FDAnews Device Daily Bulletin

The European Parliament and Council are wrapping up their review of a proposed regulation that would ban several types of mercury-containing medical devices because of their potential toxicities. The regulation will soon go to the European Commission (EC) for adoption. EU member states have already approved the ban, which would include the following types of products:

• Sphygmomanometers;
• Strain gauges to be used with plethysmographs;
• Thermometers;
• Metering devices for the determination of softening point; and
• Pycnometers and other atmospheric measuring devices.

International Medical Device Regulatory Monitor