Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices From European Commission 🇪🇺 Document discusses the regulatory status of ethylene oxide (EtO) for sterilizing medical devices, focusing on Borderline and Classification topics. 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 2 weeks ago Creative Commons Attribution 4.0 0 reuses 0 favorites
Borderline products From Ministry of Health (Italy) (MDS) 🇮🇹 Medical Devices - Borderline Products 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 19, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Borderlines with medical devices and other products in Great Britain From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Guidance on whether or not your product is a medical device. 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 8, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Borderline products: how to tell if your product is a medicine From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 How the MHRA makes decisions on what is a medicinal product (borderline products). 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 8, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Manual on Borderline From European Commission 🇪🇺 A manual on Borderline, covering topics related to Borderline and Classification. 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 March 13, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Borderline products: how to tell if your product is a medical device and which risk class applies From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 How the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device. 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 11, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices From European Commission 🇪🇺 Guidance on determining the distinction between medical devices and medicinal products under EU Regulation 2017/745. 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
Guidance on classification of medical devices From European Commission 🇪🇺 A document providing guidance on classifying medical devices, focusing on borderline cases and classification criteria. 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
Helsinki Procedure for borderline and classification under MDR & IVDR From European Commission 🇪🇺 Learn about the Helsinki Procedure for borderline and classification under MDR & IVDR. 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
Regulation of borderline disinfectant and related products with antiviral claims including COVID-19 From Therapeutic Goods Administration (TGA) 🇦🇺 Information to assist sponsors and manufacturers of products making antiviral claims determine if their products requires an entry in the Australian Register of Therapeutic Goods (ARTG) to be legally imported and/or supplied in Australia. 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 August 2, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Borderlines between medical devices and medicinal products From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 How to distinguish between products that are regulated as medical devices and those regulated as medicinal 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 31, 2020 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
