In the latest issue of MPN, our editor Laura Hughes provides an update on the European Medical Device Regulation (EU MDR).
Is the EU MDR still set to take effect on May 26th, 2020?
No. To allow manufacturers and medtech companies time to focus on tackling the Covid-19 pandemic, the implementation date of this regulation has been delayed.
When will EU MDR come into effect?
The date has been postponed by one year and will now come into effect on 26th May 2021.
When was this delay officially decided?
Organisations such as MedTech Europe were calling on the European Commission to consider the delay due to multiple reasons, but mainly the pandemic. The European Commission voted on delaying EU MDR and it received an outstanding 693-0 to adopt the amendment. Following this vote the delay was made official, with the publication of an amendment in the Official Journal of the European Union on 24th April, 2020.
What does this mean for manufacturers?
It will allow manufacturers to prioritise supplying safe and well-performing devices to patients, healthcare professionals, and healthcare systems on the frontline during the Covid-19 pandemic. There will also be additional time for more notified bodies to become designated and operational under the MDR.
Is the In Vitro Diagnostic Regulation (IVDR) delayed as well?
No. Currently, the IVDR is still set to take effect on 26th May 2022. A decision MedTech Europe believes “needs to be adapted by at least 12 months, both to address today’s reality and to prevent unintended fall out in the future.”