Eu Medical Device Guidance Documents

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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 diagnostic medical devices. The majority of documents on this page are endorsed by the …

Guidance - Public Health

https://health.ec.europa.eu/medical-devices-new-regulations/guidance_en

The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations. These are legally non-binding …

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 …

Medical devices | European Medicines Agency

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

The Medical Devices Regulation applies since 26 May 2021. Manufacturers must comply with the Regulation when placing new medical devices on the market. It …

New Regulations - Public Health

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

The European Union Medical Device Regulation – …

https://eumdr.com/

Several technical EUDAMED documents were published including; a data dictionary, MDR and IVDR data sets, an update to the 2018-1 guidance on Basic UDI and changes, …

MDR Guidance Documents - Medical Device Regulation

https://www.medical-device-regulation.eu/mdr-guidance-documents/

Technical Documentation and Medical Device Regulation – A Guide for Manufacturers to Ensure Technical Documentation Complies with EU Medical Device Regulation …

MDCG endorsed documents - Medical Device Regulation

https://www.medical-device-regulation.eu/mdcg-endorsed-documents/

European Medical Device Nomenclature (EMDN) Implant cards Authorised Representatives, Importers, Distributors In Vitro Diagnostic medical devices (IVD) New …

Medical Devices: Guidance document - European …

https://ec.europa.eu/docsroom/documents/36167/attachments/1/translations/en/renditions/pdf

This document provides guidance for Member States, concerned industry and other stakeholders on a blueprint of an implant card (IC) required by the MDR (Regulation (EU) …

MDCG 2023-3 Questions and Answers on vigilance terms …

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

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

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