Healthcare Technology Featured Article

September 28, 2012

In Light of Scandals, European Commission Strengthening Implantable Device Regulations


The European Commission has chosen to tighten two regulations covering implantable devices, one to include all medical devices, the other to cover in vitro diagnostic medical devices (IVDs), according to sources.

Active implantable medical devices (AIMD) and medical devices (MDD) are the other two categories that will covered by the new stricter rules, while the second regulation covers only IVDs.

The new rules were proposed to bring legislation in line with the pace of technological and scientific progress over the last 20 years, and “uniformity as current directives lead to different interpretation and implementation in the various EU member states and consequently to different levels of patient and public health protection in the EU,” a statement read.

The new regulations’ goal is to improve traceability and transparency.

The plans will affect a huge range of products, from contact lenses to pacemakers to pregnancy testing kits to high-tech medical equipment such as life support machines.

But perhaps the most important reason these regulations are being revised is the scandal about fraudulent silicone breast implants and the problems occurring with certain metal-on-metal hip joint replacements, “which have brought the topic of medical device regulation to the attention of the public at large,” the statement continued.

Hundreds of thousands of women around the world were implanted with substandard silicone products made by defunct French company Poly Implant Prothese (PIP), which safety regulators had failed to stop for more than a decade, Reuters reported.

"In the U.S., everything is looked at by FDA, whereas in Europe, the European authorities are making the rules, but the game is played in the local countries," Viktor Joergens, MD, executive director of the EASD, told MedPage Today. More than 80 regulatory bodies in the various European countries currently oversee device regulation, according to a press release from the European Commission.

The proposal will now be reviewed by the EU parliament and the Council of EU ministers.




Edited by Rachel Ramsey
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