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Update on Notified Bodies designation under MDR / IVDR

The implementation of the new European MDR (2017/745), now in place since May 2021 and IVDR (2017/746) less than a year away, has proven to be a very challenging task...
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EUDAMED is LIVE

The Medical Devices Regulation (EU) 2017/745 and In Vitro Diagnostic Regulation (EU) 2017/746 include use, maintenance and management of a European databank on medical devices (EUDAMED). The database consists of...
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MD Regulatory transition under Brexit

With the UK having exited the EU in February 2020 (Brexit), manufacturers of medical devices and IVDs need to ensure they have plans in place to comply with the UK...
Deadline extended

MDR – Some Class I Device Transitions Extended

Under growing pressure from industry and notified bodies, the need to provide some breathing space around Medical Device Regulation (MDR) deadlines by the European Commission has finally been considered. After...
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And out they go…BREXIT is final! But what about Australia?

After several years of leadership changes, elections and conspiracies, we’ve finally arrived at the exit gate. Effectively, with no deal being reached, the implications to the UK are significant, however...
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Halfway there? Will the MDR/IVDR train arrive on time – and what about Brexit?

As the implementation journey for the EU MDR/IVDR passes the halfway point, we provide an update to the current state of play and the impact on our industry. Many, if...

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