www.eubusiness.com 22 October 2013 by BEUC
Parliament opens the door to safer medical devices
Laws defining medical devices will be shaken up after the European Parliament adopted the proposals in Strasbourg today. It is now over to the Council of Ministers to toughen up patient safety.
Pacemakers, pregnancy tests and hip prostheses are just a few of the medical devices that can ease consumers’ lives, provided they are safe and effective. Hence the necessity for strong measures to ensure medical devices on the EU market are safe and reliable.
Patients’ safety has become even more blatantly required since the PIP breast implant scandal hit the headlines in 2012. The thousands of women across Europe who had faulty silicon breasts implanted are still seeking compensation.
Although BEUC called for much more stringent measures on the authorisation of medical devices before they are marketed, the compromise reached by the European Parliament can still pave the way to increased safety.
Monique Goyens, Director General of The European Consumer Organisation (BEUC), commented:
“Today’s vote finally enhances both consumers’ information and involvement in the monitoring of such devices. For example, the ‘implant card’ will provide patients with better information on the medical device they are about to get fitted. Also, reporting defective products will be made possible for patients, enabling manufacturers to learn from their mistakes and innovate with safer products.
“However, we expected MEPs to take a bolder stance on granting consumers access to safer medical devices. Although the surveillance of devices once they are implanted will be considerably beefed up, the same cannot be said about the pre-market phase. Despite our repeated calls, there will still be no thorough evaluation of the risks and benefits of a device before it is used. Under the current system, consumers will continue to be used as guinea pigs.
“We now urge the Council to push for stricter pre-market assessment to truly protect European consumers. Moreover, The EU should say ‘never again’ to unfortunate episodes like the faulty breast implants fiasco and act accordingly.”
BEUC, The European Consumer Organisation has a membership of 41 well respected, independent national consumer organisations from 31 European countries (EU, EEA and applicant countries). BEUC acts as the umbrella group in Brussels for these organisations and our main task is to represent our members and defend the interests of all Europe’s consumers.
MEPs move to tighten controls after implant scare
23 October 2013, 00:32 CET
(STRASBOURG) – The European Parliament moved Tuesday to tighten controls on the safety of medical devices in the wake of a worldwide scare over faulty breast implants from France.
More than 16,000 women have had breast implants removed since it was found in 2011 that those from France’s Poly Implant Prothese (PIP) were twice as likely to rupture as rival brands.
The European Commission set out new rules in September for authorities responsible for the inspection of 10,000 medical devices — from plasters to pacemakers.
The vote to tighten controls on breast or hip implants and on devices used in pregnancy or for DNA testing now requires the go-ahead from European Union member states.
“Doctors have been telling us that hundreds of hip replacements are defective and have to be taken out again, with huge expenses for the health systems and suffering for patients,” said Dagmar Roth-Behrendt.
“We need a better system,” added the German Socialist MEP, who is leading scrutiny of draft legislation for the 28-state bloc.
The Parliament said it was a case of “lessons learnt from the PIP breast implant scandal”, which led to company founder Jean-Claude Mas being charged with manslaughter and fraud.
PIP’s implants were banned and the company was liquidated.
MEPs want patients to receive an “implant card” and to be registered, so that they can be alerted if any incidents are reported.
Organisations in charge of assessing medical devices will have to employ a permanent team of in-house experts under the proposed changes.
The legislation on testing, is to cut down on, for example, faulty HIV assessment, said another German MEP Peter Lierse.
Further information, European Parliament
Adopted text will be available here (click on 22.10.2013)
Procedure file on medical devices
Procedure file on IVD medical devices