EU Advances Stricter Device Safety Requirements

June 17, 2016

Stricter requirements on safety evidence, monitoring and certification for medical devices have won support from members of the EU Parliament’s Health Committee.

The measures are intended to improve compliance and traceability in light of issues with breast and hip implants.

“The metal-on-metal hip scandal highlighted weaknesses in the current system,” said Glenis Willmott, rapporteur on medical devices. “So we’ve introduced much stricter requirements for the bodies that authorize medical devices, and will insist that particularly high risk devices, such as implants, joint replacements or insulin pumps, will be subject to additional assessments by experts before they can be authorized.”

Under the measure, devicemakers would need to provide clinical evidence of device safety, especially for higher-risk devices. They can also expect random facility inspections after devices are on the market, as well as an additional safety-check for high-risk devices. In addition to a notified body, a special committee of experts would confirm that all requirements are met.

There would also be stricter controls on notified bodies, which would have to include medically skilled members.

Additionally, the measure would require stronger postmarket surveillance. For example, patients would receive an “implant card” so they and their physicians can track which product has been implanted.

“With the [breast implant] scandal, many women simply didn’t know if they had received defective implants or not. So we’ve also introduced a Unique Device Identification (UDI) system so we know which patient has which device; this will make it much easier to trace patients if there’s a problem and patients will also be given an implant card with the UDI, which they can use to access information via a publicly accessible database,” Wilmott added.

In addition to the device measures, the Health Committee MEPs approved stricter data and ethics requirements for diagnostics. These would affect diagnostics used for pregnancy testing, DNA testing and other areas. The legislation would also require EU member states to inform patients of potential consequences with DNA tests.

Both reports will be up for a full House vote early next year. — April Hollis