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Efforts are underway by EU notified body groups to encourage a uniform interpretation of the EU MDR when it comes to the risk classification of spinal implants. Their work could also reduce the amount of unnecessary notified body and expert panel work on some implantable devices.
Latest From Europe, Policy & Regulation
Most low-risk medical devices and IVDs do not need notified body involvement in the EU. This means that, in the event of a no-deal Brexit, they are not impacted by UK government rules that focus on notified bodies. But what will change for low-risk devices and IVDs in the UK post-March 29, the UK's scheduled EU exit day?
What do incoming EU notified bodies need to do, and what shortcuts might they be able to take, when manufacturers transfer from one notified body to another?
Three experts talk about what it takes logistically for medtech businesses to prepare for timely compliance with the new EU Medical Device and IVD Regulations, and they spell out some of the challenges companies have encountered during a panel discussion at the recent LSX World Congress in London.
One In Three Medtech Innovators Will Be 'Driven Out Of Business' By EU MDR, German Business Survey Finds
The EU Medical Device Regulation is 15 months away from being implemented in full, and a new German survey about its potential impact on the medtech innovation and patient-care landscape makes for sobering reading.
There is now even more urgency for medtech companies, including small firms, to employ the services of EU27 notified bodies – with UK notified bodies set to have their conformity assessment roles temporarily withdrawn if the UK leaves on March 29 without a deal.
It is not only the UK trading relationship with the EU that could be interrupted after post-Brexit; relationships with countries with whom it enjoys mutual recognition agreements currently via the EU are also in jeopardy. How much progress has been made? And what happens next?
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