Sokol MEP (EPP Group): “The European Commission must ensure that innovative devices enter in the market quickly, following all the safety mechanisms”.

“The Medical Devices Regulation was adopted in 2017, according to it all medical devices such have to be recertified by notified bodies and as including those already present in the market, states in plenary Mr. Tomislav SOKOL MEP (EPP Group, Sant committee coordinator). Because many notified bodies have headquarters in the UK, the result is that the system doesn’t work in practice, which endangers the safety of patients. Individual devices, including those necessary to treat children, have been recalled from the market, which may result in shortages”. 

“The Commissioner-designate, I hope, will recognize the need to revise the situation and implement the existing legislation. The European Commission must react quickly in order to counter the problem and ensure that innovative devices can enter the market quickly, following all the safety mechanisms, of course”.

“Health must – concludes Mr. Sokol MEP – remain a priority in the new mandates, as well. Speeding up proceedings, as part of amending this regulation, is part of this strategy”.