- Published: Wednesday April 5 2017 16: 53
Medical devices such as prostheses and HIV tests will be subject to stricter controls in the EU under a new EU law, adopted in the wake of scandals such as the 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, negotiated for nearly five years, provides for stricter controls of certification bodies will be required to employ qualified people in the medical field, random inspections of manufacturers after the devices were placed on the market, and the establishment of an "implant map" for patients to strengthen product traceability.
The measures concerning medical devices should be in place no later than 2020, those affecting diagnostic devices later than 2022.
"These texts are putting an end to an era where an implantable medical device almost met the same regulatory obligations than a toaster!", Welcomed French MEP Françoise Grossetête (EPP, right).
In the case of breast implants made by French company PIP, the certifier TÜV was sentenced in January to pay 60 20.000 million to complainants victims of these implants, filled with a gel fraud in violation of health rules .
The Commercial Court of Toulon (south of France) ruled that the certifier had not carried out the necessary checks.