Devicemakers across the EU should brace themselves for increased surveillance by competent authorities, including unannounced inspections, additional testing of products already on the market and heightened controls of notified bodies, the European Commission said following receipt of a “rapid scientific opinion” on the safety of faulty silicone breast implants.

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EC Seeks More Data on PIP Implants, Plans to Ramp up Device Vigilance

Citing the availability of safer alternatives, the European Commission is proposing a near-total ban on mercury measuring devices, beginning Aug. 1.

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EU Reg Would Ban Mercury in Sphygmomanometers

The Mexican government has declassified nearly 1,700 medical devices, clearing the way for regulator COFEPRIS to move forward on a significant backlog of device registrations.

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Mexico Waives Registration for Almost 1,700 Medical Devices

The UK’s National Institute for Health and Clinical Excellence (NICE) issued the first-ever fully positive recommendation under its diagnostics assessment program, with Jan. 25 guidance on four cardiac CT scanners.

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NICE Gives Thumbs Up on Cardiac CT Scanners

Concerns about the future of the U.S. Food and Drug Administration’s (FDA) 510(k) process appear to have been put to rest with the recent issuance of a draft guidance on evaluating substantial equivalence in 510(k)s.

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510(k) Flow Chart Explains U.S. FDA Review Process