Meeting on Wednesday 16 June, MEPs on the Committee backed plans for stricter monitoring and certification procedures to ensure full compliance and traceability of medical devices such as hip or breast implants.
MEPs also approved legislation to improve information and ethical requirements for diagnostic medical devices, such as those used in pregnancy or DNA testing.
Speaking about the decision to back stricter controls the rapporteur on medical devices, Glenis Willmott, said:
“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, will be subject to additional assessments by experts before they can be authorised.”
The metal on metal hip implant crisis is thought to have affected hundreds of people in the UK who have been left with serious health problems after being fitted with metal on metal hip replacements.
The Committee has also agreed that a stronger post-market surveillance system is needed so that any unexpected problems with devices are identified as quickly as possible and acted upon.
The Committee has introduced a Unique Device Identification (UDI) system so that consumers will know which patients have been implanted with which device. This will make it much easier to trace patients if a problem is identified with a particular device. Patients will be given an implant card with the UDI which will be linked to a publicly available database.
The agreement of the Committee provides 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.
The Committee has also approved a law which will ensure that the new rules will apply to in vitro diagnostic medical devices, such as blood test devices. The legislation will also require EU member states to tell patients of the consequences of DNA tests.
The reports from the Committee have been approved unanimously and will be put to a vote by the full Parliament early in 2017.
Medical device lawyer Jill Paterson said:
“I am pleased to see that MEPs have been looking closely at this issue, which affects thousands of patients across the EU implanted with medical devices.
“I hope that the European Parliament adopts the recommendations from the Health Committee when they are presented to it next year.”