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Medical Devices - Topics of Interest
Medical Devices - Topics of Interest
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Medical Devices - EUDAMED
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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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Nyhetsbrev
Nyhetsbrev
Nyhetsbrev
Thu, 04/15/2021
Förebygga, skydda och vaccinera: Europeiska vaccinationsveckan 2021
Nytt på sajten
Infographic - Is your software a Medical Device?
Utlagt
23 Mars 2021
Updated version - Information on the applications for designation as a notified body (short overview)
Utlagt
08 Mars 2021
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Getting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities
Commission Notice on notified bodies’ audits performed during Covid-19 exceptional circumstances
Commission guidelines on Union-wide derogations for medical devices
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