Medical Writing Medical Devices Regulatory Matters
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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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Articles

Medical Devices: An exciting industry at a crossroads
President's Message
EMWA News
Writing for medical devices compared to pharmaceuticals: An introduction
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New EU medical device regulations: Impact on the MedTech sector
Medical Device Regulation: A necessary step towards more patient and user safety
Transparency – left to its own devices until now
Medical devices in the disclosure era and the role of medical writers
Does standardisation improve animal testing of medical devices?
Puns, promises, and metaphors: Medical device trade names
French breast implants, the Medical Device Regulation, and a theoretical case study
Science journalism: In search of a new identity
Can a medical writer submit a manuscript on behalf of a corresponding author?
To be or not to be – Are medical and scientific writers of non-native English origin at a disadvantage?
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

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Editoral Board

Editor-in-Chief:

Co-Editor:

Managing Editor

  • Victoria White (Tampa, Florida, USA)
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Associate Editors:

Section Editors:

Ad-hoc Editors:

  • Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)

Editor Emeritus: