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Latest From Brexit
The UK is the middle of a week of Brexit votes in Parliament, but confusion for medtechs and the wider industrial community has not been quelled at all, regardless of two days of voting already, and a third to come today.
MedTech Europe is calling for European-wide action on continued availability of medical devices in the immediate aftermath of Brexit as countries divide, and statistics demonstrate potentially major health threats ahead.
While the UK says it will continue to recognize EU27-issued certificates for medical devices in the event of a no-deal Brexit, the EU has not offered to reciprocate. European imaging, health IT and electromedical manufacturers are now pressuring the European Commission to set up limited transition arrangements.
The Therapeutic Goods Administration has released a statement on the implications of Brexit for medical devices in Australia.
With less than four weeks to go until the UK is due to leave the EU, seven of Medtech Insight's top 10 EU regulatory stories in February focused on what will happen if the UK leaves without a deal – a possibility that has been looking increasingly likely.
Will your company be impacted by the UK MHRA’s new registration scheme in the event of a no-deal Brexit? And if so, how? What will it cost you, and how frequently will you have to pay?
The UK government is introducing new registration requirements for medical devices in the event of a no-deal Brexit. They will be rolled out according to the risk class of products. But some fundamental questions have arisen.
European Commission issues Q&A document to help industry understand specifics of “placing” products on the EU market in the context of Brexit, and what needs to be done regarding responsible persons, importers and certificate transfers.
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?
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