European Commission Guidelines On Medical Devices

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

Background note on the use of the Manual on borderline and classification for medical devices under the Directives. December 2022: MDCG 2022-5. Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on …

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The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively...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

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 …

Medical Devices - New regulations - Public Health

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

The EU has revised the legal framework of 3 directives to reflect progress over the last 20 years. Getting ready Manufacturer IVD Manufacturers MD Manufacturers …

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 …

Market surveillance and vigilance - Public Health

https://health.ec.europa.eu/medical-devices-sector/directives/market-surveillance-and-vigilance_en

The enforcement of the harmonised legislation on medical devices is the responsibility of the authorities in EU countries. The Medical Devices Directives establish specific …

GUIDELINES ON MEDICAL DEVICES CLINICAL …

https://ec.europa.eu/docsroom/documents/10324/attachments/1/translations/en/renditions/pdf

These guidelines on Clinical Evaluation are part of a set of Medical Device Guidelines that promote a common approach by Manufacturers and Notified Bodies involved in clinical …

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 …

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 …