• 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 ...
  • IVDR requirements for SOFTWARE

    24 April 2020 IVDR
    Software fulfilling the definition of an in vitro diagnostic medical device falls under the In ...