Ħarsa ġeneraliL-UE rrevediet il-qafas legali ta’ 3 direttivi biex tirrifletti l-progress matul l-aħħar 20 sena.Inħejju ruħnaManufacturer IVDAuthorised Representatives, Importers and DistributorsGwidaIl-Kummissjoni Ewropea tipprovdi firxa ta’ dokumenti ta’ gwida biex jassistu lill-partijiet ikkonċernati fl-implimentazzjoni tar-regolamenti dwar l… Latest updatesNews announcement27 Settembru 2023Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (September 2023)News announcement26 Settembru 2023Q&A on transitional provisions for products without an intended medical purpose covered by annex XVI of the MDRNews announcement31 Awwissu 2023MDR and IVDR Communication SurveyNews announcement17 Lulju 2023Updated - Factsheet for authorities in non-EU/EEA states on medical devices and in vitro diagnostic medical devicesAra kollox HighlightsNews announcement5 Awwissu 2022Call for EU reference laboratories sent to Member StatesBenchmarks for high-risk diagnosticsNews announcement21 Ġunju 2022Setting the scene for EU reference labs for high-risk diagnostics26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EUNews announcement26 Mejju 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devicesGeneral publications10 Lulju 2020State of play of Joint implementation Plan on actions considered necessary to ensure the sound functioning of the new framework for medical devices under the MDRThe UDI Helpdesk is live. It helps the economic operators in the implementation of the requirements introduced by the new UDI systemGetting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities Events25-26Set2023Konferenzi u summitsIMDRF Meeting 24th session - 25-26 September 2023 - Berlin, Germany28Mar2023Konferenzi u summitsDay 2: 28 March 2023 IMDRF Stakeholder Forum27Mar2023Konferenzi u summitsDay 1: 27 March 2023 Joint IMDRF / Stakeholder (DITTA-GMTA) Workshop07Mej2021Laqgħat tal-imsieħbaWebinar for Patients – Safe and performant Medical Devices for all DocumentsEventsPublications
Ħarsa ġeneraliL-UE rrevediet il-qafas legali ta’ 3 direttivi biex tirrifletti l-progress matul l-aħħar 20 sena.
GwidaIl-Kummissjoni Ewropea tipprovdi firxa ta’ dokumenti ta’ gwida biex jassistu lill-partijiet ikkonċernati fl-implimentazzjoni tar-regolamenti dwar l…
News announcement27 Settembru 2023Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (September 2023)
News announcement26 Settembru 2023Q&A on transitional provisions for products without an intended medical purpose covered by annex XVI of the MDR
News announcement17 Lulju 2023Updated - Factsheet for authorities in non-EU/EEA states on medical devices and in vitro diagnostic medical devices
26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EU
News announcement26 Mejju 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices
General publications10 Lulju 2020State of play of Joint implementation Plan on actions considered necessary to ensure the sound functioning of the new framework for medical devices under the MDR
The UDI Helpdesk is live. It helps the economic operators in the implementation of the requirements introduced by the new UDI system
Getting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities
