Latest updates

News announcement
2023 m. lapkričio 9 d.

Updated document - Notified Bodies Survey on certifications and applications (MDR/IVDR) (Survey results with data status 30 June 2023)

News announcement
2023 m. spalio 12 d.

Updated version - Information on the applications for designation as a notified body (short overview)

News announcement
2023 m. liepos 25 d.

Updated document - Notified Bodies Survey on certifications and applications (MDR/IVDR) (Survey results with data status 31 March 2023)

News announcement
2023 m. liepos 6 d.

New publication of Harmonised standards under the medical devices Regulations

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MD Topics of Interest - Highlights

Man behind desk answering the phone with headphones

The UDI Helpdesk is live. It helps the economic operators in the implementation of the requirements introduced by the new UDI system.

Person holding a tablet and stylus checking medical data

Getting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities

covid-19 virus

Commission Notice on notified bodies’ audits performed during Covid-19 exceptional circumstances

Medical instrument to measure blood pressure

General publications
2020 m. liepos 12 d.

Commission guidelines on Union-wide derogations for medical devices

Medical devices and instruments

General publications
2020 m. birželio 26 d.

List of COVID-19 essential Medical Devices (MDs and IVDs)

Documents

Publications