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.
The medical technology industry represented by AdvaMed, COCIR, Eucomed, EDMA and MITA met yesterday with senior U.S. and E.U. government officials as part of the U.S.-E.U. High Level Regulatory Cooperation Forum urging them to consider regulatory convergence for medical technology in upcoming negotiations on the Transatlantic Trade and Investment Partnership (TTIP).
Eucomed, the European Medical Technology Industry Association, announced today the launch of its Reimbursement Portal, a visual overview of national reimbursement systems and critical information on how to obtain reimbursement in these European and neighbouring countries. Available at fundingmedtech.eu, the service enables medical device manufacturers to develop a better understanding of the process of obtaining reimbursement, allowing them to develop more effective funding and reimbursement strategies. Eucomed members can benefit from a special discount up to 30%, while other medical device manufacturers who are member of Eucomed’s national association members will receive a discount up to 20%.
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.
Delaying Total Hip Replacement surgery (THR) in people with osteoarthritis (OA) as a way to cut costs is ineffective and denies patients the benefits of an active and healthy life. Moreover, young adults do not benefit from postponing the treatment to avoid revision surgery in later life as the majority of younger people will never have to undergo revision surgery with current technology.