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
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
Application for certificates for free sale (MDD medical devices system and procedure packs legacy devices) From Health Products Regulatory Authority (HPRA) 🇮🇪 A form for applying for certificates for free sale related to MDD medical devices system and procedure packs legacy devices. 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, 2021 Other (Public Domain) 0 reuses 0 favorites
MDR Newsletter 2/2020: How long devices covered by the MDD can be marketed From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 A newsletter discussing the duration for which devices covered by the Medical Device Directive (MDD) can be marketed, published in 2020. 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 17, 2021 Other (Public Domain) 0 reuses 0 favorites
Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses From Food and Drug Administration (FDA) 🇺🇸 Document number 2018-27809. The Food and Drug Administration (FDA) is issuing a final order to reclassify the electroconvulsive therapy (ECT) device for use in treating catatonia or a severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in… 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 26, 2018 Other (Public Domain) 0 reuses 0 favorites
Neurological Devices; Reclassification of Electroconvulsive Therapy Devices Intended for Use in Treating Severe Major Depressive Episode in Patients 18 Years of Age and Older Who Are Treatment Resistant or Require a Rapid Response; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy for Certain Specified Intended Uses From Food and Drug Administration (FDA) 🇺🇸 Document number 2015-32592. The Food and Drug Administration (FDA) is issuing a proposed administrative order to reclassify the electroconvulsive therapy (ECT) device for use in treating severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD)… 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 29, 2015 Other (Public Domain) 0 reuses 0 favorites
Proposal for a Directive of the European Parliament and of the Council amending Council Directives 90/385/EEC and 93/42/EEC and Directive 98/8/EC of the European Parliament and the Council as regards the review of the medical device directives {SEC(2005)1742} From European Parliament 🇪🇺 This document is a proposal to amend medical device directives in the European Parliament and Council, aiming to review and update existing regulations. 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 22, 2005 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 Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995 From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 These Regulations (“the Regulations”) amend the Active Implantable Medical Devices Regulations 1992 (“the principal Regulations”) which implement Council Directive 90/385/EEC (OJ No. L 189, 20.7.90, p. 17) (“the active implantable medical devices Directive”). The Regulations implement those… 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 30, 1995 Open Government Licence 3.0 (United Kingdom) 0 reuses 0 favorites
Form: Sponsor notification for medical devices transitioning from the EU MDD to the EU MDR From Therapeutic Goods Administration (TGA) 🇦🇺 Closes 31 Jul 2029 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 November 6, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Tool: Sponsor obligations for medical devices transitioning from the EU MDD to the EU MDR From Therapeutic Goods Administration (TGA) 🇦🇺 Closes 31 Jul 2029 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 September 6, 2023 Other (Non-Commercial) 0 reuses 0 favorites