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Health & Consumer Voice - September/October - 2012 Edition

Patient safety: Commission proposes tighter rules for medical devices

Patient safety

Two new proposals to boost safety, efficiency and innovation in medical devices and in vitro diagnostic devices were adopted by the European Commission on 26 September. They will increase patient safety and make the legal framework for medical devices stronger, more transparent and better adapted to scientific and technological progress.

Referring to the recent scandal involving fraudulent breast implants which affected tens of thousands of women in the EU, Commissioner for Health and Consumer Policy, John Dalli, said the new proposals would “ensure that only safe devices are placed on the European Union’s market”.

At the same time, they will foster innovation and maintain the competitiveness of the EU’s medical device sector which currently has an estimated market value of around €95 billion.

What is a medical device?

Plasters, breast implants, glasses, pacemakers, X-ray machines…a medical device is an instrument, apparatus, implant, or similar device used for the diagnosis, treatment, cure or prevention of disease or other conditions. In vitro medical devices include diagnostic tests e.g. blood tests for cholesterol & HIV and home pregnancy tests. There are around 500 000 different medical devices on the EU market.

The proposals include:

  • Clearer rights and responsibilities for manufacturers, importers and distributors,
  • Stricter requirements for clinical evidence,
  • Improved traceability,
  • More rigorous and regular checks on manufacturers,
  • Better co-ordination between national surveillance authorities,
  • Better supervision of the bodies in charge of assessing medical devices,
  • A comprehensive, public database on medical devices available on the EU market.

Next steps

The Commission’s proposals will be discussed in the European Parliament and Council. They are expected to be adopted in 2014 and will start entering into force in 2015.

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