Declare the discontinuation of a medical device or in vitro diagnostic medical device From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Procedure Declare a medical device or in vitro diagnostic medical device discontinued or no longer marketed 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 2 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
COMMISSION IMPLEMENTING REGULATION (EU) …/... amending Implementing Regulation (EU) 2022/1107 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council From European Parliament 🇪🇺 A draft implementing regulation amending specifications for class D in vitro diagnostic medical devices under EU Regulation 2017/746. 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 19, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
How to declare if you are a manufacturer or distributor of in vitro diagnostic medical devices From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Reference document How to declare if you are a manufacturer or distributor of in vitro diagnostic medical devices 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 August 19, 2024 Other (Non-Commercial) 0 reuses 0 favorites
In vitro diagnostic medical devices From Spanish Agency for Medicines and Medical Devices (AEMPS) 🇪🇸 Last update: August 14, 2024 EC survey active until October 11: The European Commission (EC) is considering extending the use of electronic instructions for all medical devices for professional use (currently, only some medical devices are allowed to be used... Metadata quality: Metadata quality: Data description filled Files documented 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: 77.77777777777779/100 Updated on August 14, 2024 Other (Public Domain) 0 reuses 0 favorites
In vitro diagnostic medical devices - Requesting authorization for a performance study From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Procedure In vitro diagnostic medical devices - Requesting authorization for a performance study 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 August 7, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Medical device conformity assessment application From Therapeutic Goods Administration (TGA) 🇦🇺 Information and forms about applications for TGA conformity assessment certificates. 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 August 6, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Varying entries in the ARTG: medical devices and IVDs From Therapeutic Goods Administration (TGA) 🇦🇺 This guidance is for sponsors applying for a variation to the Australian Register of Therapeutic Goods (ARTG) entry of a medical device or IVD 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 August 6, 2024 Other (Non-Commercial) 0 reuses 0 favorites
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
Announcement on Medical Devices From National Organization for Medicines (EOF) 🇬🇷 Announcement on new transitional provisions of Reg. (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IMDs) and on the ... 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 29, 2024 Other (Public Domain) 0 reuses 0 favorites
Market control of in vitro diagnostic medical devices From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Reference document Controlling the market for in vitro diagnostic medical devices your approach 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 29, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Regulations governing medical devices (MD) and in vitro diagnostic medical devices (IVDMD) From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Reference document Regulations governing medical devices (MD) and in vitro diagnostic medical devices (IVDMD) 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 July 24, 2024 Other (Non-Commercial) 0 reuses 0 favorites
IVD - Issuance of Certificate of Free Sale (CLV) for the export of in vitro diagnostic medical devices to countries outside the European Union From Ministry of Health (Italy) (MDS) 🇮🇹 Medical devices - Online forms and services 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 24, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Market surveillance of medical devices (MD) and in vitro diagnostic medical devices (IVDD) From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Reference document Market surveillance of medical devices (MD) and in vitro diagnostic medical devices (IVDD) of your approach 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 Other (Non-Commercial) 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
Manufacturing medical devices and IVDs From Therapeutic Goods Administration (TGA) 🇦🇺 This section is for manufacturers of medical devices and IVDs. 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 8, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Classification of medical devices that are not IVDs From Therapeutic Goods Administration (TGA) 🇦🇺 Guidance to assist medical devices manufacturers in correctly classifying their 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 July 2, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Classification of medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 How medical devices are classified, including in vitro diagnostics (IVDs). 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 2, 2024 Other (Non-Commercial) 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
Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 From European Commission 🇪🇺 Guidance on classification rules for IVD medical devices under EU Regulation 2017/746. 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 July 8, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
IVD sponsors: a roadmap to market From Therapeutic Goods Administration (TGA) 🇦🇺 This road map is intended for Australian sponsors of IVDs and presents an overview of the requirements for supplying an IVD under the new regulatory framework. 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 26, 2024 Other (Non-Commercial) 0 reuses 0 favorites