UK Notified Body BSI Sets Out Clear Post-Brexit Paths As It Goes Dutch
BSI tackles Brexit issues head-on with aim to allay fears and bring clarity while UK regulator, MHRA, remains reticent to do so. Its messages are relevant for all doing business in the UK
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During the week of the ostensibly pivotal EU Summit on Brexit, the UK government has made the EU27 wait for its white paper on proposed post-EU trading arrangements. The UK medtech industry, in turn, is kept waiting on its EU future. But far from remaining idle, manufacturers are focusing on innovation adoption and working with the NHS, where there is a new sense of purpose, and maybe a light at the end of the tunnel.
The latest round of EU Brexit negotiations were bruising encounters for the UK, whose perceived selective approach to EU membership was rebuffed again. The talks coincided with the restatement of the government's position on device- and pharma-related Brexit issues. UK medtechs may well be looking at the June EU Council meeting as the point of no return.
The hope is now that a new EU document will be issued to address head on the scale of bottlenecks at notified bodies and of products needing to be removed from the market.