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”.