After almost five years of talks with member states, the European Parliament adopted two new regulations on Wednesday (5 April) imposing stricter rules on medical devices’ safety.
The new rules will not enter into force before mid-2020 however, leaving EU patients exposed to potential health risks. The regulations will be fully applicable in three years for medical devices and in five years for in vitro diagnostics.
Medical devices cover a wide range of products, such as sticking plasters, hip replacements, state-of-the-art pacemakers, X-ray machines, pregnancy and genetic tests.
There are over 500,000 medical and in vitro diagnostic devices on the market, according to estimates, while the sector employs over 500,000 people in about 25,000 companies.
A safety scandal involving breast implants in France acted as a wake-up-call for policymakers to speed up the adoption of new EU rules. But according to consumer organisations, it was too little too late.
In January, a French court ordered German safety certifier TUV to pay €60 million to compensate 20,000 women who received defective breast implants, which were previously green-lighted by it.
According to AFP, TUV Rheinland was ordered to make a provisional payment of €3,000 to each plaintiff for certifying that implants made by French firm Poly Implant Prothese (PIP) met safety standards.
In the far-reaching health scandal, the devices were later found to contain substandard, industrial-grade silicone gel that was seven times cheaper than medical-grade silicone.
A big victory for consumers
Ilaria Passarani, the head of Food and Health at the European Consumer Organisation (BEUC), hailed the Parliament’s adoption of the new rules, calling it a big victory for consumers.
The new regulations will boost information to patients and strengthen the way devices are controlled, she said.
“If properly implemented, new rules will help prevent faulty devices from ending up in patients’ bodies and disrupting their lives, like what happened in recent years,” she said, regretting however that stronger safety standards could have been adopted.
She also criticised the lengthy process for adopting the two regulations. “We regret the talks were endless and that the gravity of the scandals did not push decision makers to move on faster and be more ambitious on safety,” she noted, adding that given that the new rules will not be rolled out before 5 years, patients “will remain exposed to potentially harming devices for too long”.
Tracing the devices
Under the new rules, medical devices such as breast or hip implants will be traceable and the post-market surveillance will be reinforced.
British Social-Democrat MEP and rapporteur Glenis Willmott (Socialists & Democrats), commented, “We’ve agreed a much stronger system of post-market surveillance so that any unexpected problems are identified and dealt with as soon as possible”.
She noted that with the PIP breast implants scandal, many women didn’t know if they had received defective implants or not.
“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”, she said.
The new rules, also, provide random inspections of producers’ facilities after devices have been placed on the market, as well as stricter controls on notified bodies, which will have to employ medically skilled people.
Ethical requirements for DNA testing
EU lawmakers also focused on the ethical requirements for diagnostic medical devices, for instance, pregnancy or DNA testing, which from now on will have to be accompanied with a mandatory consultation by a specialist.
EU member states are now required to inform patients of the consequences of DNA tests, but they made it clear that this is primarily their responsibility.
Rapporteur on in-vitro diagnostic medical devices, German CDU lawmaker Peter Liese (EPP), noted that DNA tests could have severe consequences for patients’ lives.
“They should not be carried out without proper information and counseling,” the MEP said emphasising, though, the fact that member states pointed out that it was their responsibility and that they would accept EU rules “only to a certain extent”.
“It is important that member states fulfil this obligation. We will be very vigilant on this question,” Liese warned.
Reacting to the Parliament vote, MedTech Europe, the European trade association representing the medical technology industries, stressed that the new rules would strengthen patient safety and clarify access to new and innovative technologies.
“We welcome this vote that allows industry to begin the work needed to transition the two sectors to the new rules within the set timeframes”, MedTech Europe CEO Serge Bernasconi commented.
Bernasconi added that there was still a lot to do to make these regulations a reality.
“The amount of effort needed from all parties to implement these revised rules cannot be underestimated. Essential elements, like notified body availability to handle the new requirements, should be dealt with outmost urgency,” he noted.
“It is critical that in vitro diagnostics and medical devices are given equivalent level of attention and investment during the development of necessary secondary legislations and European Commission guidance and that pragmatic solutions be found to address the notified bodies’ capacity to handle the enormous flow of new and renewal dossiers that these regulations trigger,” the MedTech chief concluded.
Medical devices are defined broadly and can include anything from plasters to contact lenses, pregnancy tests, dental filling materials, X-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests.
Following a huge health scandal involving faulty breast implants sold around Europe, the European Commission published proposals in late 2012 for a new regulatory regime for medical devices.
On 25 May 2016, the EU agreed to new rules on medical devices and in vitro diagnostic medical devices.
The Netherlands presidency of the Council and representatives of the European Parliament reached a political agreement.