IMDRF Standards Checklist modified in scope of COVID-19
Data documentului: Tue Mar 31 00:00:00 CEST 2020
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State of play of joint assessments of Notified Bodies in the medical device sector
Data documentului: Tue Mar 17 00:00:00 CET 2020
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- Ultima actualizare: Wed Mar 18 13:42:01 CET 2020
Redirecționate către: https://ec.europa.eu/health/sites/health/files/md_newregulations/docs/notifiedbodies_overview_en.pdf
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MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software
Data documentului: Mon Mar 16 00:00:00 CET 2020
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- Ultima actualizare: Tue Mar 17 13:42:01 CET 2020
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MDCG 2020-2 Class I Transitional provisions under Article 120 (3 and 4) – (MDR)
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Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD
Data documentului: Sun Mar 15 00:00:00 CET 2020
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- Ultima actualizare: Mon Mar 16 13:33:36 CET 2020
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MDCG 2019-8 v2 - Guidance document - Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
Data documentului: Sun Mar 15 00:00:00 CET 2020
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MDCG 2018-1 v3 Guidance on BASIC UDI-DI and changes to UDI-DI
Data documentului: Sun Mar 15 00:00:00 CET 2020
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- Ultima actualizare: Tue Mar 17 07:45:06 CET 2020
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Joint Implementation/preparedness plan on the new Medical Devices Regulation 2017/745 (MDR)
Data documentului: Tue Mar 10 00:00:00 CET 2020
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- Ultima actualizare: Fri Mar 13 12:16:30 CET 2020
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NCARs statistics - 2019
Data documentului: Thu Jan 16 00:00:00 CET 2020
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The CND Nomenclature - background and general principles
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The European Medical Device Nomenclature (EMDN) - the nomenclature of use in EUDAMED
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- Ultima actualizare: Fri Jan 10 14:56:04 CET 2020
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MDCG 2019-16 - Guidance on Cybersecurity for medical devices
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- Ultima actualizare: Mon Jun 22 08:59:30 CEST 2020
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MDCG 2019-15 GUIDANCE NOTES FOR MANUFACTURERS OF CLASS I MEDICAL DEVICES
Data documentului: Mon Dec 16 00:00:00 CET 2019
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- Ultima actualizare: Tue Dec 17 17:20:40 CET 2019
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MDCG 2019-13 Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation
Data documentului: Tue Dec 10 00:00:00 CET 2019
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MDCG 2019-14 Explanatory note on MDR codes
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GS1 Basic UDI-DI
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HIBCC Basic UDI-DI
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ICCBBA UDI HRI & AIDC Formats
Data documentului: Tue Dec 03 00:00:00 CET 2019
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- Ultima actualizare: Wed Dec 04 13:09:05 CET 2019
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HIBCC UDI HRI & AIDC Formats
Data documentului: Tue Dec 03 00:00:00 CET 2019
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- Ultima actualizare: Wed Dec 04 13:16:03 CET 2019
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ICCBBA Basic UDI-DI
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IFA Basic UDI-DI
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IFA UDI HRI & AIDC Formats
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- Ultima actualizare: Thu Dec 05 10:19:00 CET 2019
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GS1 UDI HRI & AIDC Formats
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- Ultima actualizare: Thu Dec 05 10:20:41 CET 2019
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Flyer - Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05)
Data documentului: Thu Oct 17 00:00:00 CEST 2019
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- Ultima actualizare: Thu Nov 07 10:18:41 CET 2019
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Designating authority's final assessment form: Key Information (EN)
Data documentului: Wed Oct 16 00:00:00 CEST 2019
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- Ultima actualizare: Wed Jun 10 14:13:01 CEST 2020
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