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Deadline extended

Some Class I Device Transitions Extended – MDR

By Grant Bennett | 3 February, 2020
Under growing pressure from industry and notified bodies, the need to provide some breathing space around MDR deadlines by the European Commission has finally been considered. After much focus on...
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And out they go…BREXIT is final! But what about Australia?

By Grant Bennett | 30 January, 2020
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...
TrainXstation

Halfway there? Will the MDR/IVDR train arrive on time – and what about Brexit?

By Luis Jimenez | 3 December, 2018
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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Recent Posts

Some Class I Device Transitions Extended – MDR

Feb 3, 2020

And out they go…BREXIT is final! But what about Australia?

Jan 30, 2020

TGA acceptance of international device reviews – clearing the fog

Dec 20, 2019

Brexit appears inevitable – and it seems UK MHRA will emulate New Zealand!

Dec 19, 2019

A single review program for medical devices?

Dec 2, 2019

The door to Europe is closed – so where else should I look?

Dec 2, 2019

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