Medical Writing Medical Devices Regulatory Matters

Volume 26, Issue 2 - Medical Devices

Regulatory Matters

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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Winners of the Geoff Hall Scholarship Essay Competition
Good medical writing saves lives: The perspective of a former medic
Good medical writing saves lives – and even a little comma can make a difference
Abstracts from 44th EMWA conference Poster session
News from the EMA
Journal Watch
Gained in Translation
Getting Your Foot in the Door
In the Bookstores
Regulatory Matters
The Webscout
Good Writing Practice
Profile
Out on Our Own

Member Login

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Editoral Board

Editor-in-Chief

Raquel Billiones

Co-Editors

Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Deputy Managing Editor

Alicia Waltman

Associate Editors

Anuradha Alahari

Jennifer Bell

Clare Chang

Barbara Grossman

Daniela Nakagawa

Joselita T. Salita

Petal Smart

Amy Whereat

Section Editors

Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News       

Aurélie Gobet / Paolo Rega

Gained in Translation

Ivana Turek

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh / Stephen Gilliver

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Phil Leventhal

Manuscript Writing

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Namrata Upadhyay

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Laura Kehoe

Out on Our Own

Tiziana von Bruchhausen

Pharmacovigilance

Jennifer Morris

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Kimi Uegaki

The Crofter: Sustainable Communications

Jennifer Bell / Louisa Marcombes

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Lay out Designer

Chris Monk