
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...

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...

Brexit appears inevitable – and it seems UK MHRA will emulate New Zealand!
As the dust settles on the UK general election, it appears that Brexit is inevitable, it's only a matter of short term timing and terms. So what does this mean...

And so starts the MDR/Brexit fallout… First LRQA and now QS Zurich fall by the wayside
Breaking News: As of June 13th, Lloyds Register Quality Assurance (LRQA) withdrew from MDD and IVDD services (see the announcement here). It's official, the first notified body based in UK...

Fog in the Channel: a European Medtech Perspective on Brexit
An apocryphal newspaper headline reported, "Fog in the Channel - Continent Cut Off". All very whimsical and a metaphor for a peculiarly anglo-centric world view. But as the UK stumbles...

How a No Deal Brexit may Jeopardise Medical Device Supply in Australia
This is not just a political temper tantrum in a small Island somewhere off the coast of France. Brexit will have global implications: including some strange effects in markets far...