About Careers Internship MedBlogs Contact us
Medindia LOGIN REGISTER
Advertisement

EU Improves Safety of Medical Devices After PIP Breast Implant Scandal

by Thilaka Ravi on September 25, 2013 at 8:03 AM
Font : A-A+

EU Improves Safety of Medical Devices After PIP Breast Implant Scandal

The EU's executive on Tuesday moved to improve the safety of medical devices following the worldwide scare over faulty PIP breast implants from France.

The European Commission issued new rules for the 80-odd "notified bodies" in the European Union that are responsible for the inspection of 10,000 medical devices -- from plasters to pacemakers.

Advertisement

"We now have a clearer basis for unannounced audits, sample testing, or joint assessments by notified bodies," said the Commissioner for Consumer Policy, Neven Mimica.

The new rules state that a member state can only designate a notified body after a "joint assessment" involving experts from the Commission and other nations. Authorities also will be required to regularly monitor notified bodies.
Advertisement

The inspection bodies for their part will have to randomly carry out unannounced factory audits and check for the substitution or adulteration of raw-materials.

A total of 16,426 women have had breast implants removed since it was found in 2011 that France's Poly Implant Prothese (PIP) were twice as likely to rupture as rival brands, and that the manufacturer used industrial silicone to fill them.

PIP founder Jean-Claude Mas, 73, has been charged with manslaughter and fraud. PIP's implants have been banned and the company, located in southern France, has been liquidated.

Source: AFP
Advertisement

Advertisement
News A-Z
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
What's New on Medindia
Monkeypox Outbreak: What it is, How Does it Spread & the Prevention
Seasonal Allergy Medications
How to Choose the Best Eczema-Friendly Moisturizer for Children?
View all
Recommended Reading
News Archive
Date
Category
Advertisement
News Category

Medindia Newsletters Subscribe to our Free Newsletters!
Terms & Conditions and Privacy Policy.

More News on:
Mastitis Breast Augmentation Breasts - Structures and Types Breast Lumps Breast Lumps-Screening Breast Enhancement Oil 

Most Popular on Medindia

Blood Donation - Recipients Drug - Food Interactions Vent Forte (Theophylline) Turmeric Powder - Health Benefits, Uses & Side Effects How to Reduce School Bag Weight - Simple Tips Diaphragmatic Hernia Sanatogen Accident and Trauma Care Daily Calorie Requirements Drug Interaction Checker

Disclaimer - All information and content on this site are for information and educational purposes only. The information should not be used for either diagnosis or treatment or both for any health related problem or disease. Always seek the advice of a qualified physician for medical diagnosis and treatment. Full Disclaimer

© All Rights Reserved 1997 - 2022

This site uses cookies to deliver our services. By using our site, you acknowledge that you have read and understand our Cookie Policy, Privacy Policy, and our Terms of Use