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Set Alert for Policy and Regulation - Europe

Spinal Implants: Finding A Manageable Regulatory Pathway Through Complex EU MDR Wording

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.

Medical Device Europe Policy & Regulation

Latest From Europe, Policy & Regulation

How Are Low-Risk Devices And IVDs Impacted By A No-Deal Brexit – In The UK And EU27?

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?

Medical Device Europe

EU Offers Efficiency Tips For When Manufacturers Transfer Notified Bodies

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?

Medical Device Europe

The Cost And Complexity Of Implementing The EU Medical Device And IVD Regulations

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.

Medical Device Europe

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.

Germany EU

Surprise As UK Notified Bodies Lose Major Part Of Their UK Role In Devices From March 29

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the services of EU27 notified bodies  with UK notified bodies set to have their conformity assessment roles temporarily withdrawn if the UK leaves on March 29 without a deal.

Medical Device Europe

To What Extent Are UK Medtech’s Ties With Rest Of World In Jeopardy Beginning March 29?

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?

Medical Device Europe
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