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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