Plenary session endorsed essential measures that strengthen patient safety and improved the approaches on the approval system. The vote still leaves significant questions regarding the safety level for re-processing of medical devices. Overall, with this vote Parliament creates a good basis for constructive discussions and further improvements with Member States
Brussels, 12 September 2013 – The results of a survey amongst medical device companies in Europe about the financial impact of the upcoming changes in the European medical device regulation show a significant increase in costs for bringing new devices to patients. In addition to the necessary € 7.5 billion investment to ensure the safety of patients, a shocking additional € 17.5 billion would be necessary to finance a centralised pre-marketing authorisation system as proposed by the European Parliament’s Rapporteur. Research shows that such an authorisation system does not improve patient safety and makes patients wait unnecessarily 3-5 years before receiving lifesaving medical devices. The result of such an enormous unnecessary increase in costs will most likely be a drain of innovation and leaving Europe with less SMEs, jobs and less R&D capabilities, ultimately leading to less treatment options for patients.
The European medical technology industry association Eucomed takes note of the measures proposed by Rapporteur Mrs Roth-Behrendt in her draft report on medical devices for the Committee on the Environment, Public Health and Food Safety (ENVI) of the European Parliament. The draft report is a step backward for patients, healthcare systems and Europe. The Rapporteur calls for a shift towards a centralised pre-market authorisation system which if carried through to the final legal text will confront patients in Europe with unnecessary delays of lifesaving medical devices reaching them without improving safety. In addition, the measure would lead to the creation of a new enormous bureaucratic system with no benefits. Important to note is that this is not the final report but the position of the Rapporteur, who will now enter discussions with her Parliamentary colleagues of the ENVI Committee on the content of the report. Members of the ENVI Committee will debate the report, table amendments and vote on the final version, after which it will be voted on in a plenary session of the European Parliament.
Eucomed, the European medical technology industry association, welcomes stakeholder calls at a public hearing of the European Parliament’s Environment, Public Health and Food Safety (ENVI) Committee on 26 February, for much needed improvements to Europe’s regulatory system for medical devices. Physicians, patient groups and industry made clear their desire for a system that improves patient safety, protects patient access to life-saving medical technology and increases transparency and device traceability. Various stakeholder groups noted that a centralised authorisation system for high risk devices would not lead to the desired increase of safety and bring unnecessary delays in patient access of medical technologies. Research shows that a centralised system does not increase safety and patients subject to such a system wait on average at least three years longer for receiving life-saving medical devices compared to patients in Europe.