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

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)
18 januari 2021

Getting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities
11 januari 2021

Covid-19: Commission Notice on audits to be performed by notified bodies
11 december 2020

Updated presentation - Information on the applications for designation as a notified body under Regulations (EU) 2017/745 and 2017/746
01 december 2020

The EUDAMED Actor module is in production. On 1st December 2020 the European Commission has made available the Actor registration module to Member States and economic operators
20 oktober 2020

New web page with the basic information on the EUDAMED Actor registration module
13 juli 2020

Survey on availability and capacity of notified bodies to carry out conformity assessments for COVID-19 essential devices
12 juli 2020

Amendment to Implementing Regulation 920/2013 on the designation of notified bodies
12 juli 2020

MDCG 2020-11: Guidance on the renewal of designation and monitoring of notified bodies

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