European Commission Notified Bodies Medical Devices

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Notified Bodies - Public Health

https://health.ec.europa.eu/medical-devices-topics-interest/notified-bodies_en

A notified body is an organisation designated by an EU Member State (or by other countries under specific agreements) to assess the conformity of certain products before being placed on the market. These bodies are entitled to carry out …

Notified Bodies and Certificates module - Public Health

https://health.ec.europa.eu/medical-devices-eudamed/notified-bodies-and-certificates-module_en

Notified Bodies and Certificates Page contents Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices …

Medical Devices - EUDAMED - Public Health

https://health.ec.europa.eu/medical-devices-eudamed_en

EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746… Actors …

EUROPA - European Commission - Growth - Regulatory …

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35

European Commission - This website provides information on the EU's enterprise policy, entrepreneurship, business support, innovation, standardisation and e-business. …

Medical Device Coordination Group Working Groups - Public Health

https://health.ec.europa.eu/medical-devices-dialogue-between-interested-parties/medical-device-coordination-group-working-groups_en

Notified bodies oversight (NBO) Standards Clinical investigation and evaluation (CIE) Post-market surveillance and vigilance (PMSV) Market Surveillance (MS) Borderline and …

EUROPA - European Commission - Growth - Regulatory …

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34

EUROPA - European Commission - Growth - Regulatory policy - NANDO Internal Market, Industry, Entrepreneurship and SMEs Bodies Found : 37 …

MDCG 2023-3 Questions and Answers on vigilance terms …

https://health.ec.europa.eu/system/files/2023-02/mdcg_2023-3_en_0.pdf

February 2023 This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is …

European Parliament votes to extend MDR transition period

https://www.raps.org/news-and-articles/news-articles/2023/2/european-parliament-votes-to-extend-mdr-transition

2 days ago · Vollebregt added that the European Parliament may also want to call on the EU Commission to adopt additional legislation to fix problems that persist in the device …

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European Commission Notified Bodies Medical Devices

Notified Bodies - Public Health

Notified Bodies and Certificates module - Public Health

Medical Devices - EUDAMED - Public Health

EUROPA - European Commission - Growth - Regulatory …

Medical Device Coordination Group Working Groups - Public Health

EUROPA - European Commission - Growth - Regulatory …

MDCG 2023-3 Questions and Answers on vigilance terms …

European Parliament votes to extend MDR transition period

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