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
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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
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Editor-in-Chief:
- Phillip Leventhal (4Clinics, Lyon, France)
Co-Editor:
- Evguenia Alechine (Epsilon Scientific Communication, Buenos Aires, Argentina)
- Stephen Gilliver (TFS Trial Form Support, Lund, Sweden)
Managing Editor
- Victoria White (Tampa, Florida, USA) Email: MEW@emwa.org
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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)