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Regulatory Affairs, Medical Devices

MDR and IVDR: Onsite or offsite audits? That’s the question.

Posted by on 19 January 2021
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On January 11, 2021, the EU Commission has published a notice in the Official Journal of the EU on the application of Sections 2.3 and 3.3 of Annex IX to Regulation (EU) 2017/745 and Regulation (EU) 2017/746 with regard to Notified Bodies’ audits performed in the context of quality management system (QMS) assessment.

These sections in the Regulations are relevant for manufacturers and Notified Bodies, as they lay down QMS requirements, that need to be assessed by a Notified Body as part of the conformity assessment procedure conform Article 52 of the MDR and Article 48 of the IVDR. As clarified in this notice, the audits by the Notified body need to be performed “on the manufacturer’s premises”.

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