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
Legacy devices From Ministry of Health (Italy) (MDS) 🇮🇹 Regulation (EU) 2017/745, for medical devices, and Regulation (EU) 2017/746, for in vitro diagnostic medical devices, allow CE-marked devices under the previous directives to remain on the market in some particular cases. 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 28, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 These Regulations make provision for the implementation in respect of Northern Ireland of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (“Regulation… 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 22, 2024 Open Government Licence 3.0 (United Kingdom) 0 reuses 0 favorites
European medical device regulations From Ministry of Health (Italy) (MDS) 🇮🇹 Medical device sector is of great importance in healthcare in Europe, contributing to the improvement of the level of health protection through the development of innovative solutions for diagnosis, prevention, treatment and rehabilitation. Since the early 2020s, due to the SARS-CoV-2 pandemic,… 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 12, 2023 Creative Commons Attribution 3.0 0 reuses 0 favorites
Corrigendum to Commission Delegated Directive (EU) 2023/1526 of 16 May 2023 amending Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead as a thermal stabilizer in polyvinyl chloride used as base material in sensors used in in vitro diagnostic medical devices (Official Journal of the European Union L 185 of 24 July 2023) From European Parliament 🇪🇺 Corrigendum to Commission Delegated Directive (EU) 2023/1526 amending Directive 2011/65/EU regarding lead exemption in 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 July 27, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
The Medical Devices (Amendment) (Great Britain) Regulations 2023 From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 These Regulations amend the Medical Devices Regulations 2002 (S.I. 2002/618) (“the 2002 Regulations”) to extend the periods for which certain medical devices that comply with EU legislation can be placed on the market in Great Britain. The 2002 Regulations were made under section 2(2) of 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 June 9, 2023 Open Government Licence 3.0 (United Kingdom) 0 reuses 0 favorites
Commission Delegated Directive (EU) 2023/1526 of 16 May 2023 amending Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead as a thermal stabilizer in polyvinyl chloride used as base material in sensors used in in vitro diagnostic medical devices (Text with EEA relevance) From European Parliament 🇪🇺 Commission Delegated Directive (EU) 2023/1526 amends Directive 2011/65/EU, exempting lead as a thermal stabilizer in PVC used in 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 16, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
COMMISSION DELEGATED DIRECTIVE (EU) .../ amending Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead as a thermal stabilizer in polyvinyl chloride used as base material in sensors used in in-vitro diagnostic medical devices From European Parliament 🇪🇺 This document is a delegated directive amending a previous directive regarding an exemption for lead in sensors used in 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 16, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Evaluation procedures for in vitro diagnostic medical devices From Ministry of Health (Italy) (MDS) 🇮🇹 As of May 26, 2022, Regulation (EU) 2017/746 (IVDR) of the European Parliament and of the Council, repealing Directive 98/79/EC and Commission Decision 2010/227/EU, is applicable with some exceptions. On September 28, 2022, Legislative Decree No. 138 of August 5, 2022 on the adaptation of national… 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 20, 2023 Creative Commons Attribution 3.0 0 reuses 0 favorites
COMMISSION DELEGATED DIRECTIVE (EU) .../… amending Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead as a thermal stabilizer in polyvinyl chloride used as base material in sensors used in in-vitro diagnostic medical devices From European Parliament 🇪🇺 This document is a draft delegated directive amending EU Directive 2011/65/EU to exempt lead as a thermal stabilizer in PVC used in 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 January 16, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
National regulation of medical devices From Ministry of Health (Italy) (MDS) 🇮🇹 Medical devices prior to the entry into force of Regulation (EU) 2017/745 (medical devices) and Regulation (EU) 2017/746 (in vitro diagnostic medical devices) were regulated by Directives 93/42/EEC and 90/385/EEC on medical devices and active implantable medical devices, respectively, 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 January 12, 2023 Creative Commons Attribution 3.0 0 reuses 0 favorites
Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on adapting non-contractual civil liability rules to artificial intelligence (AI Liability Directive) From European Parliament 🇪🇺 Proposal for a directive on adapting non-contractual civil liability rules to artificial intelligence (AI Liability Directive). 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 September 28, 2022 Creative Commons Attribution 4.0 0 reuses 0 favorites
Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC From European Commission 🇪🇺 Regulation (EU) 2017/746 applies IVDR requirements to 'legacy devices' and devices placed on the market before 26 May 2022. 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
Chapter 2 - Product Type Guidance Northern Ireland From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Submission of notifications for Northern Ireland under article 20 of directive 2014/40/EU. 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 23, 2022 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Forms in force under the Directive From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 A document outlining the forms currently valid under relevant directives. 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 November 9, 2021 Other (Public Domain) 0 reuses 0 favorites
Application of MDR requirements to "legacy devices" and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC From European Commission 🇪🇺 This document discusses the application of MDR requirements to legacy devices and devices placed on the market before May 26, 2021. 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
Commission Delegated Directive (EU) 2021/1978 of 11 August 2021 amending, for the purposes of adapting to scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for the use of bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) in spare parts recovered from and used for the repair or refurbishment of medical devices (Text with EEA relevance) From European Parliament 🇪🇺 Commission Delegated Directive (EU) 2021/1978 amends Directive 2011/65/EU regarding the use of certain phthalates in spare parts for 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 August 11, 2021 Creative Commons Attribution 4.0 0 reuses 0 favorites
COMMISSION DELEGATED DIRECTIVE (EU) .../… amending, for the purposes of adapting to scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for the use of bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) in spare parts recovered from and used for the repair or refurbishment of medical devices From European Parliament 🇪🇺 This document is a delegated directive that amends Annex IV to Directive 2011/65/EU regarding the use of certain phthalates in medical device spare parts. 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 11, 2021 Creative Commons Attribution 4.0 0 reuses 0 favorites
Notice concerning Medical Devices under Directive 93/42/EEC which contain live micro-organisms, bacteria, fungi or viruses. From National Organization for Medicines (EOF) 🇬🇷 The E.O.F. informs manufacturers, authorised dealers and distributors of products incorporating or incorporating ... 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 9, 2021 Other (Public Domain) 0 reuses 0 favorites
The Medical Devices (Northern Ireland Protocol) Regulations 2021 From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 These Regulations make provision for the implementation in respect of Northern Ireland of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 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 27, 2021 Open Government Licence 3.0 (United Kingdom) 0 reuses 0 favorites