COVID-19 Causes EU MDR Delays (New CE Mark Reg
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Posted On: 05/22/2020 10:21:15 AM
Re: graveldrive #2442
COVID-19 Causes EU MDR Delays
(New CE Mark Regulations pushed out 1 year to 5/26/2021)
Why is the EU announcing an MDR delay?
The timing of COVID-19 created particularly heavy lifting for the medical device industry. In the midst of the pandemic, the sector was scheduled for major regulatory change.
Now, industry players must balance securing the availability of medical equipment during the COVID-19 crisis, ensuring supply of other important medical devices for patients with critical or chronic conditions, and meeting the new stricter EU MDR requirements that aim to address weaknesses and safety gaps in the current EU system.
All three needs carry their own ethical weight and bearing on the well-being and safety of patients. This is exactly what makes the current situation an unprecedented burden for industry and regulators. In order to help industry and authorities prioritise COVID-19, the European Commission therefore made the tough but necessary call to adopt the proposal from the European Commission to postpone MDR.
https://www.lionbridge.com/blog/the-disruptio...dr-delays/
(New CE Mark Regulations pushed out 1 year to 5/26/2021)
Why is the EU announcing an MDR delay?
The timing of COVID-19 created particularly heavy lifting for the medical device industry. In the midst of the pandemic, the sector was scheduled for major regulatory change.
Now, industry players must balance securing the availability of medical equipment during the COVID-19 crisis, ensuring supply of other important medical devices for patients with critical or chronic conditions, and meeting the new stricter EU MDR requirements that aim to address weaknesses and safety gaps in the current EU system.
All three needs carry their own ethical weight and bearing on the well-being and safety of patients. This is exactly what makes the current situation an unprecedented burden for industry and regulators. In order to help industry and authorities prioritise COVID-19, the European Commission therefore made the tough but necessary call to adopt the proposal from the European Commission to postpone MDR.
https://www.lionbridge.com/blog/the-disruptio...dr-delays/
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