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UK Reveals How To Access Fast-Track Approval Of Devices During COVID-19 Outbreak

 
• By Amanda Maxwell

How to quickly get non-CE-marked medical device onto the UK market.

Fast_Track

The UK medtech regulator is expecting to receive a high volume of applications from manufacturers of products intended to address the COVID-19 crisis but which haven’t demonstrated compliance with its Medical Device Regulations 2002. The UK Medical Device Regulations 2002 transpose the EU’s Medical Devices Directive (MDD).

“We will prioritise applications based on the needs of the healthcare providers to increase the supply of critical devices and...

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More from Geography

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FDA Changes Fail To Diminish US Appeal To European Medtech Industry

 
• By Amanda Maxwell

Despite staffing cuts and uncertainty at the FDA, the US still offers EU medtech firms stronger regulatory support, regulatory expert Bassil Akra told Medtech Insight. This is especially valued as EU rules are often viewed as overly stringent, unclear and difficult to follow.