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Medical Devices - New regulations
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Latest updates
18 January 2021
Getting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities
11 January 2021
Covid-19: Commission Notice on audits to be performed by notified bodies
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 October 2020
New web page with the basic information on the EUDAMED Actor registration module
17 July 2020
Guidance - Clinical evaluation assessment report template
15 July 2020
Factsheet on MDR requirements for Transparency and Public Information
12 July 2020
MDCG 2020-11: Guidance on the renewal of designation and monitoring of notified bodies
10 July 2020
State of play of Joint implementation Plan on actions considered necessary to ensure the sound functioning of the new framework for medical devices under the MDR
e-newsletter
e-newsletter
e-newsletter
Mon, 03/01/2021
Dal produttore al consumatore: una strategia solida per migliorare i nostri sistemi alimentari
Latest updates
Getting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities
Released
18 January 2021
Covid-19: Commission Notice on audits to be performed by notified bodies
Released
11 January 2021
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Highlights
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
New Regulations on medical devices – Factsheets with basic information for all stakeholders
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