Europe - Aug 2020

  • EU: Notified Body designation renewal process to be eased temporarily

  • EU: Guidelines on the adoption of Union-wide derogations for medical devices

  • EU: Guidance documents from the MDCG

  • EU: Continued use of mercury in electric rotating connectors used in intravascular ultrasound imaging systems likely to be permitted until June 2026

  • EU: Help provided on adapting IT systems to implement new MIR form; enforcement dates for use of IMDRF codes and terms

  • EU: CEN/CENELEC reject Commission’s standardisation request for the MDR and IVDR

  • Spain: Return to usual procedure for importing medical devices

  • Spain: AEMPS launches CERTPS application system for Certificates of Free Sale

  • Spain: Deadline extension for Brexit labelling changes

  • UK: Updated information on when apps are considered medical devices

  • UK: New guidance published on writing and distributing effective FSNs

  • UK: Latest regulatory guidance issued in relation to COVID-19

  • UK: Independent review of device safety recommends reforms to MHRA and establishment of a registry like the Australian ARTG


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