Taylor: MEPs focus on patient safety in medical devices vote

MEPs today agreed to enter negotiations with national governments on new rules for the safety and performance of medical devices and in-vitro diagnostic devices.

Lib Dem MEPs in particular stressed the need to act to try to prevent health scares like last year’s faulty breast implants scandal by undertaking stricter market surveillance including unannounced inspections of manufacturers and better traceability rules.

Lib Dem European health spokeswoman Rebecca Taylor, said:

“Patient safety and confidence must be the main focus of any new rules, but we must do this in a way that allows enough flexibility to stimulate innovation and healthy competition within the market. It is vital to strengthen transparency and controls in order to avoid health scares such as the faulty breast implants scandal.

“We need not only to control and approve the standards of medical devices before they hit the market, but also ensure that there is a post-market surveillance in place that monitors devices such as hip implants and pacemakers in order to identify problems that could arise only after several years of use. Data on the use of medical devices needs to be collected and made available in a transparent manner, so that any problems can be identified early and appropriate action taken”.

 Lib Dem MEPs, however, objected to proposals to make some in-vitro diagnostic medical devices such as HIV tests subject to medical prescription. Ms Taylor added:

“It is not in the interests of public health to restrict access to some high risk tests, such as HIV tests. It is right that in the UK HIV tests are easily available in order to reach certain high risk groups.”

Ms Taylor also expressed her disappointment that some of the provisions with regard to genetic testing were overly restrictive. She said:

“The rules adopted today are appropriate for genetic tests, which identify serious inherited genetic disorders, but unsuitable for some other genetic tests such as those which ascertain sensitivity to targeted cancer therapies, or those which inform patients of increased risk for common conditions such as diabetes. These provisions could jeopardise existing routine medical practice in some Member States and choke-off future developments in genetic medicine.”

The text adopted by the Parliament today will now be negotiated with national governments in the coming months.

Note to editors:

In-vitro diagnostic medical devices include tools such as pregnancy tests, blood glucose monitors and, increasingly, genetic screening tests. The European Parliament report adopted today stresses the importance of reliable testing for proper diagnosis and treatment of medical conditions. The report also calls for more transparency in the system of authorisation, and greater coordination in reporting and monitoring between manufacturers and notified bodies in Member States.



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