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European Parliament agrees on medical devices to enhance patient safety

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Stricter rules to ensure that medical devices such as breast or hip implants are traceable and comply with EU patient safety requirements were backed by MEPs on Wednesday. MEPs also approved laws to tighten up information and ethical requirements for diagnostic medical devices, such as for pregnancy or DNA testing.

"The metal-on-metal hip scandal highlighted weaknesses in the current system. So we’ve introduced much stricter requirements for the bodies that authorise medical devices, and will insist that particularly high risk devices, such as implants, joint replacements or insulin pumps, be subject to additional expert assessments before they can be authorised.”, said medical devices rapporteur Glenis Willmott (S&D, UK).

Stronger post-market surveillance, more information to patients

“We've also agreed a much stronger system of post-market surveillance so that any unexpected problems are identified and dealt with as soon as possible”. “With the PIP breast implants scandal, many women simply didn’t know if they had received defective implants or not. So we’ve also introduced a Unique Device Identification system to help trace patients, who will also be given an implant card, which they can use to access information via a publicly accessible database" added Willmott.

The Commission welcomed the adoption of its proposal for two Regulations on medical devices which establish a more robust EU legislative framework to ensure better protection of public health and patient safety.

The new Regulations were proposed by the Commission in 2012 will help to ensure that all medical devices - from heart valves to sticking plasters to artificial hips – are safe and perform well. To address this, the new rules will improve market surveillance and traceability as well as make sure that all medical and in vitro diagnostic devices are designed to reflect the latest scientific and technological state-of-the art. The rules will also provide more transparency and legal certainty for producers, manufacturers and importers and help to strengthen international competitiveness and innovation in this strategic sector.

Elżbieta Bieńkowska, Commissioner for Internal Market, Industry, Entrepreneurship and SMEs, said: "I'm extremely happy that our push for stricter controls of medical devices on the EU market will now become a reality. Whether for medical devices, cars or other products, we must ensure stronger supervision in the interest of our citizens. We should not wait for another scandal instead we should start a discussion how to strengthen European oversight over Member States' market surveillance activities."

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