Search Results related to mdcg guidance on Search Engine
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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
WEBMDCG 2022-5. Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices: April 2022: MDCG 2021-24. Guidance on classification of medical devices: October 2021: Helsinki Procedure. Helsinki Procedure for borderline and classification under MDR & IVDR: September 2021
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MDCG endorsed documents - Medical Device Regulation
https://www.medical-device-regulation.eu/mdcg-endorsed-documents/
WEBMDCG 2022-6: Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR: May 2022: MDCG 2022-3: Verification of manufactured class D IVDs by notified bodies: February 2022: MDCG 2022-2: Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs) January 2022: MDCG ...
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MDCG 2021-24 Guidance on classification of medical …
https://health.ec.europa.eu/system/files/2021-10/mdcg_2021-24_en_0.pdf
WEB1 Purpose of medical device classification. The classification of medical devices in use by the EU medical device legislation is a risk-based system taking into account the vulnerability of the human body and the potential risks associated with the devices.
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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
WEBMDCG 2021-24 - Guidance on classification of medical devices. 1 DECEMBER 2021. mdcg_2021-24_en.pdf. English. (1.52 MB - PDF) Download.
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MDCG 2019-9 Rev - Public Health
https://health.ec.europa.eu/system/files/2022-03/md_mdcg_2019_9_sscp_en.pdf
WEBIntroduction. The Regulation (EU) 2017/745 on medical devices (1) requires that the manufacturer shall draw up a summary of safety and clinical performance (SSCP) for implantable devices and for class III devices, other than custom-made or …
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MDCG 2019-11 - Public Health
https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2019_11_guidance_qualification_classification_software_en_0.pdf
WEBMedical Device Coordination Group Document. MDCG 2019-11. Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR . October 2019. This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of …
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MDCG 2019-7 Guidance on Article 15 of the Medical Device …
https://ec.europa.eu/docsroom/documents/36166/attachments/1/translations/en/renditions/native
WEBGuidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a ‘person responsible for regulatory compliance’ (PRRC) Manufacturers1 (paragraph 1)
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DocsRoom - European Commission - Die Europäische Kommission
https://ec.europa.eu/docsroom/documents/40323
WEBMDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software. Document date: Mon Mar 16 00:00:00 CET 2020 - Created by GROW.R.2.DIR - Publication date: n/a - Last update: Tue Mar 17 13:42:01 CET 2020.
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MDCG 2021-21 Guidance on performance evaluation of …
https://www.fdanews.com/ext/resources/files/2021/08-12-21-mdcg.pdf?1628800203
WEBThis guidance document concerns performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices (IVDs) in the context of conformity assessment under either Directive 98/79/EC or Regulation (EU) 2017/746.
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Top 30 MDCG Guidance Documents for Medical Device Companies
https://www.greenlight.guru/blog/top-mdcg-guidance
WEBMar 13, 2023 · Use this list of the top 30 MDCG guidance documents for medical device companies to find answers to some of the most-asked questions about EU MDR & IVDR. See Your ROI with Greenlight Guru in Seconds
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