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
NOR registration for custom-made device manufacturers From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 A guide outlining the registration process for manufacturers of custom-made medical devices in the NOR. 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 24, 2024 Other (Public Domain) 0 reuses 0 favorites
List of persons responsible for custom-made medical devices marketing From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Reference document List of persons responsible for custom-made medical devices marketing 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 June 5, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Custom-made medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 Information for manufacturers, sponsors and health professionals on the definition of a custom-made medical device and how we regulate them. 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 31, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Personalised medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 Links to information on personalised medical devices (including custom-made, patient-matched, and adaptable 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 May 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Notice on Custom-made technology products From National Organization for Medicines (EOF) 🇬🇷 To see the announcement click 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 April 23, 2024 Other (Public Domain) 0 reuses 0 favorites
Registration on the list of custom-made medical device manufacturers From Ministry of Health (Italy) (MDS) 🇮🇹 Manufacturers who make bespoke medical devices available on the national territory notify the Ministry of Health of their identification data and the list of bespoke medical devices (Article 7, paragraph 1 of Legislative Decree 137/2022), through the online service accessible from the portal… 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 18, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Directory of custom-made medical device manufacturers From Ministry of Health (Italy) (MDS) 🇮🇹 Medical devices - Directory of custom-made medical device manufacturers 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 March 6, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Unique device identification system From Ministry of Health (Italy) (MDS) 🇮🇹 The unique device identification system ("UDI system") provided for in the Medical Devices Regulation (EU) 2017/745 and the In Vitro Diagnostic Devices (IVD) Regulation (EU) 2017/746 allows for the identification and facilitates the traceability of devices. The system involves: assigning a basic… 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 February 12, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
How to submit a custom-made medical device and patient-matched medical device notification From Therapeutic Goods Administration (TGA) 🇦🇺 This guide will assist you with completing and submitting a Custom-Made Medical Device (CMMD) notification and Patient-Matched Medical Device (PMMD) transition notification. 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 17, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Notification of medical devices From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 Notification of medical devices for market access. 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
Obligations of manufacturers of custom-made devices according to the MDR From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 This document outlines the responsibilities of manufacturers of custom-made devices in compliance with the Medical Device Regulation (MDR). 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 2, 2023 Other (Public Domain) 0 reuses 0 favorites
MDCG 2021-3 - Questions and answers on custom-made devices and considerations for adaptable medical devices and patient matched medical devices From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 A document providing guidance on custom-made devices, adaptable medical devices, and patient-matched medical devices, addressing common questions and considerations. 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 2, 2023 Other (Public Domain) 0 reuses 0 favorites
Custom-made implantable Class III devices From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 The document discusses the development and use of custom-made implantable Class III medical devices. 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 2, 2023 Other (Public Domain) 0 reuses 0 favorites
Custom-made devices guide/concepts - Frequently Asked Questions (FAQ) From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 A document providing answers to common queries about custom-made medical devices. 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 2, 2023 Other (Public Domain) 0 reuses 0 favorites
MDR Newsletter 16/2021: Frequently Asked Questions and Technical Information Part II (Registration - manufacturers and custom-made device manufacturers) From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 A newsletter (MDR Newsletter 16/2021) covering FAQs and technical details on registration for manufacturers and custom-made device manufacturers. 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 2, 2022 Other (Public Domain) 0 reuses 0 favorites
MDR Newsletter 12/2021: Information for custom-made device manufacturers From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 A newsletter for custom-made device manufacturers, providing information for December 2021. 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 March 2, 2022 Other (Public Domain) 0 reuses 0 favorites
Therapeutic Goods (Custom-Made Medical Devices-Annual Reporting Form) Approval 2021 From Therapeutic Goods Administration (TGA) 🇦🇺 Therapeutic Goods (Custom-Made Medical Devices-Annual Reporting Form) Approval 2021 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 20, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Notice on Custom-made technology products From National Organization for Medicines (EOF) 🇬🇷 "Custom-made technological product" means any medical device manufactured specifically according to a medical prescription ... 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 9, 2021 Other (Public Domain) 0 reuses 0 favorites
Custom-made medical devices From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Reference document Custom-made medical devices 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 May 25, 2021 Other (Non-Commercial) 0 reuses 0 favorites