EC Flags

Warning – For risk class I devices!

Products, which stay class I under the MDR, must be in full compliance by May 26 2020! MDSS concern: Some clients seem to be under the impression that there was an extension given until May 2024 due to the MDR second corrigendum. This is not true. MDSS concern: Clients who have class I devices and ...

For risk class I manufacturer!

  Warning: No additional  transition for risk class I products.  Products who are risk class I and stay of risk class I must fully comply to the MDR by May 2020. Please consider the MDCG guidance Guidance Notes for Manufacturers of Class I Medical Devices cover.pdf – December 2019. I...