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
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
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 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
Questions and Answers on Custom-Made Devices From European Commission 🇪🇺 Get answers to your questions about custom-made devices in this informative document. 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
Custom-made medical devices in Great Britain From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 How to comply with the regulatory requirements for manufacturing 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 December 31, 2020 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Custom-made devices From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 A document discussing considerations related to 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 December 5, 2019 Other (Public Domain) 0 reuses 0 favorites