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DG Salute e sicurezza alimentare
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Medical Devices - Sector
Medical Devices - Sector
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Medical Devices - EUDAMED
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Ultimi aggiornamenti
18 Gennaio 2021
Getting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities
11 Gennaio 2021
Covid-19: Commission Notice on audits to be performed by notified bodies
18 Dicembre 2020
Updated Implementation Rolling Plan - Regulation (EU) 2017/745 and Regulation (EU) 2017/746
18 Dicembre 2020
Updated - Ongoing guidance development within MDCG Subgroups
15 Dicembre 2020
MDCG 2020-18 - MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers
02 Dicembre 2020
MDCG 2020-17 - Questions and Answers related to MDCG 2020-4: “Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions”
01 Dicembre 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
13 Novembre 2020
Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
20 Ottobre 2020
New web page with the basic information on the EUDAMED Actor registration module
06 Ottobre 2020
EU device specific vigilance guidance on insulin infusion pumps and integrated meter systems
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e-newsletter
e-newsletter
e-newsletter
Fri, 01/15/2021
I preparativi della DG SANTE per le nuove relazioni con il Regno Unito / Principali provvedimenti adottati in vista della Brexit
Ultimi aggiornamenti
Getting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities
Pubblicazione
18 Gennaio 2021
Covid-19: Commission Notice on audits to be performed by notified bodies
Pubblicazione
11 Gennaio 2021
Updated - Ongoing guidance development within MDCG Subgroups
Pubblicazione
18 Dicembre 2020
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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 Implementing Regulation (EU) 2020/1207 laying down rules as regards common specifications for the reprocessing of single-use devices
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