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 announcement12 Jannar 2023MDCG 2023-2 - List of Standard Fees - January 2023News announcement10 Jannar 2023MDCG 2023-1 - Guidance on the health institution exception under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 - January 2023News announcement16 Diċembru 2022MDCG 2022-21 - Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 - December 2022News announcement16 Diċembru 2022MDCG 2022-4 rev.1 - Guidance on appropriate surveillance regarding MDR Art.120 transitional provisions - devices covered by MDD or AIMDD certificates - December 2022Ara 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 07Mej2021Laqgħat 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 announcement10 Jannar 2023MDCG 2023-1 - Guidance on the health institution exception under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 - January 2023
News announcement16 Diċembru 2022MDCG 2022-21 - Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 - December 2022
News announcement16 Diċembru 2022MDCG 2022-4 rev.1 - Guidance on appropriate surveillance regarding MDR Art.120 transitional provisions - devices covered by MDD or AIMDD certificates - December 2022
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
