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Devicemakers importing goods for sale in Europe will need to comply with a revised hazardous substances directive if they are deemed “free for circulation on the EU market,” an industry guidance says. Read More
Just over a quarter of adverse incidents reported by devicemakers to the UK’s Medicines and Healthcare products Regulatory Agency in 2012 were submitted online, compared with nearly 90 percent of user-generated reports, the agency says. Read More
Citing continuing confusion among devicemakers regarding borderline products, the UK’s Medicines and Healthcare products Regulatory Agency last month issued guidance clarifying when they qualify as a medical device in the EU. Read More
Devicemakers should note whether changes to premarket approval devices were due to enhancement, product complaints or adverse events when preparing their annual reports to the U.S. Food and Drug Administration, according to guidance issued Feb. 10. Read More
Russian officials have issued new procedures for conformity assessment of medical devices, spelling out requirements for technical and toxicological testing and clinical studies. Read More
Medtech companies that make modest improvements to their products will, in most cases, not need to file a new 510(k) with the U.S. Food and Drug Administration, a Feb. 25 report to Congress says. Read More
Devicemakers planning a premarket approval application or product development protocol should take advantage of presubmission meetings with the U.S. Food and Drug Administration to pin down exactly what data the agency expects to support safety and efficacy of a new product. Read More
Citing the growing complexity of medical devices, the U.S. Food and Drug Administration says it will create a devices-only enforcement unit with subspecialists, where necessary, “to carry out effective oversight” of manufacturers. Read More
Devicemakers should take steps now to secure a production account for submitting electronic Medical Device Reports, ahead of an Aug. 14, 2015 deadline for compliance with mandatory eMDRs. Read More
India’s Ministry of Health and Family Welfare has begun publishing data about compensation paid in clinical trial-related deaths, with the first wave of data covering 2010 into 2013. Read More
U.S. Food and Drug Administration Commissioner Margaret Hamburg said her 10-day trip to India succeeded in syncing U.S.-India views on quality of medical products. Read More
It appears highly likely that the European Parliament won’t finalize the proposed medical device and IVD regulations before May elections, a lawyer familiar with the legislation says. Read More