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Medical Devices - Sector
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Últimas actualizações
20 Julho 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
18 Julho 2020
MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States
28 Junho 2020
Checklist for EN 17466 & Validation (Instructions for use for reusable & re-sterilisable medical devices)
17 Junho 2020
Guidance - Clinical evaluation assessment report template
13 Junho 2020
Survey on availability and capacity of notified bodies to carry out conformity assessments for COVID-19 essential devices
26 Abril 2020
The COVID-19 In Vitro Diagnostic Devices and Test Methods Database
16 Abril 2020
Working document: Performance of COVID-19 test methods and devices and proposed performance criteria
15 Abril 2020
Coronavirus: Commission issues guidelines on testing
25 Março 2020
New lists of harmonised standards for medical devices available
20 Março 2020
Coronavirus: European standards for medical supplies made freely available to facilitate increase of production
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Boletim eletrónico
Boletim eletrónico
Boletim eletrónico
Fri, 01/15/2021
DG SANTE pronta para uma nova relação com o Reino Unido/Disposições essenciais em preparação do Brexit
Últimas actualizações
Getting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities
Data de publicação
18 Janeiro 2021
Covid-19: Commission Notice on audits to be performed by notified bodies
Data de publicação
11 Janeiro 2021
Updated - Ongoing guidance development within MDCG Subgroups
Data de publicação
18 Dezembro 2020
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Destaque
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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