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  • 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...
  • 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    The Medicines and Healthcare Products Regulatory Agency (MHRA) has launched a survey to gather input on its new draft guidance on the re-manufacturing of single-use devices.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...