Productwise Bitesize brings you a short introduction to the In Vitro Diagnostic Medical Devices Regulation. Since 26 May 2022, this regulation has been applicable to IVDs, .
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[co-author: Silvia López Arnao]
On 11 January 2021, the European Commission published a Notice which provides the conditions under which remote audits under Regulation 2017/745 of 5 April 2017 on medical devices (MDR) and Regulation 2017/746 of the of 5 April 2017 on in vitro diagnostic medical devices (IVDR) may be performed. The European Commission recalls that this is a temporary extraordinary measure motivated by the unprecedented circumstances that the medical devices industry is experiencing due to COVID-19. The possibility of conducting remote audits will, therefore, be assessed on a case-by-case basis and will only be allowed until on-site audits are again possible.
Background for the Notice