Safety of medical devices must be ensured

Following two votes today in the Parliament's Environment Committee on legislation to enhance the safety of medical devices and ensure that member states apply existing EU safety rules consistently, GUE/NGL Shadow rapporteur on the file Alda Sousa has hailed the results has a step in the right direction.

The Roth-Behrendt report, which deals with body implants, such as hip or breast implants, was adopted with 52 votes in favour, 12 against and 3 abstentions, and most importantly, a consolidated amendment co-signed by the GUE/NGL, the S&D, and the Greens, was adopted that seeks to ensure all high-risk devices will be assessed by appropriate bodies.

Sousa said: “Today's vote was a big step forward in ensuring patients' safety, since it guarantees that the same level of rigorous assessment for high-risk devices will prevail across the EU. It is important that plenary confirms this vote.”

The second report, the Liese report, which was adopted with 57 votes in favour and 8 abstentions covers in-vitro medical devices (IVD) which are used for diagnostics outside the human body, such as self-tests for blood sugar levels, HIV and DNA tests.

Sousa added:  “This is an important step forward in ensuring the quality of in vitro diagnosis and to prevent abuses in genetic testing.”