Medical devices: MEPs to approve stricter EU safety requirements
Plans for stricter monitoring and certification procedures to ensure full legal compliance and traceability of medical devices, such as breast or hip implants, will be put to a vote on Wednesday. MEPs will also vote on legislation to tighten up information and ethical requirements for diagnostic medical devices, used for example in pregnancy or DNA testing. Both draft laws have been informally agreed with the Council of Ministers.
Post-market surveillance will be strengthened, so that unexpected problems are identified and dealt with faster. In the PIP breast implant scandal, many women simply did not know whether they had received defective implants. The legislation will introduce a Unique Device Identification (UDI) system to ensure it is always possible to trace which patient has which device.
The agreement also provides for random inspections of producers’ facilities after devices have been placed on the market, stricter checks on “notified” (conformity assessment) bodies, which will have to employ medically skilled people, and an additional safety checking procedure for high risk devices such as implants or HIV tests.
Debate: Tuesday, 4 April
Vote: Wednesday, 5 April
Procedure: Ordinary legislative procedure, second reading agreement