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Medical Devices - Topics of Interest - Latest updates (34)
RSSUpdated document - Notified Bodies Survey on certifications and applications (MDR/IVDR) (Survey results with data status 11 March 2023)
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
New publication of Harmonised standards under the medical devices Regulations - March 2024
Monitoring of availability of medical devices on the EU market
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 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 30 June 2023)
Updated document - Notified Bodies Survey on certifications and applications (MDR/IVDR) (Survey results with data status 31 March 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
New publication of Harmonised standards under the medical devices Regulations
Update - Coverage of designation codes by MDR/IVDR notified bodies - January 2023
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
Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 - Version2 - December 2022
Notified bodies survey on certifications and applications
Notified bodies survey on certifications and applications
Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (September 2022)
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
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.
The UDI Helpdesk is live. It helps the economic operators in the implementation of the requirements introduced by the new UDI system.