This site is part of the Informa Connect Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

Notified Body designation and scope, the impact of Brexit and Competent Authority and Notified Body interpretation of the regulations. Make sure you are up to date!

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

Download nowget_app

Share this article

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”.

Download the full whitepaper by clicking 'Download Now' at the top of the page.

Share this article

Sign up for our MedTech Monthly newsletter

Get the latest content and updates straight to your inbox

Upcoming event

MedTech Digital Week

08 - 10 Mar 2021
Explore The Latest EU MDR Insights, Tools And Guidance With This Complimentary 3-Day Webcast Series. Register Now To Watch On-Demand.
Go to site