One year after the release of its original position paper, EPHA has revised the document following member discussions about the evolving developments at EU level.
The updated EPHA Position on Medical Devices refers in particular to a number of points contained in the European Parliament reports produced by Rapporteurs Dagmar Roth-Behrendt (S&D, Germany) on medical devices and Peter Liese (S&D, Germany) on in vitro diagnostic medical devices and the subsequent debates over the most appropriate amendments.
That said, the overall stance has not changed and throughout the continuously more detailed discussions EPHA has stressed that it would like to see medical devices Regulations that firmly and unambiguously protect patient safety to ensure that the scandals surrounding medical devices will never repeat themselves and be certain that only the safest and most adequate devices are placed on the market for the benefit of end users, whether these are patient-consumers, carers, health professionals or anybody else who comes into contact with them.
As the line between medicines, medical devices, cosmetics, eHealth and other health tools becomes increasingly blurry, it is also important to ensure that there are no loopholes where non-quality devices can reach patients by bypassing the legislation. The Regulations will thus have to take into account other new or ongoing pieces of EU legislation such as data protection, eHealth/mHealth, pharmacovigilance, etc. and be flexible to adapt to new scientific and technological developments.
Given the diversity of views represented in its membership, EPHA feels that the following points are key to the debate, regardless of what type of marketing authorisation (i.e., the tightening of existing procedures proposed by the Commission vs. pre-market authorisation - PMA - for certain high-risk devices, as proposed by MEP Roth-Behrendt) will be put into place:
EPHA will continue to follow the issue and submit recommendations to MEPs prior to the upcoming vote by the Committee on the Environment, Public Health and Food Safety (ENVI) on 18 September.
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