EU MDR Transition web publication service From Therapeutic Goods Administration (TGA) 🇦🇺 The EU MDR Transition web publication service provides notifications to providers and consumers going through low-risk changes, as part of the transition. 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 3 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
COMMISSION IMPLEMENTING REGULATION (EU) …/... amending Implementing Regulation (EU) 2022/1107 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council From European Parliament 🇪🇺 A draft implementing regulation amending specifications for class D in vitro diagnostic medical devices under EU Regulation 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 August 19, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
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
How we are managing medical device supply disruptions resulting from changes in Europe From Therapeutic Goods Administration (TGA) 🇦🇺 We are managing the impact of the European Union Medical Devices Regulation (EU MDR) transition in Australia. 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 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Commission Implementing Decision (EU) 2024/2120 of 30 July 2024 renewing the designation of issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices From European Parliament 🇪🇺 An EU implementing decision renewing the designation of entities for Unique Device Identifiers (UDIs) in medical devices field, effective from July 30, 2024. 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 30, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Announcement on Medical Devices From National Organization for Medicines (EOF) 🇬🇷 Announcement on new transitional provisions of Reg. (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IMDs) and on the ... 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 29, 2024 Other (Public Domain) 0 reuses 0 favorites
IVD - Issuance of Certificate of Free Sale (CLV) for the export of in vitro diagnostic medical devices to countries outside the European Union From Ministry of Health (Italy) (MDS) 🇮🇹 Medical devices - Online forms and services 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 July 24, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Notified Bodies in Italy for conformity assessment From Ministry of Health (Italy) (MDS) 🇮🇹 As of November 26, 2017, provisions are applicable regarding Bodies wishing to operate under Regulation (EU) 2017/745, in the medical device sector, and under Regulation (EU) 2017/746, in the in vitro diagnostic medical device sector. Notified Bodies designated under the previous Directives are no… 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 18, 2024 Creative Commons Attribution 3.0 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
Q&A on practical aspects related to the implementation of the extended transitional period provided for in the IVDR, as amended by Regulation (EU) 2024/1860 From European Commission 🇪🇺 Document covers Q&A on practical aspects of implementing extended transitional period in the IVDR, as amended by Regulation (EU) 2024/1860. 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 July 9, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 - Extension of the MDR transitional period and removal of the “sell off” periods From European Commission 🇪🇺 Q&A on implementing EU Regulation 2023/607, covering MDR transitional period extension and removal of "sell off" periods. 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 July 10, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 From European Commission 🇪🇺 Guidance on classification rules for IVD medical devices under EU Regulation 2017/746. Metadata quality: Metadata quality: Data description empty 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: 44.44444444444444/100 Updated on July 8, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Proposal for a COUNCIL DECISION on the signing, on behalf of the European Union, of the Council of Europe Framework Convention on Artificial Intelligence, Human Rights, Democracy and the Rule of Law From European Parliament 🇪🇺 A proposal for the European Union to sign the Council of Europe Framework Convention on Artificial Intelligence, focusing on human rights, democracy, and the rule of law. 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 26, 2024 Creative Commons Attribution 4.0 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
SCHEER - Call for external experts for the SCHEER WG on risks for the health associated to the use of brain stimulators not having an intended medical purpose described in the group 6 of Annex XVI to Regulation (EU) 2017/745 From European Commission 🇪🇺 Status: Open Opening date: 19 June 2024 Deadline: 31 August 2024, 23:59 (CEST) 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 June 19, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Online assessment tool and online notification form From Therapeutic Goods Administration (TGA) 🇦🇺 Use our online assessment tool and notification form to transition to the new EU MDR, so you can continue supplying 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 19, 2024 Other (Non-Commercial) 0 reuses 0 favorites
EU MDR Transition From Therapeutic Goods Administration (TGA) 🇦🇺 Overview and management of the EU European Union Medical Devices Regulation (MDR) transition under the Australian regulatory framework. 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 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Proposal for a COUNCIL DECISION on the position to be adopted, on behalf of the European Union, within the EEA Joint Committee concerning an amendment to Annex II (Technical regulations, standards, testing and certification) and Protocol 37 (containing the list provided for in Article 101) to the EEA Agreement (Reinforced role for EMA in crisis preparedness and management for medicinal products and medical devices) From European Parliament 🇪🇺 A proposal for a decision within the European Union regarding an amendment to technical regulations and protocols in the EEA Agreement for enhanced crisis management in 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 11, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Clinical investigations with medical devices From Spanish Agency for Medicines and Medical Devices (AEMPS) 🇪🇸 Updated: 30 January 2023 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (hereinafter "Regulation") sets out the general requirements in relation to clinical investigations involving medical devices in Chapter VI and the... 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 June 10, 2024 Other (Public Domain) 0 reuses 0 favorites
DM - Issuance of Certificate of Free Sale for the export of medical devices to countries outside the European Union From Ministry of Health (Italy) (MDS) 🇮🇹 Medical devices - Online forms and services 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 June 7, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites