OverviewMedical devices and In Vitro Diagnostic medical devices (IVDs) have a fundamental role in saving lives by providing innovative healthcare solutions…DirectivesThe following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively...New RegulationsThe EU revised the laws governing medical devices and in vitro diagnostics to align with the developments of the sector over the last 20 years. Latest updates News announcement17 April 2024MDCG 2024-5 - Guidance on the Investigator’s Brochure content - April 20241 min readNews announcement15 April 2024Update - MDCG 2022-9 rev.1 - Summary of safety and performance template - April 20241 min readNews announcement15 April 2024MDCG 2024-4 - Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746 - April 20241 min readNews announcement10 April 2024A Study and dashboard on reprocessing and reuse of single-use-devices in the EU1 min readSee all Highlights News announcement10 April 2024A Study and dashboard on reprocessing and reuse of single-use-devices in the EU1 min readStudy supporting the monitoring of availability of medical devices on the EU marketNews announcement21 June 2022Setting the scene for EU reference labs for high-risk diagnostics1 min read26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EUNews announcement24 May 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices1 min readThe UDI Helpdesk helps economic operators in the implementation of the requirements introduced by the new systemGetting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activitiesCommission Implementing Regulation (EU) 2020/1207 on common specifications for the reprocessing of single-use devices Events 25-26Sep2023Conferences and summitsIMDRF Meeting 24th session - 25-26 September 2023 - Berlin, Germany28Mar2023Conferences and summitsDay 2: 28 March 2023 IMDRF Stakeholder Forum27Mar2023Conferences and summitsDay 1: 27 March 2023 Joint IMDRF / Stakeholder (DITTA-GMTA) Workshop27-28Mar2023Conferences and summitsIMDRF 2023 23rd session 27-28 March 2023 - Brussels, Belgium Documents EventsPublications
OverviewMedical devices and In Vitro Diagnostic medical devices (IVDs) have a fundamental role in saving lives by providing innovative healthcare solutions…
DirectivesThe following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively...
New RegulationsThe EU revised the laws governing medical devices and in vitro diagnostics to align with the developments of the sector over the last 20 years.
News announcement17 April 2024MDCG 2024-5 - Guidance on the Investigator’s Brochure content - April 20241 min read
News announcement15 April 2024Update - MDCG 2022-9 rev.1 - Summary of safety and performance template - April 20241 min read
News announcement15 April 2024MDCG 2024-4 - Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746 - April 20241 min read
News announcement10 April 2024A Study and dashboard on reprocessing and reuse of single-use-devices in the EU1 min read
News announcement10 April 2024A Study and dashboard on reprocessing and reuse of single-use-devices in the EU1 min read
News announcement21 June 2022Setting the scene for EU reference labs for high-risk diagnostics1 min read
26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EU
News announcement24 May 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices1 min read
The UDI Helpdesk helps economic operators in the implementation of the requirements introduced by the new system
Getting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities
Commission Implementing Regulation (EU) 2020/1207 on common specifications for the reprocessing of single-use devices
25-26Sep2023Conferences and summitsIMDRF Meeting 24th session - 25-26 September 2023 - Berlin, Germany