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EU revamps medical devices directive


Ban on substances avoided, but rules tighten on labelling.

5 April 2007 - Uniform European Union (EU) rules on re-using and labelling plastic medical devices have been agreed by the European Parliament, revamping the EU medical devices directive to boost patient safety. Although the renewed legislation avoids an outright ban on using materials deemed carcinogenic, mutagenic or toxic to reproduction, the new law clearly instructs they should be avoided where possible.

The key is whether there is an alternative material. A European Commission statement said: "A total ban of these substances is not possible without banning many medical devices which are indispensable for the protection of health." This revised directive covers devices ranging from spectacles, joint and breast implants, to the most sophisticated diagnostic imaging and minimally invasive surgical equipment, including plastic stitching thread.

As regards labelling and re-usage, the new legislation clarifies rules on reprocessing; defines the term "single use"; and insists future medical device labelling be uniform across the EU. Devices which could possibly release phthalates into patientsí bodies should be labeled accordingly.

Other rules within the revamped directive include a commitment for device manufactures to attempt developing alternative substances or products with lower health risks. They are also instructed to design devices with a "particular emphasis on the working environment in which device is used", aiming for a "possible reduction of potential accidents".

Given this package was negotiated with the EU Council of Ministers, formal adoption of these new rules is anticipated shortly. They do not cover medical devices combined with human cells and tissues, which will be covered by separate future legislation under consideration.

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