RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

  • 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

    UK’s MHRA Introduces Re-Manufacturing of Single-Use Devices

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday said that single-use medical devices may be re-manufactured for use in the UK, though the remanufacturers should meet all relevant criteria under the appropriate device directives and place a CE mark on their product. The shift to allow such re-manufacturing comes with new guidance from MHRA, which notes that the re-manufacturing of single-use devices and similar processes have existed outsid...
  • 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...
  • Regulatory NewsRegulatory News

    FDA Releases Draft Guidance on Injectable Drug Dose Labeling

    Citing safety concerns, the US Food and Drug Administration (FDA) is updating its guidance to industry on how to properly label injectable drugs for their appropriate doses. The guidance also updates the agency's definition of single- and multiple-dose containers and retires the term "single-use," in favor of the term "single-patient-use," which the agency says will reduce confusion for some products. Single-Patient-Use The introduction of this new term, "single-patien...
  • 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

    New Health Canada Rules Cover Single-Use Reprocessed Devices

    Content provided by  Emergo , a medical deviceregulatory affairs and quality assurance consulting firm with offices worldwide. Canadian medical device market regulator Health Canada will begin requiring all reprocessed single-use medical devices to follow Canadian Medical Device Regulations (CMDR) by 1 September 2016. According to Canadian medical technology trade group MEDEC, the new  requirement  will apply to all commercially reprocessed single-use devices, but...