Medical devices such as prostheses and HIV tests will be subject to stricter controls in the EU under new EU legislation, adopted following scandals such as PIP breast prostheses.
The European Parliament on Wednesday approved on second reading two draft laws on medical devices such as breast implants and hip replacements, and on medical devices for in vitro diagnosis such as pregnancy tests.
The new legislation, which has been negotiated for almost five years, provides for stricter controls by certification bodies who will be required to employ qualified persons in the medical field, random inspections of manufacturers after devices have been placed on the market, and the establishment of an "implant card" for patients, in order to reinforce the traceability of products.
The measures concerning medical devices should be in place no later than 2020, those affecting diagnostic devices later than 2022.
"These texts bring an end to an era where an implantable medical device met almost the same regulatory requirements as a simple toaster! "Welcomed French MEP Françoise Grossetête (EPP, right).
In the case of breast prostheses manufactured by the French company PIP, the certifier TÜV was sentenced in January to pay 60 million euros to 20.000 plaintiffs victims of these prostheses, filled with a fraudulent freeze in violation of health rules .
The Commercial Court of Toulon (South of France) had judged that the certifier had not carried out the necessary checks.