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
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References

  1. 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
  2. Q&A: PIP breast implants health scare. December 2013 http://www.bbc.com/ news/health-16391522. Available from: http://
  3. 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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