International Medical Device Regulatory Monitor

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.

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

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.

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.

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U.S. Food and Drug Administration’s (FDA) 510(k) process appear to have been put to rest with the recent issuance of a draft guidance on evaluating substantial equivalence in 510(k)s.

EU classification of in vitro diagnostic devices will go from being list-based to risk-based under planned revisions to the IVD directive (IVDD), a regulatory expert says.

Eucomed and the European Diagnostic Manufacturers Association (EDMA) hope to strengthen their voice on revisions to the EU medical device directives and other regulatory and policy matters via the formation of a joint European industry federation.

U.S. and European devicemakers should establish compliance programs integrating individual risk analyses with local laws to ensure ethical interactions with third-party distributors, an AdvaMed-Eucomed joint guidance states.

A proposed Indian rule that would let ethics committees decide the cause of serious adverse events (SAE) and the level of SAE compensation provided to trial participants could make conducting high quality, scientifically valid trials in the country impossible, the Association of Clinical Research Organizations (ACRO) says. Includes the full text of ACRO's Letter on Study-Related Injuries Rule and India's Rule on Study-Related Injures.

An updated Health Canada guidance provides advice on when to include or exclude women from device and drug trials, including women who are pregnant or breastfeeding.

The Danish Medicines Agency will inform applicants for device clinical trials within 60 days whether or not their trial plan is approved, according to a recent guidance.

A compromise reached by the FDA and device industry on medical device user fee reauthorization should benefit both parties and speed patient access to innovative technologies, AdvaMed President Stephen Ubl said.

The U.S. Supreme Court could choke off one mechanism devicemakers and other medical products companies use to appeal patent denials.