European Commission Medical Devices Guidance Document

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 …

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 …

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The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively...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

New Regulations - Public Health

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

DocsRoom - European Commission

https://ec.europa.eu/docsroom/documents/40607

Document detail Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context Document date: Thu Apr 02 …

MEDICAL DEVICES Guidance document …

https://ec.europa.eu/docsroom/documents/10337/attachments/1/translations/en/renditions/native

The manufacturer of a Class I medical device, or his relevant authorised representative in the European Union designated by him, must notify their address and a description of …

MEDICAL DEVICES : Guidance document

https://ec.europa.eu/docsroom/documents/10283/attachments/1/translations/en/renditions/pdf

device for measuring volume or pressure or flow of liquid or gases delivered to orremoved from the human body (included any container with a graduation scale orwith a single …

MDCG 2023-3 Questions and Answers on vigilance terms …

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

Medical Device Coordination Group Document MDCG 2023-3 Page 1 of 18 MDCG 2023-3 Questions and Answers on vigilance terms and concepts as outlined in the Regulation …

MEDICAL DEVICES : Guidance document

https://ec.europa.eu/docsroom/documents/10285/attachments/1/translations/en/renditions/pdf

As a general rule the EMC task force group recommends to consider immunity tests notbeing mandatory for class I devices which by definition do not pose inherent hazard …

Guidance document on in-house devices | mdi Europa

https://mdi-europa.com/guidance-document-on-in-house-devices/

Guidance document on in-house devices | mdi Europa Guidance document on in-house devices February 15, 2023 by Michael Sander In-house devices …