Commission Implementing Decision (EU) 2024/817 of 6 March 2024 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for sterilisation of health care products and packaging for terminally sterilised medical devices From European Parliament 🇪🇺 The document is an EU Implementing Decision from 2024 amending standards for sterilization of healthcare products and packaging for medical devices. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 6, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Commission Implementing Decision (EU) 2024/815 of 6 March 2024 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for medical gloves for single use, biological evaluation of medical devices, sterilization of health care products, packaging for terminally sterilized medical devices and processing of health care products From European Parliament 🇪🇺 The document is a Commission Implementing Decision amending standards for medical gloves, biological evaluation of devices, sterilization, packaging, and processing of healthcare products. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 6, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Commission Implementing Decision (EU) 2023/1410 of 4 July 2023 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for sterilization of health care products and biological evaluation of medical devices From European Parliament 🇪🇺 Commission Implementing Decision (EU) 2023/1410 amends harmonised standards for sterilization of healthcare products and biological evaluation of medical devices. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on July 4, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
MDR Newsletter 1/2022: MDR and IVDR harmonised standards From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 A newsletter discussing harmonised standards for Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) in the 1/2022 edition. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 29, 2023 Other (Public Domain) 0 reuses 0 favorites
MDR/IVDR Newsletter 8/2022: MDR and IVDR harmonised standards II. From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 A newsletter discussing harmonised standards for Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) in the 8/2022 edition. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 29, 2023 Other (Public Domain) 0 reuses 0 favorites
Commission Implementing Decision (EU) 2022/757 of 11 May 2022 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for quality management systems, sterilisation and application of risk management to medical devices From European Parliament 🇪🇺 Commission Implementing Decision (EU) 2022/757 amends Implementing Decision (EU) 2021/1182 on harmonised standards for quality management systems and risk management in medical devices. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on May 11, 2022 Creative Commons Attribution 4.0 0 reuses 0 favorites
Commission Implementing Decision (EU) 2022/729 of 11 May 2022 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for quality management systems and for application of risk management to medical devices From European Parliament 🇪🇺 Commission Implementing Decision (EU) 2022/729 amends EU Implementing Decision (EU) 2021/1195 on harmonised standards for quality management systems and risk management in medical devices. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on May 11, 2022 Creative Commons Attribution 4.0 0 reuses 0 favorites
Commission Implementing Decision (EU) 2022/6 of 4 January 2022 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for biological evaluation of medical devices, sterilisation of health care products, aseptic processing of health care products, quality management systems, symbols to be used with information to be supplied by the manufacturer, processing of health care products and home light therapy equipment From European Parliament 🇪🇺 Commission Implementing Decision (EU) 2022/6 amends EU standards for medical devices, sterilization, quality management, and more. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on January 4, 2022 Creative Commons Attribution 4.0 0 reuses 0 favorites
Commission Implementing Decision (EU) 2021/1195 of 19 July 2021 on the harmonised standards for in vitro diagnostic medical devices drafted in support of Regulation (EU) 2017/746 of the European Parliament and of the Council From European Parliament 🇪🇺 Commission Implementing Decision (EU) 2021/1195 harmonizes standards for in vitro diagnostic medical devices, supporting Regulation (EU) 2017/746. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on July 19, 2021 Creative Commons Attribution 4.0 0 reuses 0 favorites
Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council From European Parliament 🇪🇺 Commission Implementing Decision (EU) 2021/1182 harmonizes standards for medical devices in support of Regulation (EU) 2017/745. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on July 16, 2021 Creative Commons Attribution 4.0 0 reuses 0 favorites
Commission Implementing Decision (EU) 2021/611 of 14 April 2021 amending Implementing Decision (EU) 2020/438 as regards harmonised standards on biological evaluation of medical devices, packaging for terminally sterilised medical devices, sterilisation of health care products and clinical investigation of medical devices for human subjects From European Parliament 🇪🇺 Commission Implementing Decision (EU) 2021/611 amends Implementing Decision (EU) 2020/438 on harmonised standards for medical devices and clinical investigations. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on April 14, 2021 Creative Commons Attribution 4.0 0 reuses 0 favorites
Commission Implementing Decision (EU) 2021/610 of 14 April 2021 amending Implementing Decision (EU) 2020/437 as regards harmonised standards on medical vehicles and their equipment, anaesthetic and respiratory equipment, biological evaluation of medical devices, packaging for terminally sterilised medical devices, sterilisation of health care products, clinical investigation of medical devices for human subjects, non-active surgical implants, medical devices utilising animal tissues and their derivatives, electroacoustics and medical electrical equipment From European Parliament 🇪🇺 Amendment to Implementing Decision (EU) 2020/437 on harmonised standards for medical vehicles, equipment, and devices. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on April 14, 2021 Creative Commons Attribution 4.0 0 reuses 0 favorites
Commission Implementing Decision (EU) 2021/609 of 14 April 2021 amending Implementing Decision (EU) 2020/439 as regards harmonised standards on packaging for terminally sterilised medical devices and sterilisation of health care products From European Parliament 🇪🇺 Commission Implementing Decision (EU) 2021/609 amends standards on packaging for sterilised medical devices and sterilisation of healthcare products. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on April 14, 2021 Creative Commons Attribution 4.0 0 reuses 0 favorites
Commission Implementing Decision (EU) 2020/439 of 24 March 2020 on the harmonised standards for in vitro diagnostic medical devices drafted in support of Directive 98/79/EC of the European Parliament and of the Council From European Parliament 🇪🇺 Commission Implementing Decision (EU) 2020/439 harmonizes standards for in vitro diagnostic medical devices, supporting Directive 98/79/EC. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 24, 2020 Creative Commons Attribution 4.0 0 reuses 0 favorites
Commission Implementing Decision (EU) 2020/438 of 24 March 2020 on the harmonised standards for active implantable medical devices drafted in support of Council Directive 90/385/EEC From European Parliament 🇪🇺 Commission Implementing Decision (EU) 2020/438 on harmonised standards for active implantable medical devices under Council Directive 90/385/EEC. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 24, 2020 Creative Commons Attribution 4.0 0 reuses 0 favorites
Commission Implementing Decision (EU) 2020/437 of 24 March 2020 on the harmonised standards for medical devices drafted in support of Council Directive 93/42/EEC From European Parliament 🇪🇺 Commission Implementing Decision (EU) 2020/437 harmonises standards for medical devices in support of Council Directive 93/42/EEC. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 24, 2020 Creative Commons Attribution 4.0 0 reuses 0 favorites
COMMISSION IMPLEMENTING DECISION (EU) …/… on the harmonised standards for medical devices drafted in support of Council Directive 93/42/EEC From European Parliament 🇪🇺 This document is an implementing decision on harmonised standards for medical devices in support of Council Directive 93/42/EEC. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on March 24, 2020 Creative Commons Attribution 4.0 0 reuses 0 favorites
COMMISSION IMPLEMENTING DECISION (EU) …/… on the harmonised standards for active implantable medical devices drafted in support of Council Directive 90/385/EEC From European Parliament 🇪🇺 This document is an implementing decision on harmonised standards for active implantable medical devices under Council Directive 90/385/EEC. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on March 24, 2020 Creative Commons Attribution 4.0 0 reuses 0 favorites