Medical devices: UK approved bodies From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). 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 2, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Submissions received: Proposed changes to the classification of active implantable medical devices and their accessories From Therapeutic Goods Administration (TGA) 🇦🇺 Publication of submissions to the public consultation paper Proposed changes to the classification of active implantable medical devices and their accessories 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 25, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Active implantable medical devices From Spanish Agency for Medicines and Medical Devices (AEMPS) 🇪🇸 Last update: July 28, 2022 Contents Legislation Circulars Leaflets, instructions, forms Informative notes Documents of interest Fees Informative material 1. Legislation Spain Europe 2. Circulars Circular 7/04, regulation of clinical research with medical devices Circular 3/01, on clinical research… Metadata quality: Metadata quality: Data description filled Files documented 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: 77.77777777777779/100 Updated on May 27, 2024 Other (Public Domain) 0 reuses 0 favorites
Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD From European Commission 🇪🇺 Guidance on surveillance for devices covered by MDD or AIMDD certificates under Article 120 of the MDR. 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 May 27, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD From European Commission 🇪🇺 Document provides guidance on significant changes related to transitional provision under Article 120 of the MDR for devices covered by MDD or AIMDD certificates, focusing on Notified Bodies. 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
MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate - Addendum 1 From European Commission 🇪🇺 This document is an addendum to the MDCG Position Paper on the application of Article 97 MDR to legacy devices with expired certificates. 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
Medical device patient information leaflets and implant cards From Therapeutic Goods Administration (TGA) 🇦🇺 All implantable and Active Implantable Medical Devices are required to have patient information materials. 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 16, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Reclassification of Active Implantable Medical Devices (AIMD) From Therapeutic Goods Administration (TGA) 🇦🇺 This guidance is to assist sponsors comply with new regulations. Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on May 5, 2023 Other (Non-Commercial) 0 reuses 0 favorites
National regulation of medical devices From Ministry of Health (Italy) (MDS) 🇮🇹 Medical devices prior to the entry into force of Regulation (EU) 2017/745 (medical devices) and Regulation (EU) 2017/746 (in vitro diagnostic medical devices) were regulated by Directives 93/42/EEC and 90/385/EEC on medical devices and active implantable medical devices, respectively, 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 January 12, 2023 Creative Commons Attribution 3.0 0 reuses 0 favorites
MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate From European Commission 🇪🇺 This document discusses the application of Article 97 MDR to legacy devices with expired MDD or AIMDD certificates. 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
Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context From European Commission 🇪🇺 Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context. 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
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) …/… 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
Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices Text with EEA relevance From European Parliament 🇪🇺 Commission Implementing Regulation (EU) No. 920/2013 on the designation and supervision of notified bodies 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 September 24, 2013 Creative Commons Attribution 4.0 0 reuses 0 favorites
The Medical Devices (Amendment) Regulations 2013 From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 These Regulations amend the Medical Devices Regulation 2002 (the 2002 Regulations) in order to implement Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices and Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular… 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 12, 2013 Open Government Licence 3.0 (United Kingdom) 0 reuses 0 favorites
Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin Text with EEA relevance From European Parliament 🇪🇺 Commission Regulation (EU) No. 722/2012 sets specific requirements for active implantable medical devices and medical devices made from animal tissues. 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 August 8, 2012 Creative Commons Attribution 4.0 0 reuses 0 favorites
Implementation of Directive 2007/47/EC From National Organization for Medicines (EOF) 🇬🇷 Update on the revision of the legislation on medical devices (MD) and Active Implantable 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 April 7, 2010 Other (Public Domain) 0 reuses 0 favorites
Proposal for a Directive …/…/EC of the European Parliament and of the Council of […] on active implantable medical devices (Codified version) From European Parliament 🇪🇺 This document is a proposal for a directive on active implantable medical devices in the European Parliament and Council. 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 December 11, 2006 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