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’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. 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
  2. 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
  3. 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
  4. 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
  5. 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

More articles

Do you need help with your MDR strategy?

Talk with us

Hello there…