Medical Writing Medical Devices Regulatory Matters
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Volume 26, Issue 2 - Medical Devices

Regulatory Matters

Authors: Gregory Morley, Raquel Billiones

Abstract

Brexit and the European Medicines Agency

The British government has formally triggered Article 50, setting in motion Brexit and negotiations can begin in earnest. If before, politicians could gloss over the complexities, they are now obliged to start getting to grips with the details (where the devil often is if the popular saying is to be believed). With such a complex process, some unintended consequences will inevitably start to become apparent. One example is the future of the European Medicines Agency, currently located in Canary Wharf in London. During the referendum campaign, I don´t recall any talk about what fate might befall this prestigious agency. Obviously, with the UK leaving the European Union, it seems untenable to keep the EMA headquarters in London, regardless of how “soft” Brexit finally turns out to be. In fact this seems one of the few aspects of Brexit where there is some agreement.

References

  1. Medical Device Regulation (EU) 2017/… of the European Parliament and of the Council of Europe on medical devices (draft). Available from: http://data.consilium.europa.eu/doc/document/ST-10729-2016-INIT/en/pdf
  2. MEDDEV 2.7/1 revision 4 June 2016. Clinical Evaluation: A Guide for Manufacturers and Notified Bodies.

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