MEPs work on plans to improve the safety and traceability of medical devices such as breast or hip implants and to better inform consumers on DNA testing.

Tougher rules for medical devices

https://api.multimedia.europarl.europa.eu/documents/20125/11590421/n005-160614-001-en.srt

Complications  arising from surgical procedures

caused by faulty devices  are rare but can happen.

Especially as there are  some 25,000 companies

trying to place their products  on the European market.

where cheap industrial silicone  was put into implants,

forced thousands of women  to undergo surgery to have them removed.

that legislation on medical devices  used in all types of medical procedures

ranging from surgeries to diagnostic  examinations needed an overhaul.

Parliament gave its full approval  to a preliminary text in 2014.

and we need the possibility  to give all patients a clear idea

of what will be implanted in their body  in terms of medical devices.

In the past we had no security and  no process for authorisation of devices.

Obligations will be placed  on manufacturers to ensure safety

as well as random inspections on devices.

Patients and doctors will also be given  information on implants

Last autumn final negotiations between  Parliament and Member States began.

The two institutions agreed to place  a legal obligation on the EU Commission

to draw up a list of  devices that cannot be re-used.

But the EU's executive  has some reservations.

They want a negative list, not to have  the possibility to repossess some devices.

It is estimated that by 2060 the number of  people aged over 65 will double

and so ensuring medical devices are  of the best quality is of utmost importance.