In a unanimous decision on Wednesday (4/22), the European Union has decided to push back the amendment to the EU MDR by one year amidst the COVID-19 pandemic. This extra time will allow more time to ensure the functionality and design of the new system, while also allowing medical device companies to work to support hospitals and health care facilities in response to the pandemic. MedTech Europe, a medical device group, released a statement in response to the decision, “The amendment will allow the medical device industry to maintain maximum focus on helping healthcare systems to combat COVID-19, and on addressing the pandemic’s impact on the whole healthcare ecosystem.”
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