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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 repeals Directive 93/42/EEC on medical devices and the Directive 90/385/EEC on active …
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 …
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- The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively...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 …
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 medical …
The European Union Medical Device Regulation – …
- https://eumdr.com/
- Publication of MDCG 2021-24 Guidance on classification of medical devices. The EUDAMED UDI/Devices and NBs & Certificates modules are now open for economic …
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 …
Guidelines on phthalates in medical devices - Public Health
- https://health.ec.europa.eu/other-pages/health-sc-basic-page/guidelines-phthalates-medical-devices_en
- Following a request from the European Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) provided the final version of the …
MEDICAL DEVICES : Guidance document
- https://ec.europa.eu/docsroom/documents/10283/attachments/1/translations/en/renditions/pdf
- device for the delivery of liquid to the human body (e.g. medicine spoons, cups,droppers, without graduation or scale or display of measuring unit), device for displaying trends of …
MEDICAL DEVICES : Guidance document
- https://ec.europa.eu/docsroom/documents/10288/attachments/1/translations/en/renditions/pdf
- The medical devices directives (MDD, AIMD, [draft IVD]) each require a statementgiven on the label and/or the information provided with the device on any time limitationon the safe …
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