MDR

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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...
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...
TrainXstation

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...
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...

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