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Medical devices: more safety, more traceability

Stricter rules to ensure that medical devices such as breast or hip implants are traceable and comply with EU patient safety requirements were backed by MEPs on 5th April 2017. MEPs also approved laws to tighten up information and ethical requirements for diagnostic medical devices, e.g. for pregnancy or DNA testing. Both proposals had been informally agreed with the Council.

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

Stronger post-market surveillance, more information to patients

“We’ve also agreed a much stronger system of post-market surveillance so that any unexpected problems are identified and dealt with as soon as possible”. “With the PIP breast implants scandal, many women simply didn’t know if they had received defective implants or not. So we’ve also introduced a Unique Device Identification system to help trace patients, who will also be given an implant card, which they can use to access information via a publicly accessible database”, Ms Willmott added.

Learning the lessons of the breast and hip implants scandals

The rules provide for:

  • random inspections of producers’ facilities after devices have been placed on the market,
  • stricter controls on notified bodies, which will have to employ medically skilled people,
  • an additional safety checking procedure for high risk devices, such as implants or HIV tests. Not only a notified body, but also a special committee of experts, will check that all requirements are met,
  • an “implant card” for patients, enabling patients and doctors to track which product has been implanted, and
  • clinical evidence of medical device safety to be provided by manufacturers (as for medicines), especially in the case of higher risk classes.

A separate law will also ensure that the new rules also apply to in-vitro diagnostic medical devices, i.e. those that are not in direct contact with the patient, but provide health information, such as HIV, DNA or blood testing devices.

Ethical requirements for DNA testing

The legislation would also require EU member states to inform patients of the consequences of DNA tests.

Read more: http://www.europarl.europa.eu/news/en/news-room/20170329IPR69055/medical-devices-more-safety-more-traceability