation video series featuring Dr. P. Boxall.

    Guide to Clinical Evaluation: Clinical Evaluation in Context

    Part 2 - A clinical evaluation demonstrates that a device is safe and effective, but achieving this requires more than simply compiling studies.

    Dr Peter Boxall Dr Peter Boxall Lead Medical Writer

More articles

Do you need support with your medical device approval strategy?

Contact us today