Ħarsa ġeneraliL-UE rrevediet il-qafas legali tat-3 direttivi attwali biex tirrifletti l-progress matul l-aħħar 20 sena.Inħejju ruħnaManufacturer IVDManufacturers MDManufacturers of devices without an intended medical purposeHealthcare professionals and health institutionsThe procurement of MDs and IVDsAuthorised Representatives, Importers and DistributorsCompetent authorities in non-EU/EEA countriesGwidaIl-Kummissjoni Ewropea tipprovdi firxa ta’ dokumenti ta’ gwida biex jassistu lill-partijiet ikkonċernati fl-implimentazzjoni tar-regolamenti dwar l… Latest updatesNews announcement30 Novembru 2022Updated information pack for candidate EU reference laboratories publishedNews announcement5 Awwissu 2022Call for EU reference laboratories sent to Member StatesNews announcement5 Lulju 2022Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications in accordance with Regulation (EU) 2017/746News announcement21 Ġunju 2022Setting the scene for EU reference labs for high-risk diagnosticsAra 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 Events07Mej2021Laqgħat tal-imsieħbaWebinar for Patients – Safe and performant Medical Devices for all DocumentsEventsPublications
Ħarsa ġeneraliL-UE rrevediet il-qafas legali tat-3 direttivi attwali biex tirrifletti l-progress matul l-aħħar 20 sena.
Inħejju ruħnaManufacturer IVDManufacturers MDManufacturers of devices without an intended medical purposeHealthcare professionals and health institutionsThe procurement of MDs and IVDsAuthorised Representatives, Importers and DistributorsCompetent authorities in non-EU/EEA countries
GwidaIl-Kummissjoni Ewropea tipprovdi firxa ta’ dokumenti ta’ gwida biex jassistu lill-partijiet ikkonċernati fl-implimentazzjoni tar-regolamenti dwar l…
News announcement30 Novembru 2022Updated information pack for candidate EU reference laboratories published
News announcement5 Lulju 2022Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications in accordance with Regulation (EU) 2017/746
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
