Medical Writing
Medical Devices
French breast implants, the Medical Device Regulation, and a theoretical case study
Volume 26, Issue 2 - Medical Devices
French breast implants, the Medical Device Regulation, and a theoretical case study
Author: Claudia Frumento
Abstract
Abstract
The 2010-2011 Poly Implant Prothèse scandal triggered a review of the Medical Device Directive. This resulted in a new Medical Device Regulation that was approved this year. It contains many changes, and many questions will arise when medical device companies start certifying their medical devices per the new regulation. The solution to many unclear cases will depend on how the new regulation is interpreted. Medical writers can play a key role by creating precedents that are coherent, well documented, and useful for all stakeholders
The 2010-2011 Poly Implant Prothèse scandal triggered a review of the Medical Device Directive. This resulted in a new Medical Device Regulation that was approved this year. It contains many changes, and many questions will arise when medical device companies start certifying their medical devices per the new regulation. The solution to many unclear cases will depend on how the new regulation is interpreted. Medical writers can play a key role by creating precedents that are coherent, well documented, and useful for all stakeholders
Download the full article
References
- Poly Implant Prothèse (PIP) silicone breast implants Review of the actions of the Medicines and Healthcare products Regulatory Agency (MHRA) and Department of Health. May 2012 Available from: https://www.gov.uk/government/uploads/ system/uploads/attachment_data/file/216 537/dh_134043.pdf
- Q&A: PIP breast implants health scare. December 2013 http://www.bbc.com/ news/health-16391522. Available from: http://
- Proposal for a Regulation of the European Parliament and of the CounciL on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 Available from: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52012PC0542
Visit the EMWA website
Search
Articles
Medical Devices: An exciting industry at a crossroads
President's Message
EMWA News
Writing for medical devices compared to pharmaceuticals: An introduction
Clinical Evaluation Reports from the medical writer’s perspective!
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
Member Login
Links
Editoral Board
Editor-in-Chief:
- Phillip Leventhal (4Clinics, Lyon, France)
Co-Editor:
- Evguenia Alechine
- Stephen Gilliver (TFS Trial Form Support, Lund, Sweden)
Managing Editor
- Victoria White (Tampa, Florida, USA) Email: MEW@emwa.org
show all +
Associate Editors:
- Anuradha Alahari (PAREXEL International, Paris, France)
- Raquel Billiones (Clinipace, Zurich, Switzerland)
- Barbara Grossman (Hawkeye Medical Limited, Berkshire, UK)
- Joselita T Salita (Freelance, Bremen, Germany)
- Nathan Susnik (Hanover Medical School, Hanover, Germany)
- Clare (Chi-Chih) Chang
- Jonathan Pitt
Section Editors:
- Alison McIntosh (ICON Clinical Research, Hampshire, UK)
- Wendy Kingdom (Wendy Kingdom Ltd., Dulverton, UK)
- Lisa Chamberlain-James (Trilogy Writing and Consulting, Norfolk, UK)
- Maria Koltowska-Haggstrom (Proper Medical Writing Warsaw, Poland)
- Laura Collada Ali (Teksema, Cogne, Italy)
- Hervé Maisonneuve (Freelance, Lyon, France)
- Satyen Shenoy (Describe Scientific Writing & Communications, Cologne, Germany)
- Claire Gudex (Klinisk Institut, Odense, Denmark)
- Beatrix Doerr
- Sam Hamilton (Newcastle Upon Tyne, UK)
Ad-hoc Editors:
- Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)
Editor Emeritus:
- Elise Langdon-Neuner (Medical University of Vienna, Austria)