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Elamine, töötamine ja reisimine ELis
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Medical Devices - Sector
Medical Devices - Sector
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Medical devices
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Medical Devices - EUDAMED
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Viimased uuendused
11 Jaanuar 2021
Covid-19: Commission Notice on audits to be performed by notified bodies
18 Detsember 2020
Updated Implementation Rolling Plan - Regulation (EU) 2017/745 and Regulation (EU) 2017/746
18 Detsember 2020
Updated - Ongoing guidance development within MDCG Subgroups
15 Detsember 2020
MDCG 2020-18 - MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers
02 Detsember 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 Detsember 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 November 2020
Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
20 Oktoober 2020
New web page with the basic information on the EUDAMED Actor registration module
06 Oktoober 2020
EU device specific vigilance guidance on insulin infusion pumps and integrated meter systems
20 August 2020
Commission Implementing Regulation (EU) 2020/1207 of 19 August 2020 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards common specifications for the reprocessing of single-use device
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Fri, 01/15/2021
Tervise ja toiduohutuse peadirektoraat on valmis uuteks suheteks Ühendkuningriigiga / Olulised ettevalmistused tehti enne Brexit
Viimased uuendused
Covid-19: Commission Notice on audits to be performed by notified bodies
Avaldamise kuupäev
11 Jaanuar 2021
Updated - Ongoing guidance development within MDCG Subgroups
Avaldamise kuupäev
18 Detsember 2020
Updated Implementation Rolling Plan - Regulation (EU) 2017/745 and Regulation (EU) 2017/746
Avaldamise kuupäev
18 Detsember 2020
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Aktuaalne
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
New Regulations on medical devices – Factsheets with basic information for all stakeholders
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