Medical devices From European Medicines Agency (EMA) 🇪🇺 Medical devices are regulated at EU Member State level, but the European Medicines Agency (EMA) is involved in the regulatory process. Metadata quality: Metadata quality: Data description filled Files documented 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: 66.66666666666666/100 Updated on May 21, 2024 Other (Public Domain) 0 reuses 0 favorites
Custom-made devices and Regulation (EU) 2017/745 From Ministry of Health (Italy) (MDS) 🇮🇹 As of May 26, 2021, the Regulation (EU) 2017/745, which entered into force on May 25, 2017, applies to custom-made medical devices in a harmonized manner in all member states. The Legislative Decree of August 5, 2022, No. 137 adapts national legislation to the provisions of the regulation and… 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 12, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
COMMISSION IMPLEMENTING REGULATION (EU) …/... laying down, pursuant to Regulation (EU) 2021/2282 of the European Parliament and of the Council, detailed procedural rules for the cooperation of the Member State Coordination Group on Health Technology Assessment and the Commission with the European Medicines Agency in the form of exchange of information as regards the joint clinical assessment of medicinal products and medical devices and in vitro diagnostic medical devices and as regards the joint scientific consultation on medicinal products and medical devices From European Parliament 🇪🇺 A draft implementing regulation detailing procedural rules for cooperation among Member State Coordination Group, Commission, and European Medicines Agency on joint clinical assessments and scientific consultations for medicinal products and 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 June 26, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
National register of breast prosthetic implants From Ministry of Health (Italy) (MDS) 🇮🇹 Breast implants , commonly implanted for cosmetic or reconstructive reasons, are class III medical devices, the highest risk class, regulated by Legislative Decree No. 137 of August 5, 2022 and EU Regulation 745/2017 . The Ministry of Health, as the Competent Authority on medical devices in Italy,… 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 June 5, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Health Technology Assessment in Europe From Ministry of Health (Italy) (MDS) 🇮🇹 Health technology assessment (HTA) has long been recognized as an important part of decision-making processes in most EU countries. Regulation (EU) 2021/2282 defined the modalities of cooperation among EU member states in health technology assessment, building on the voluntary collaboration… 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 13, 2023 Creative Commons Attribution 3.0 0 reuses 0 favorites
MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States From European Commission 🇪🇺 This document is about the use of the EUDAMED actor registration module and the Single Registration Number (SRN) in Member States. 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 September 6, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
The Medical Devices Regulations 2002 From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 These Regulations contain the legislative measures necessary for the implementation of three European Community Directives: Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, as amended; 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 June 13, 2002 Open Government Licence 3.0 (United Kingdom) 0 reuses 0 favorites
The Medical Devices Fees (Amendment) Regulations 1997 From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 These Regulations amend the Medical Devices Fees Regulations 1995 (“the principal Regulations”). The principal Regulations prescribe the fees payable in connection with the services provided by the Department of Health pursuant to the Secretary of State’s functions under Council Directives… 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 10, 1997 Open Government Licence 3.0 (United Kingdom) 0 reuses 0 favorites
The Medical Devices Fees Regulations 1995 From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 These Regulations (“the Regulations”) prescribe the fees payable in connection with the services provided by the Department of Health in pursuance of the Secretary of State’s functions under Council Directives 90/385/EEC on the approximation of the laws of member States relating to active… 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 September 20, 1995 Open Government Licence 3.0 (United Kingdom) 0 reuses 0 favorites
The Active Implantable Medical Devices Regulations 1992 From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 These Regulations (“the Regulations”) implement Council Directive 90/385/EEC (“Directive”) on the approximation of the laws of the Member States relating to active implantable medical devices (OJ No. L189, 20.7.90, p. 17). 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 December 10, 1992 Open Government Licence 3.0 (United Kingdom) 0 reuses 0 favorites
RE-EXAMINED PROPOSAL FOR A COUNCIL DIRECTIVE ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ACTIVE IMPLANTABLE MEDICAL DEVICES From European Parliament 🇪🇺 Amended proposal for a directive on active implantable medical devices, aiming to harmonize laws across member states. 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 June 14, 1990 Creative Commons Attribution 4.0 0 reuses 0 favorites