Ħarsa ġeneraliL-Apparati mediċi u l-Apparati Mediċi Dijanjostiċi In Vitro (IVDs) għandhom rwol fundamentali fis-salvataġġ tal-ħajjiet billi jipprovdu…DirettiviId-Direttivi dwar l-apparati mediċi li ġejjin huma bħalissa applikabbli fl-UE 1998: Direttiva 98/79/KE tal-Parlament Ewropew u tal-Kunsill…Regolamenti ġoddaL-UE rrevediet il-liġijiet li jirregolaw l-apparati mediċi u d-dijanjostika in vitro biex tallinja mal-iżviluppi tas-settur matul l-aħħar 20 sena. Latest updates 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 MDRNews announcement31 Awwissu 2023MDR and IVDR Communication SurveyNews announcement23 Awwissu 2023Flowchart to assist in deciding whether or not a device is covered by the extended MDR transitional periodAra kollox Highlights News 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 announcement24 Mejju 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devicesNews announcement26 Mejju 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devicesThe 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 activities Events 25-26Set2023Konferenzi 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 Documents EventsPublications
Ħarsa ġeneraliL-Apparati mediċi u l-Apparati Mediċi Dijanjostiċi In Vitro (IVDs) għandhom rwol fundamentali fis-salvataġġ tal-ħajjiet billi jipprovdu…
DirettiviId-Direttivi dwar l-apparati mediċi li ġejjin huma bħalissa applikabbli fl-UE 1998: Direttiva 98/79/KE tal-Parlament Ewropew u tal-Kunsill…
Regolamenti ġoddaL-UE rrevediet il-liġijiet li jirregolaw l-apparati mediċi u d-dijanjostika in vitro biex tallinja mal-iżviluppi tas-settur matul l-aħħar 20 sena.
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 announcement23 Awwissu 2023Flowchart to assist in deciding whether or not a device is covered by the extended MDR transitional period
26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EU
News announcement24 Mejju 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices
News announcement26 Mejju 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices
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
