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Productwise Bitesize: In Vitro Diagnostic Medical Devices Regulation - Life Sciences, Biotechnology & Nanotechnology

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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Global virtual conference on track – Effective care with the EU's in vitro diagnostics regulation

Global virtual conference on track – Effective care with the EU's in vitro diagnostics regulation
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Remote QMS audits under the MDR are finally allowed by the European Commission | Hogan Lovells

[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 ....

Hogan Lovells , European Commission Notice , Devices Coordination Group , European Commission , Medical Devices Coordination Group , Medical Devices Regulations , ஹோகன் லவ்ல்ஸ் , ஐரோப்பிய தரகு அறிவிப்பு , சாதனங்கள் ஒருங்கிணைப்பு குழு , ஐரோப்பிய தரகு , மருத்துவ சாதனங்கள் ஒருங்கிணைப்பு குழு , மருத்துவ சாதனங்கள் ஒழுங்குமுறைகள் ,