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Medical devices regulation

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SPECIAL REPORT / A vote in the European Parliament's Environment, Public Health and Food Safety (ENVI) Committee over the EU's proposed new medical devices regulation, which was supposed to take place on 10 July, has been postponed until September to give lawmakers more time to work on compromise amendments.

SPECIAL REPORT / The European medical technology industry worries that a centralised pre-market authorisation system in Europe will destroy innovation, research and development within the sector. It warns especially that small and medium-sized enterprises (SMEs) could disappear with the proposed new system.

SPECIAL REPORT / The scrutiny procedure on medical devices in the US is so strict that American doctors say the system works against the interest of patients, leaving some waiting years for treatment that could save their lives. European doctors now start to worry that a similar system envisaged in the EU could have the same impact.

SPECIAL REPORT / Recent health scandals involving faulty breast implants and toxic replacement hips have illustrated the need to strengthen safety checks on medical devices in the EU, according to patient groups. A new EU regulation currently in the works must rectify this by putting patient safety first, they argue.

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Opinion & Analysis

More work needed to ensure safe medical devices in Europe

Monique Goyens, Director-General, European Consumers' Organisation (BEUC)

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