Members of European Parliament (MEPs) approved stricter rules Wednesday on medical devices, including breast and hip implants, following high-profile scandals that called into question safety procedures being followed in the European Union.
Meeting for its plenary session in Strasbourg, the European Parliament passed the new legislation to ensure that medical devices were subject to higher standards in the authorization process and would have improved traceability once they reached the market.
In the PIP breast implant scandal, a now defunct French company sold faulty breast implants, which used industrial grade silicon and had a rupture rate roughly twice the average. It is believed that as many as 300,000 women in 65 countries had received the implants, and the company's founder has been sentenced to 4 years in prison for fraud.
Glenis Willmott (Socialists & Democrats, United Kingdom), the medical devices rapporteur for the European Parliament, explained that such scandals have revealed weaknesses in EU systems of control.
“We've introduced much stricter requirements for the bodies that authorize medical devices, and will insist that particularly high risk devices, such as implants, joint replacements or insulin pumps, be subject to additional expert assessments before they can be authorized,” Willmott said.
In addition to greater controls on authorization, the new legislation includes measures to help empower patients and medical professionals to monitor safety risks if problems arise.
“We've also agreed a much stronger system of post-market surveillance so that any unexpected problems are identified and dealt with as soon as possible,” Willmott said.
With the PIP breast implants scandal, many women simply didn't know if they had received defective implants or not, Willmott said.
“So we've also introduced a Unique Device Identification system to help trace patients, who will also be given an implant card, which they can use to access information via a publicly accessible database.”
In order to reinforce the weaknesses revealed in the recent scandals, the new legislation will implement several new safety measures.
There will now be random inspections of producers' facilities once the device has been placed on the market. Stricter controls will be placed on notified bodies, who will be required to hire medically qualified personnel.
A special committee of experts will add an additional safety checking procedure for high risk devices such as implants or HIV tests.
An “implant card” will help them patients and their doctors track which products have been implanted, and clinical evidence of the safety of a device will have to be provided by manufacturers, a procedure already in place for medicines.
Mairead McGuinness (UK), MEP in charge of Medical Products Regulation for the European People's Party group (EPP), celebrated the culmination of 4 years of intense negotiations, but still insisted on the steps needed to implement the new legislation effectively.
“It is absolutely essential that this new Regulation, which is quite complex, is implemented correctly across the EU. For that to happen, the European Commission must assign adequate resources to monitor its application and member states also need to ensure that their industry complies,” McGuinness affirmed.
A separate law will apply the new rules to in-vitro diagnostic medical devices, those not in direct contact with the patient, but which provide health information, such as HIV, DNA or blood testing devices.
“The new regulation is good for patients, puts an end to fraudulent and shady producers and thus also strengthens respectable producers,” said Peter Liese (EPP, Germany), rapporteur for in-vitro diagnostic medical devices.
The consequences of DNA tests will now also be required to be communicated to patients before procedures.
“DNA tests can have severe consequences for patients' lives and they should not be carried out without proper information and counseling... It is important that member states fulfill this obligation. We will be very vigilant on this question”, Liese said.