European Medical Devices Guidelines

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Medical devices | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

Jan 25, 2023

Guidance - MDCG endorsed documents and other guidance

https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en

This page provides a range of documents to assist stakeholders in applying Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 (IVDR) on in vitro …

MDCG 2021-24 - Guidance on classification of medical devices

https://health.ec.europa.eu/latest-updates/mdcg-2021-24-guidance-classification-medical-devices-2021-10-04_en

MDCG 2021-24 - Guidance on classification of medical devices 1 DECEMBER 2021 mdcg_2021-24_en.pdf English (1.52 MB - PDF) Download Details …

New Regulations - Public Health

https://health.ec.europa.eu/medical-devices-sector/new-regulations_en

Medical Devices - Sector - Public Health

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

The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively... New Regulations …

The European Union Medical Device Regulation – …

https://eumdr.com/

The European Commission published IMPLEMENTING DECISION (EU) 2019/939, designating four entities to assign Unique Device Identifiers (UDIs) to medical devices …

Guidance – The European Union Medical Device …

https://eumdr.com/guidance/

The Medical Device Coordination Group (MDCG) of experts have published guidance on a range of topics including the following: Borderline and classification. Clinical …

GUIDELINES ON MEDICAL DEVICES - European …

https://ec.europa.eu/docsroom/documents/10336/attachments/1/translations/en/renditions/pdf

Given the wide diversity of medical devices and their associated risks, this document is not intended to provide comprehensive guidance for clinical investigations of specific medical …

Directives - Public Health

https://health.ec.europa.eu/medical-devices-sector/directives_en

The European Commission and EU countries have taken joint action to tighten controls, provide a better guarantee for the safety of medical devices, and restore confidence as …

MEDICAL DEVICES : Guidance document

https://ec.europa.eu/docsroom/documents/10288/attachments/1/translations/en/renditions/pdf

The medical devices directives (MDD, AIMD, [draft IVD]) each require a statementgiven on the label and/or the information provided with the device on any time limitationon the safe …

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