Brussels, 07/05/2013 (Agence Europe) - The manufacturers of medical devices are not happy with the proposal put forward by Dagmar Roth-Behrendt (S&D, Germany), the rapporteur on medical devices, to create a centralised surveillance body that approves products before they are marketed in the EU, after the fashion of the body that already exists in the United States.
Eucomed, which represents the interests of the medical device industry, states this could “confront patients in Europe with unnecessary delays of lifesaving medical devices reaching them without improving safety”. In addition to the emergence of a huge bureaucratic system that will be of no benefit, Eucomed notes that the text currently only reflects the opinion of the rapporteur given that the relevant EP committee has still to discuss the text (sometime this spring).
Eucomed bases its arguments on several scientific reports which state that submitting devices to the evaluation of a single pre-market authorisation body could entail unbearable delays for the patient. The European authorisation system certainly needs to be improved but a centralised procedure is not a step in the right direction, Eucomed states. The medical device industry takes the view that it is necessary to step up current control procedures by ensuring that assessment bodies fix high quality criteria and that devices undergo testing by independent clinical experts. Eucomed has launched a campaign called “Don't lose the 3” in order to show that it is to the benefit of patients to receive the medical devices they need rapidly, and to highlight that challenges currently raised to improve controls must not make waiting times any longer. “Our current system needs an overhaul but let's keep what works and fix what needs to be improved instead of radically changing the system into something that can't guarantee safety benefits and makes patients unnecessarily wait 3-5 years for their lifesaving medical device”, Eucomed concludes.
In a comment to Euractiv, Roth-Behrendt explains what she is proposing cannot be compared to the American system. “The US system of approval also faces some problems and I have not used it as an example for the changes I propose”, she argued, recalling that faulty devices, such as the PIP breast implants, have managed to obtain market approval and have been inserted into the body of thousands of patients. “We know that many of these high-risk devices are not properly tested before reaching patients and health professionals, (…). This is why I believe that the current EU system of approval for devices with the highest potential risk needs a complete and overall change”, she said. (IL/transl.jl)