• 03-APR-2014

  • SOURCE: S&D Group at European Parliament

Safer Medical Devices for European Citizens

Medical devices and in-vitro diagnostic devices – from breast and hip implants to surgical instruments and pregnancy tests – need to be monitored much more effectively in the European Union. The current legislative framework dates back to the 1990s and new legislation has long been awaited.

Following the Commission's publication of two proposed regulations in September 2012, the European Parliament voted already on them in October 2013 and was waiting to start trilogue negotiations. However, as a result of very slow progress in the Council, we have missed a crucial opportunity to finish the legislative process in first reading before the European elections. Today's plenary vote will only close the first reading and the legislative process will only be closed in second reading.

The Parliament's lead negotiator, S&D MEP Dagmar Roth-Behrendt, said:

"These past few months have been very frustrating and it is now extremely difficult to justify to citizens and patients why the legislative process is taking so long.

"Certainly, there are very technical aspects which need to be looked at. However, there are only a few very controversial issues at stake and I still believe we could have focused on three limited issues in our negotiations in trilogues: firstly, ensuring the safe reprocessing of medical devices; secondly, reinforcing the procedure for the approval of new medical devices; and thirdly strengthening the supervisors, the so-called 'notified bodies', which are responsible for assessing the performance and safety of medical devices.

"Member states have had as much time as we had to make these improvements. However, some delegations seem to have favoured a strategy of delaying the discussions by arguing over every single detail. Whether this is linked to similar lobbying strategies used by some industries here in the Parliament, I cannot judge.

"I deeply regret this very unfortunate delay and this missed opportunity. I am very disappointed as today's vote could have been a very important step for patients in Europe.

"However, overall, we Socialists and Democrats welcome this new legislation as amended by the European Parliament because it will help to achieve our main objective: reinforcing patients' protection against defective products and preventing – as far as possible – further scandals.

"That said, I have been very upset by the dishonest industry campaign arguing that the Parliament's proposals to reinforce the system for approving new medical devices would delay innovation. This is simply untrue!

"Who could seriously believe that high-risk breast, hip or knee implants are currently developed in only a few months? Research, development and gathering clinical data on product safety for these high-risk devices take years before they reach patients. So, adding four months to verify the robustness of the clinical data on some devices is not going to kill innovation as has been claimed so many times over the last few months.

"Now is the time to maintain pressure on the Council so that the second reading can be completed as soon as possible. Patients need this."


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