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
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
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
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
Medical devices: new guidance for industry and notified bodies From European Medicines Agency (EMA) 🇪🇺 A document providing updated guidance for the medical device industry and notified bodies. Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on May 21, 2024 Other (Public Domain) 0 reuses 0 favorites
EUDAMED – User guides and templates From European Commission 🇪🇺 This document provides user guides and templates for EUDAMED, a system for medical device registration and monitoring in the EU. 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 April 17, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
EUDAMED – Topics per Actor From European Commission 🇪🇺 This document provides an overview of topics related to EUDAMED system categorized by different actors involved in the 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 April 17, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Focus campaigns From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 Document titled "Focus campaigns" focusing on the topic of "Market surveillance". 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 February 21, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guidance on qualification and classification of Annex XVI products - A guide for manufacturers and notified bodies From European Commission 🇪🇺 A guide for manufacturers and notified bodies on the qualification and classification of Annex XVI products. 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 14, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Guidance on demonstration of equivalence for Annex XVI products - A guide for manufacturers and notified bodies From European Commission 🇪🇺 A guide for manufacturers and notified bodies on demonstrating equivalence for Annex XVI products. 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 December 14, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Registration of notified bodies From Ministry of Health (Italy) (MDS) 🇮🇹 Medical devices - Registration of notified bodies 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 October 24, 2023 Creative Commons Attribution 3.0 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
FAQ Regulation MD - Notified bodies From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Reference document FAQ MD regulation - Notified bodies in your application process 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 February 24, 2023 Other (Non-Commercial) 0 reuses 0 favorites
What are Notified Bodies From Ministry of Health (Italy) (MDS) 🇮🇹 Medical Devices - What are Notified Bodies 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 January 12, 2023 Creative Commons Attribution 3.0 0 reuses 0 favorites
List of Standard Fees From European Commission 🇪🇺 A document titled "List of Standard Fees" that covers the topic of "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 September 6, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
MDCG position paper on "hybrid audits" From European Commission 🇪🇺 This document is a MDCG position paper on "hybrid audits" and focuses on the topic of 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
Commission Delegated Regulation (EU) 2023/503 of 1 December 2022 amending Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the frequency of complete re-assessments of notified bodies (Text with EEA relevance) From European Parliament 🇪🇺 Commission Delegated Regulation (EU) 2023/503 amends the frequency of complete re-assessments of notified bodies. 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 1, 2022 Creative Commons Attribution 4.0 0 reuses 0 favorites
Commission Delegated Regulation (EU) 2023/502 of 1 December 2022 amending Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the frequency of complete re-assessments of notified bodies (Text with EEA relevance) From European Parliament 🇪🇺 Commission Delegated Regulation (EU) 2023/502 amends Regulation (EU) 2017/745 on the frequency of re-assessments of notified bodies. 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 1, 2022 Creative Commons Attribution 4.0 0 reuses 0 favorites
Questions and answers: Requirements relating to notified bodies From European Commission 🇪🇺 This document discusses requirements for notified bodies, focusing on questions and answers. 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 September 6, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746 From European Commission 🇪🇺 This document provides clarification on the first certification for in vitro diagnostic medical devices and the procedures for notified bodies to follow. 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