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  • Regulatory NewsRegulatory News

    European Commission sets common specifications for reprocessing single-use devices

    The European Commission this week issued regulations establishing common specifications for the reprocessing of single-use medical devices under the Medical Device Regulation (MDR).   Under MDR, single-use devices may be reprocessed where permitted by national law. Member states may also determine what rules they will apply to single-use devices reprocessed and used within a health institution, so long as the reprocessing is performed in accordance with the common sp...
  • Regulatory NewsRegulatory News

    End in Sight for Discussions Over New EU Medical Device Regulations

    New EU regulations for medical devices and in vitro diagnostics (IVDs) could be adopted as early as next year, a European Commission representative told attendees at RAPS' Regulatory Convergence on Tuesday. The legislation would introduce stricter premarket rules for a range of medical devices, increase the powers and responsibilities of notified bodies and require new clinical evidence in some cases. On 5 October 2015, the Ministers of the EU countries agreed on a gene...
  • MHRA Wants Input on Single-Use Device Re-Manufacture Guidance

    The Medicines and Healthcare Products Regulatory Agency (MHRA) has launched a survey to gather input on its new draft guidance on the re-manufacturing of single-use devices. Note: at the time of publishing, the survey appears to be closed. According to MHRA's announcement the survey should be available until 1 September 2015. Background In the past, medical devices were typically designed to be reusable and were built to withstand cleaning procedures such...
  • Feature ArticlesFeature Articles

    Health Canada to Regulate Reprocessors of Single Use Medical Devices as Manufacturers

    This article explains reasons for reprocessing Single Use Devices (SUDs), major concerns about this practice and the potential impact of these new requirements. For the past several years, the Canadian medical devices industry has opposed reprocessing SUDs strongly, mainly because of unknown safety procedures, although this practice commonly is used in hospitals and by third-party service companies. The Reuse of Single Use Devices Task Force within Canada's medical tec...
  • Regulatory NewsRegulatory News

    After Investigation Reveals Deadly Flaws, FDA Issues Warnings About Duodenoscopes

    US regulators have issued a warning to healthcare providers about design flaws inherent in a type of endoscope which could increase the spread of harmful infections in surgery patients. Background The device, known as an endoscopic retrograde cholangiopancreatography (ERCP) duodenoscope, is a flexible, lighted tube commonly used in surgical procedures to inject contrast dye or to obtain tissue samples. "Unlike most other endoscopes, duodenoscopes also have a movable '...