Medical Device Directive Guidance

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Medical devices | European Medicines Agency

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

The medical device may be co-packaged with, obtained separately from or integral to the medicinal product. EMA issued a final guideline on quality documentation for medicinal products that include a medical device in July 2021. This clarifies expectations …

Guidance Documents (Medical Devices and Radiation …

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products

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The European Union Medical Device Regulation – …

https://eumdr.com/

December 2022: Publication of MDCG 2022-21 Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745.; Update of Manual on borderline and …

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 …

Directives - Public Health

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

MDR Guidance Documents - Medical Device Regulation

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

Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a ‘person responsible for regulatory compliance’ …

Medical Device Directive (MDD)

https://www.medicaldevicesgroup.net/medical-device/MDD_Training_D7-1.pdf

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Guide to Medical Device Directive Compliance …

https://instrktiv.com/en/medical-device-directive/

Medical Device Directive (93/42/EEC) - Certification Guide. 28/5/2019 Ferry Vermeulen Law & Legislation. 1. What is the Medical Devices Directive. The Medical Devices Directive …

MDR Guidance | Medical Device Regulatory Guide

https://www.mdr.guide/mdr

However, the Medical Device Directive (MDD) does not explicitly require this, nor does it contain an explicit requirement to employ risk management, other than for software …

MEDICAL DEVICES Guidance document …

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

Directorate B, Unit B2 “Cosmetics and medical devices” MEDICAL DEVICES: Guidance document - Classification of medical devices . MEDDEV 2. 4/1 Rev. 9 . June 2010 : ...

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