Dutch regulators explain no-deal Brexit impact for medical device companies

By Ronald Boumans, Emergo Group

The United Kingdom (UK) may leave the European Union (EU) on 29 March 2019. The draft agreement on Brexit has not yet been ratified by the UK and the EU parliaments. The Netherlands and the EU are therefore still preparing for various scenarios. One of those scenarios is that no agreement is reached (a ‘no deal’ scenario). In case of a no deal Brexit, existing legislation concerning medical devices and in-vitro diagnostics will no longer be applicable to the UK as of the withdrawal date at which the UK leaves the EU. The EU legislation does not change, but companies that are based in the UK or that distribute their devices via the UK to the EU must adapt to the new situation in which the UK will become a third, non-EU country.

Get the full story here at the Emergo Group’s blog.

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