Επισκόπηση Ο ρόλος των ιατροτεχνολογικών προϊόντων και των in vitro διαγνωστικών ιατροτεχνολογικών προϊόντων μπορεί να είναι καίριος για τη διάσωση ζωών, αφού… Ισχύουσες οδηγίες Οι ακόλουθες οδηγίες για τα ιατροτεχνολογικά προϊόντα εφαρμόζονται επί του παρόντος εντός της ΕΕ1998: Οδηγία 98/79/ΕΚ του Ευρωπαϊκού Κοινοβουλίου και… νέοι κανονισμοί Η ΕΕ αναθεώρησε τη νομοθεσία που διέπει τα ιατροτεχνολογικά προϊόντα και τα in-vitro διαγνωστικά ιατροτεχνολογικά προϊόντα για να την ευθυγραμμίσει με τις εξελίξεις στον τομέα κατά τα τελευταία 20 έτη. Οι... Latest updates News announcement13 Ιούλιος 2022MDCG 2022-12 - Harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for IVDR)News announcement5 Ιούλιος 2022Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications in accordance with Regulation (EU) 2017/746News announcement13 Ιούνιος 2022MDCG 2022-11 - MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirementsNews announcement25 Μάιος 2022MDCG 2022-10 - Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746Δείτε τα όλα Highlights Benchmarks 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 announcement24 Μάιος 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devicesNews announcement26 Μάιος 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 activitiesCommission Implementing Regulation (EU) 2020/1207 on common specifications for the reprocessing of single-use devices Events 07Μάιος2021 Συναντήσεις εταίρων Webinar for Patients – Safe and performant Medical Devices for all Documents EventsPublications
News announcement13 Ιούλιος 2022MDCG 2022-12 - Harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for IVDR)
News announcement5 Ιούλιος 2022Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications in accordance with Regulation (EU) 2017/746
News announcement13 Ιούνιος 2022MDCG 2022-11 - MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements
News announcement25 Μάιος 2022MDCG 2022-10 - Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746
26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EU
News announcement24 Μάιος 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices
News announcement26 Μάιος 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
Commission Implementing Regulation (EU) 2020/1207 on common specifications for the reprocessing of single-use devices
