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. Il-... Latest updates News announcement14 Settembru 2022MDCG 2021-22 rev.1 - Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies (September 2022)News announcement14 Settembru 2022MDCG 2022-15 - Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR (September 2022)News announcement10 Awwissu 2022MDCG 2022-13 - Designation, re-assessment and notification of conformity assessment bodies and notified bodiesNews announcement5 Awwissu 2022Call for EU reference laboratories sent to Member StatesAra 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 07Mej2021 Laqgħat tal-imsieħba Webinar 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. Il-...
News announcement14 Settembru 2022MDCG 2021-22 rev.1 - Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies (September 2022)
News announcement14 Settembru 2022MDCG 2022-15 - Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR (September 2022)
News announcement10 Awwissu 2022MDCG 2022-13 - Designation, re-assessment and notification of conformity assessment bodies and notified bodies
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
