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Medical Devices - Topics of Interest - Latest updates (35)
RSSA Study and dashboard on reprocessing and reuse of single-use-devices in the EU
Updated document - Notified Bodies Survey on certifications and applications (MDR/IVDR) (Survey results with data status 31 October 2023) - Revised version 11 March 2024
New publication of Harmonised standards under the medical devices Regulations - March 2024
Monitoring of availability of medical devices on the EU market
Updated version - Information on the applications for designation as a notified body (short overview)
Updated document - Notified Bodies Survey on certifications and applications (MDR/IVDR) (Survey results with data status 30 June 2023)
Updated document - Notified Bodies Survey on certifications and applications (MDR/IVDR) (Survey results with data status 31 March 2023)
New publication of Harmonised standards under the medical devices Regulations
Update - Coverage of designation codes by MDR/IVDR notified bodies - January 2023
Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 - Version2 - December 2022
Notified bodies survey on certifications and applications
Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (September 2022)
Update - Short overview of the information on the applications for designation as a notified body
The UDI Helpdesk is live. It helps the economic operators in the implementation of the requirements introduced by the new UDI system.