• Regulatory NewsRegulatory News

    MDR, IVDR: Competent Authorities Lay Out Road Map

    The Competent Authorities for Medical Devices (CAMD) Executive Group’s EU medical device regulation and in vitro diagnostic regulation (MDR/IVDR) implementation task force has released a road map outlining key challenges and steps for various technical work streams. The road map divides the implementation work into eight categories, with activities, recommended responsible parties and owners, and priority levels for each: 1. Clinical Evaluation & Clinical Investi...
  • Regulatory NewsRegulatory News

    Cash-Strapped MHRA Looks to Stay Flexible

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released its business plan for 2016-17, warning of serious financial troubles, particularly as funding for the regulation of medical devices has declined over the past decade and as it's losing revenue from industry because of changes at the EU level. “Funding for devices regulation is at half the level of what it was in 2003 in real terms; and while a number of efficiency measures have been t...