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
Designation, re-assessment and notification of conformity assessment bodies and notified bodies From European Commission 🇪🇺 This document discusses the designation, re-assessment, and notification of conformity assessment bodies and 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 June 17, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 814 Premarket Approval of Medical Devices From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 814 Premarket Approval of Medical Devices". 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 March 18, 2024 Other (Public Domain) 0 reuses 0 favorites
Announcement on the Unique Designation Identification (UDI) system From National Organization for Medicines (EOF) 🇬🇷 Following our announcement dated 27-05-2021, we inform you of the current information and detailed instructions that have been ... 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, 2023 Other (Public Domain) 0 reuses 0 favorites
Assessment, designation and notification of conformity assessment bodies in France From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Reference document Assessment, designation and notification of conformity assessment bodies in France in your application process 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 October 7, 2022 Other (Non-Commercial) 0 reuses 0 favorites
Status of domestic and international test laboratory designations From Ministry of Food and Drug Safety (MFDS) 🇰🇷 This document provides an update on the designations of domestic and international test laboratories. 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 28, 2022 Other (Public Domain) 0 reuses 0 favorites
De Novo Classification Process (Evaluation of Automatic Class III Designation): Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance for the industry and FDA staff on the De Novo classification process for automatic Class III designation evaluation. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on February 18, 2022 Other (Public Domain) 0 reuses 0 favorites
Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR) From European Commission 🇪🇺 This document is about the applied-for scope of designation and notification of a conformity assessment body under Regulation (EU) 2017/746 (IVDR). 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
Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR) From European Commission 🇪🇺 This document is about the applied-for scope of designation and notification of a conformity assessment body under Regulation (EU) 2017/745 (MDR). It focuses 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
Application form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices regulation (MDR) From European Commission 🇪🇺 Application form for conformity assessment bodies seeking designation as notified bodies under the medical devices regulation (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 September 6, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices regulation (IVDR) From European Commission 🇪🇺 Application form for conformity assessment bodies seeking designation as notified bodies under the IVDR. 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
Providing Regulatory Submissions in Electronic Format Orphan-Drug and Humanitarian Use Device Designation Requests and Related Submissions: Draft Draft Guidance for Industry From Food and Drug Administration (FDA) 🇺🇸 Draft guidance document on providing regulatory submissions in electronic format for orphan-drug and humanitarian use device designation requests. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on May 13, 2021 Other (Public Domain) 0 reuses 0 favorites
Humanitarian Use Device (HUD) Designations : Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance for industry and FDA staff on Humanitarian Use Device (HUD) Designations, covering topics like Good Clinical Practice and Premarket. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on May 13, 2021 Other (Public Domain) 0 reuses 0 favorites
How to Write a Request for Designation (RFD): Guidance for Industry From Food and Drug Administration (FDA) 🇺🇸 Learn how to write a Request for Designation (RFD) with this industry guidance document focused on Combination Products. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on May 13, 2021 Other (Public Domain) 0 reuses 0 favorites
Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC to be performed in accordance with Commission Implementing Regulation (EU) 2020/666 amending Commission Implementing Regulation (EU) 920/2013 From European Commission 🇪🇺 This document provides guidance on the renewal and monitoring of notified bodies under EU Directives 90/385/EEC and 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 September 6, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
How to Prepare a Pre-Request for Designation (Pre-RFD): Guidance for Industry From Food and Drug Administration (FDA) 🇺🇸 Learn how to prepare a Pre-Request for Designation (Pre-RFD) with this industry guidance document on Combination Products. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on January 21, 2020 Other (Public Domain) 0 reuses 0 favorites
Commission Implementing Decision (EU) 2019/1396 of 10 September 2019 laying down the rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the designation of expert panels in the field of medical devices (Text with EEA relevance.) From European Parliament 🇪🇺 Commission Implementing Decision (EU) 2019/1396 lays down rules for the application of Regulation (EU) 2017/745 on expert panels 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 10, 2019 Creative Commons Attribution 4.0 0 reuses 0 favorites
COMMISSION IMPLEMENTING REGULATION (EU) …/... on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council From European Parliament 🇪🇺 This document is an implementing regulation that specifies the codes and types of devices for the designation of notified bodies in the field 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 November 23, 2017 Creative Commons Attribution 4.0 0 reuses 0 favorites
Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council (Text with EEA relevance. ) From European Parliament 🇪🇺 Commission Implementing Regulation specifying the scope of designation as notified bodies for medical devices and in vitro diagnostic 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 November 23, 2017 Creative Commons Attribution 4.0 0 reuses 0 favorites
Guide to Notified Bodies Designation Process From Health Products Regulatory Authority (HPRA) 🇮🇪 A document providing guidance on the process of designating Notified Bodies. 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 November 20, 2017 Other (Public Domain) 0 reuses 0 favorites