The European Parliament adopted tougher EU standards on medical products today. There will be tighter controls of the safety of products, such as breast implants, not only prior to authorisation, but also as unannounced inspections later at the production sites. A passport will accompany all types of medical implants to make them safer. Furthermore, mandatory counselling ahead of sensitive medical tests will be introduced. The new rules have already been agreed on between Parliament and Council.
"After four years of intense negotiations, the European Parliament has given its final approval to new measures aimed at improving patient safety while encouraging innovation in the sector to ensure that new developments in medical devices can come on to the market. 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", said Mairead McGuinness MEP who is in charge of the Medical Products Regulation for the EPP Group.
"A few weeks ago, the European Court of Justice ruled on the case of the scandal involving PIP’s harmful breast implants. The court determined that until now, notified bodies were not obliged to conduct inspections at company premises. This is going to change with the new EU legislation", said Peter Liese MEP who is the EPP Group Spokesman on the Environment and Health Committee.
The new standards also apply to in-vitro diagnostic medical devices. HIV or DNA tests will be subject to tight controls prior to and after authorisation. In addition, sensitive tests such as on the DNA of embryos will come with a mandatory consultation by a specialist.
"Such sensitive tests may seriously affect a patient's life and they should not be carried out without informing the patient of the consequences of the test. There is also an ethical dimension to it", said Liese who is also the European Parliament Rapporteur on the EU Regulation on in-vitro diagnostic devices.
The new EU rules have been agreed on between Parliament and Council and will enter into force by mid-2020. "The negotiations on the new standards have taken a long time. It is good news that we now have a balanced agreement which can also help boost innovative medical devices in the EU", concluded Peter Liese MEP.