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:

  • More stringent and aligned procedures that can deliver patient safety without risking delays for accessing life-saving devices
  • Transparency throughout the authorisation process, including access to and disclosure of key information about medical devices for the public and health professionals via a comprehensive and interoperable EU databank system
  • Stricter controls and mandatory reporting and operational requirements for manufacturers and Notified Bodies
  • Obligatory involvement of independent ethics committees in authorising clinical investigations / performance studies
  • Including patients and health professionals as an integral part of the governance structure for medical devices
  • Ensuring that information on medical devices and instructions is clear, consistent and understandable for lay persons, especially concerning self-testing IVD devices; and
  • Expanding the mandate of the Medical Devices Coordination Group to ensure better supervision of activities

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.

- Updated EPHA Position on Medical Devices

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Last modified on August 29 2013.