Europe - Feb 2021

  • Belgium: Exceptional measures end for surgical face masks

  • Denmark: Relaxed labelling requirements for medical face masks extended by six months

  • EU: Remote Notified Body audits under MDR and IVDR permitted under limited conditions

  • EU: Questions and answers published on MDCG 2020-4

  • EU: Guidance released to clarify classification rules for IVDs under IVDR

  • EU: EUDAMED’s actor registration module goes live

  • EU: MDCG guidance on UDI assignment for spectacle lenses and ready readers

  • EU: Temporary measures introduced for VAT applicable to COVID-19 IVDs

  • EU: Team-NB offers guidance on when a device-related change may require a new Notified Body opinion under Article 117

  • Ireland: Importing medical devices into Ireland from Great Britain

  • UK: Rules for registering medical devices to place on the market from 1 January 2021

  • UK/India: MoU on co-operation in the field of medical product regulation

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