Medical Writing Medical Devices 2017 Regulatory Matters

Volume 26, Issue 2 - Medical Devices 2017

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.
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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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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

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Editoral Board

Editor-in-Chief

Raquel Billiones

Co-Editors

Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Associate Editors

Anuradha Alahari

Jennifer Bell

Nicole Bezuidenhout

Claire Chang

Barbara Grossman

Sarah Milner

John Plant

Sampoorna Rappaz

Amy Whereat

Section Editors

Daniela Kamir

AI/Automation

Jennifer Bell

Biotechnology

Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News 

Ana Sofia Correia 

Gained in Translation

Ivana Turek

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh 

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Maddy Dyer

Publications

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Payal Bhatia

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Adriana Rocha

Freelancing

Tiziana von Bruchhausen

Pharmacovigilance

Clare ChangZuo Yen Lee 

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Louisa Ludwig-Begall / Sarah Kabani

The Crofter: Sustainable Communications

Louisa Marcombes

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

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Chris Monk