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EU at crossroads on new medical devices legislation

On 1 July, an article entitled “EU at crossroads on new medical devices legislation” was published on the EURACTIV website.

The article explains the main points of the Commission proposal as well as the different opinions taken by the Parliament, representatives of the industry and patients organizations.

  •     Parliament

Dagmar Roth-Behrendt MEP (S&D, Denmark) proposed establishing a centralised pre-market approval procedure for high-risk Class III devices and a Committee for the Authorisation of medical devices within the European Medicines Agency (EMA) to oversee the process, where patients would be represented. According to the MEP, in this new system, authorisation would not be delayed as compared to the current one. It is interesting to note that the idea of a centralised authorisation system for medical devices has been highly criticised both by inudustry and the other major political groups within the European Parliament.

  •     Industry

Serge Bernasconi, chief executive of the European Medical Technology Industry Association (EUCOMED), stated that the industry was in favour of change to improve the management of the current European system, and to keep pace with new medical technologies. However, he argued the proposal by the Parliament rapporteur was not the right way forward; “We need to keep what works (referring to the decentralised system) and fix what needs to be improved instead of radically changing the system”.

  •     Consumers

The European Consumers’ Organisation (BEUC), supporter of safer methods of approval for medical devices following the PIP scandal, agreed with Roth-Behrendt’s call for a centralised pre-market authorisation. The European Patients’ Forum (EPF) questioned the necessity of a centralised system, but welcomed the Parliament rapporteur’s initiative introducing more patient involvement earlier in the process.

  •     Next steps

18 September: The Parliament’s Environment, Public Health and Food Safety (ENVI) Committee will vote to accept its final report.

November 2013: The Parliament will vote to accept or reject the report in plenary session.
The full article is available here.


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