Market surveillance of invasive and implantable devices will be stepped up in the European Union following a deal struck in Brussels May 26.
European Parliament and EU Council of Ministers representatives clinched a compromise deal on a proposed revision of the EU medical devices and in vitro diagnostics directives, which would limit use of substances that are carcinogenic, mutagenic, toxic for reproduction or have endocrine (hormone) disrupting properties.
The agreement, which the parliament and council still have to clear formally, bars invasive or implantable devices that come into direct contact with the human body containing these substances in proportions exceeding 0.1 percent by weight, unless their use can be justified, for example by low patient exposure. Also, under the law, when these substances are used they would have to be labelled.
Following the 2011 breast implant scandal, in which French company PIP (Poly Implant Prothèse) was found to have used industrial grade silicone, the deal also tightens up post market surveillance and traceability so that devices can be traced to each patient in case of problems.
Manufacturers would also have to follow-up on the quality, performance and safety of devices they placed on the market so that faults are spotted quickly and remedial action is rapid. The legislation would also ensure a new central database will list all devices on the market, manufacturers and the EU accredited test houses, which are called ‘notified bodies,' in EU jargon.
Also new, high risk devices face additional pre-market scrutiny, all products will have a unique identifier number and devices without a medical purpose, such as colored contact lenses, will have to comply with the directive.
While welcoming the reforms, Serge Bernasconi, CEO of industry association MedTech Europe warned that they were bureaucratic: “Implementation will require substantial resources from all stakeholders, including industry. It is thus essential to keep the overarching goals of patient safety and innovation in mind during the translation into implementable rules.”
German Christian Democrat Peter Liese, who was a medical doctor before becoming a member of the European parliament, commented: “The new regulation is good for patients, puts an end to fraudulent and shady producers and thereby also strengthens respectable producers.”