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EU MDR Panel Discussion: Why An Extra Year Is Not Really A Delay For The MDR – How To Survive Changing And Confusing Times

 
• By Amanda Maxwell

26 May 2020, the date that the Medical Device Regulation was originally due to apply in the EU, was a good time to take stock of where the medtech sector finds itself. Three of the most renowned and outspoken experts on the EU medical device regulatory system gave their views in this exclusive interview.

Exclusive interview Q&A KOI

The one-year delay in the application of the EU Medical Devices Regulation (MDR), until 26 May 2021, does not offer as many flexibilities as it seemed to promise, and neither does it span a whole year. Some who play an important role in the sector still seem unaware that a postponement has even been formally agreed.

With so many recent changes and a backdrop of uncertainty, confusion and shifting requirements, Bassil Akra of TÜV-SÜD notified body,...

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• By Natasha Barrow

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• By Brian Bossetta

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More from Geography

With LDT Rule DOA, Could FDA Shift Focus To RUOs?

 
• By Brian Bossetta

Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?

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• By Derrick Gingery and Sue Sutter

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A Year After Exiting The Ventilator Market, Medtronic Recalls Thousands Of Newport Devices

 
• By Brian Bossetta

After two serious injuries and one death linked to some of its ventilators, Medtronic has recalled the devices and asked customers to stop using them and find alternative means. The action comes more than a year after the company left the market.