EU:s folkhälsopolitik

Improving health systems

Hälsofrämjande insatser

Medical devices

Substances of human origin

Blod, vävnader och organ

Läkemedel

Insatser mot sjukdomar

Riskbedömning

Vetenskapliga kommittéer

Endocrine disruptors

Endocrine disruptors

Biocides

Biocides

Nytt på sajten

04 oktober 2021

The EUDAMED UDI/Devices and NBs & Certificates modules are open. Economic Operators and Notified Bodies can start entering data in EUDAMED on voluntary basis
03 september 2021

The expert panel in the field of in vitro diagnostic medical devices now accepts submissions from notified bodies for the Performance Evaluation Consultation Procedure
20 juli 2021

First references of harmonised European standards in support of Regulation (EU) 2017/746 published in the OJEU: Commission Implementing Decision (EU) 2021/1195 of 19 July 2021
20 juli 2021

First references of harmonised European standards in support of Regulation (EU) 2017/745 published in the OJEU: Commission Implementing Decision (EU) 2021/1182 of 16 July 2021
15 juni 2021

European Medical Device Nomenclature (EMDN) - Questions and Answers
18 Maj 2021

The UDI Helpdesk is live. It helps the economic operators in the implementation of the requirements introduced by the new UDI system.
30 april 2021

Factsheet for Manufacturers of Implantable Medical Devices
28 april 2021

Factsheet for Class I - Medical Devices
23 Mars 2021

Infographic - Is your software a Medical Device?
08 Mars 2021

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

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