MEPs propose tough controls for medical devices - .PDF file.
The European Parliament’s standing committee on environment, public health and food safety (ENVI) has voted to approve a suite of amendments to the draft European legislation governing medical devices.
The existing regulatory framework dates back to the 1990s. The European Commission put forward two new draft regulations in September 2012, which proposed a tightening up, but not a radical overhaul, of the legislation. This review of the legislation has been proceeding in parallel with the well-publicised PIP breast implant scandal and concern over metal-on-metal hip implants. Two of the key aims of the legislation have therefore been to address a perceived need for tougher regulations to protect patients, while still enabling new, life-saving devices to enter the market in a timely fashion.
Numerous amendments to the European Commission’s proposals have since been proposed and these were voted on one by one by ENVI. The text of the adopted amendments is expected to be published shortly…
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