• Trend reporting in IVDR context and Requirements

    11 May 2022 IVDR
       Introduction: Manufacturers of devices, made available on the Union market, ...
  • IVDR: Latest plan of action from MDCG

    19 April 2022 IVDR
      Set A – Essential ...
  • Is your Diagnostic State-of-Art? Are you sure & you think you can convince you NB?

    24 February 2022 IVDR
    You being "SURE", or your company thinks their Products have SOA does not help as it needs to be ...
  • MHRA: Registration requirements for IVDs

    10 June 2021 IVDR
    The UK Medicines and Healthcare products Regulatory Agency (MHRA) updated the guidance on ...
  • Is your Diagnostic State-of-Art?

    1 March 2021 IVDR
    Are you sure from IVDR perspective ? You being “SURE”, or your company thinks their ...
  • IVD Clinical Performance Studies for FDA & EU

    2 June 2020 IVDR
    At present, the regulatory discussion pretty much focuses on MDR Regulation (EU) 2017/745 on ...