Arthur Brandwood

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NZ Makes it Formal – Medical Devices Reform in The Land of the Long White Cloud

New Zealand has always been a relaxed sort of place – and that included the regulation of medical devices which up till now has been limited to a simple notification...
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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...
Reform

Regulatory Change in Australia – TGA’s wish list for 2019

TGA works hard to keep up to date in this rapidly changing world and that’s certainly the case this coming year. An indication of reforms to come can be gained...
Australiabrexit

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...
Brexit

Brexit – BSi confirms UK issued CE to become invalid

Brexit - this is where the wheels come off: UK (and now Dutch) Notified Body BSi has advised that all UK issued CE certificates become invalid in case of no...
Gandalf

New Zealand WANDers towards increased device regulation

If you are WANDering about the title of this blog, yes, it’s a dreadful pun I know – but it’s that time of year. New Zealand’s Medsafe have issued a...
HarmonisationXarticleXimage

Harmonization in Plain Sight. Are FDA and CE Substantially Equivalent?

Medical device harmonization continues to struggle, with substantial differences between FDA and Europe continuing to be an obstacle. However, current changes in Europe and proposed changes in the US may...
apple-watch-3-2

Not so fast. What really happened with FDA’s clearance of the Apple Watch ECG

There’s lots of noise about the very rapid de novo clearances for Apple’s “Irregular Rhythm Notification Feature” (DEN 180042) and ECG App (DEN180044) for the Apple Watch. FDA cleared both...
FDA

FDA raises fees 4%

The new US financial year as always heralds increases in regulatory fees.  FDA published its 2019 fees at end of July. Fees are up around 4% across the board. The...
Uncertainty

Risk vs. Benefit FDA guidance gets to grips with uncertainty

Doing risk management in an uncertain world is why regulatory affairs are as much art as science. Innovators will continue to push the envelope of the possible while regulators will...

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