Pacemakers, hip replacements or defibrillators are all medical devices which help keep us alive or improve the quality of our lives. But if these devices are not of high quality, these devices can disrupt, damage or destroy our lives.

Several high-profile scandals shook the medical devices industry, including the notorious PIP breast implant scandal where an estimated 300,000 women across 65 countries were given industrial industrial-grade silicone instead of the medical-grade required.

As a result, the EU began to improve its standards for medical devices. BEUC pushed for the introduction of proper pre-market assessment of medical devices in the EU, a more coherent, risk-based classification system and better market surveillance. We deemed these essential to guarantee European consumers timely access to innovative treatment without compromising their safety.
Our advocacy included powerful testimonials from consumers who had been affected by the PIP scandal.

The EU’s latest rules date from 2017 and entitle consumers to receive more and better information on medical devices. Where problems occur, consumers should receive proper follow up and proper compensation for the damage they have suffered. The rules also enhance vigilance, market surveillance and transparency of medical devices.