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.