ΕπισκόπησηΗ ΕΕ αναθεώρησε το νομικό πλαίσιο τριών οδηγιών ώστε αυτό να αντικατοπτρίζει την πρόοδο των τελευταίων 20 ετών.ΠροετοιμασίαManufacturer IVDThe procurement of MDs and IVDsAuthorised Representatives, Importers and DistributorsCompetent authorities in non-EU/EEA countriesΚατευθυντήριο έγγραφοΗ Ευρωπαϊκή Επιτροπή παρέχει σειρά εγγράφων καθοδήγησης για να βοηθήσει τα ενδιαφερόμενα μέρη στην εφαρμογή των κανονισμών για τα ιατροτεχνολογικά… Latest updatesNews announcement28 Μάρτιος 2023Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 - Extension of the MDR transitional period and removal of the “sell off” periodsNews announcement20 Μάρτιος 2023Regulation (EU) 2023/607 of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisionsNews announcement7 Μάρτιος 2023Commissioner Kyriakides welcomes Council vote on the Medical Device Regulation extensionNews announcement10 Φεβρουάριος 2023Update - MDCG 2020-16 Rev.2 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 - February 2023Δείτε τα όλα HighlightsNews announcement5 Αύγουστος 2022Call for EU reference laboratories sent to Member StatesBenchmarks for high-risk diagnosticsNews announcement21 Ιούνιος 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 Μάιος 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devicesGeneral publications10 Ιούλιος 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 Events28Μαρ2023Διασκέψεις και σύνοδοι κορυφήςDay 2: 28 March 2023 IMDRF Stakeholder Forum27Μαρ2023Διασκέψεις και σύνοδοι κορυφήςDay 1: 27 March 2023 Joint IMDRF / Stakeholder (DITTA-GMTA) Workshop07Μάιος2021Συναντήσεις εταίρωνWebinar for Patients – Safe and performant Medical Devices for all DocumentsEventsPublications
ΕπισκόπησηΗ ΕΕ αναθεώρησε το νομικό πλαίσιο τριών οδηγιών ώστε αυτό να αντικατοπτρίζει την πρόοδο των τελευταίων 20 ετών.
ΠροετοιμασίαManufacturer IVDThe procurement of MDs and IVDsAuthorised Representatives, Importers and DistributorsCompetent authorities in non-EU/EEA countries
Κατευθυντήριο έγγραφοΗ Ευρωπαϊκή Επιτροπή παρέχει σειρά εγγράφων καθοδήγησης για να βοηθήσει τα ενδιαφερόμενα μέρη στην εφαρμογή των κανονισμών για τα ιατροτεχνολογικά…
News announcement28 Μάρτιος 2023Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 - Extension of the MDR transitional period and removal of the “sell off” periods
News announcement20 Μάρτιος 2023Regulation (EU) 2023/607 of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions
News announcement7 Μάρτιος 2023Commissioner Kyriakides welcomes Council vote on the Medical Device Regulation extension
News announcement10 Φεβρουάριος 2023Update - MDCG 2020-16 Rev.2 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 - February 2023
26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EU
News announcement26 Μάιος 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices
General publications10 Ιούλιος 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
27Μαρ2023Διασκέψεις και σύνοδοι κορυφήςDay 1: 27 March 2023 Joint IMDRF / Stakeholder (DITTA-GMTA) Workshop
