Briefing 
 

Medical devices: better controls and traceability to ensure patients’ safety 

Parliament votes on Wednesday on plans to strengthen monitoring and certification procedures for medical devices such as breast or hip implants to ensure that they comply fully with safety standards and can be traced. Separate rules tightening up information and ethical requirements for diagnostic medical devices used for example in pregnancy or DNA testing will also be put to the vote.

The proposed rules aim to give patients and medical staff clearer and fuller information and to increase traceability. In the wake of recent scandals in which the number of patients with potentially defective implants remained unknown, MEPs want patients to receive an "implant card" and to be registered so that they can be alerted if any incidents are reported with a similar product. Their amendments also aim to beef up the so-called “notified bodies” in charge of assessing the safety of the devices.


Vote: Wednesday, 2 April

Procedure: Co-decision (Ordinary Legislative Procedure), first reading

Press conference Wednesday (tbc)

#medicaldevices #IVD #PIP #metalonmetal