The European Commission (EC) has proposed new medical device regulations in response the the PIP breast implant scandal.
The proposals include a regulation on medical devices to replace directive 90/385/EEC for active implantable medical devices, directive 93/42/EEC for medical devices, as well as directive 98/79/EC for in-vitro diagnostic medical devices.
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The EC said to reap the benefits of safer medical devices, European national authorities should provide more powers and obligations to assessment bodies to ensure thorough testing and regular checks on manufacturers, including unannounced factory inspections and sample testing.
A unique device identification system will be introduced to enhance post-market safety of medical devices, to help to reduce medical errors and to combat counterfeiting, according to the EC.
The EU legislation should also extend the database on medical devices so that patients, healthcare professionals and the public can make better-informed decisions on their use.
Health and Consumer Policy commissioner John Dalli said just a few months ago, fraudulent breast implants affected tens of thousands of women in Europe and around the world.
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By GlobalData"As policy makers, we must do our best never to let this happen again," Dalli said.
"This damaged the confidence of patients, consumers and healthcare professionals in the safety of the devices on which they rely every day.
"The proposals adopted today significantly tighten the controls so as to ensure that only safe devices are placed on the European Union’s market at the same time, they foster innovation and contribute to maintaining the competitiveness of the medical device sector."
Image: The Berlaymont, Commission headquarters in Brussels. Photo: Courtesy of JLogan.
