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) ðŸ‡ðŸ‡º 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
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
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
Custom-made devices guide/concepts - Frequently Asked Questions (FAQ) From National Institute of Pharmacy and Nutrition (OGYÉI) ðŸ‡ðŸ‡º 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
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
COMMUNICATION CONCERNING CUSTOM-MADE MEDICAL DEVICES 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 March 17, 2021 Other (Public Domain) 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) ðŸ‡ðŸ‡º 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
Guidance for Health Care Professionals on Special Access and Custom-Made Medical Devices From Health Canada 🇨🇦 Guidance for Health Care Professionals on Special Access and 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 February 18, 2016 Open Government License 2.0 (Canada) 0 reuses 0 favorites
List of Custom-made Medical Devices_August 2014 From Health Sciences Authority (HSA) 🇸🇬 Guidance document from August 2014 listing custom-made medical devices, focusing on regulations and specifications for such devices. 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 August 1, 2014 Other (Public Domain) 0 reuses 0 favorites
Royal Decree 437/2002 of May 10 From Ministry of Health (Spain) (MISAN) 🇪🇸 Royal Decree 437/2002, of May 10, 2002, establishing the criteria for the granting of operating licenses to manufacturers of custom-made 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 March 12, 2024 Other (Public Domain) 0 reuses 0 favorites