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Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context
Document date: 02/04/2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: 03/04/2020
Redirected to: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_guidance-active-implantable_en.pdf
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IMDRF Standards Checklist modified in scope of COVID-19
Document date: 31/03/2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: 03/04/2020
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State of play of joint assessments of Notified Bodies in the medical device sector
Document date: 17/03/2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: 18/03/2020
Redirected to: 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
Document date: 16/03/2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: 17/03/2020
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MDCG 2020-2 Class I Transitional provisions under Article 120 (3 and 4) – (MDR)
Document date: 16/03/2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: 17/03/2020
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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
Document date: 15/03/2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: 16/03/2020
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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
Document date: 15/03/2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: 17/03/2020
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MDCG 2018-1 v3 Guidance on BASIC UDI-DI and changes to UDI-DI
Document date: 15/03/2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: 17/03/2020
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Joint Implementation/preparedness plan on the new Medical Devices Regulation 2017/745 (MDR)
Document date: 10/03/2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: 13/03/2020
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NCARs statistics - 2019
Document date: 16/01/2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: 17/01/2020
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The CND Nomenclature - background and general principles
Document date: 09/01/2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: 10/01/2020
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The European Medical Device Nomenclature (EMDN) - the nomenclature of use in EUDAMED
Document date: 09/01/2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: 10/01/2020
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MDCG 2019-16 - Guidance on Cybersecurity for medical devices
Document date: 06/01/2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: 22/06/2020
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MDCG 2019-15 GUIDANCE NOTES FOR MANUFACTURERS OF CLASS I MEDICAL DEVICES
Document date: 16/12/2019
- Created by GROW.DDG1.D.4
- Publication date: n/a
- Last update: 17/12/2019
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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
Document date: 10/12/2019
- Created by GROW.DDG1.D.4
- Publication date: n/a
- Last update: 11/12/2019
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MDCG 2019-14 Explanatory note on MDR codes
Document date: 10/12/2019
- Created by GROW.DDG1.D.4
- Publication date: n/a
- Last update: 11/12/2019
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GS1 Basic UDI-DI
Document date: 03/12/2019
- Created by GROW.DDG1.D.4
- Publication date: n/a
- Last update: 04/12/2019
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HIBCC Basic UDI-DI
Document date: 03/12/2019
- Created by GROW.DDG1.D.4
- Publication date: n/a
- Last update: 04/12/2019
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ICCBBA UDI HRI & AIDC Formats
Document date: 03/12/2019
- Created by GROW.DDG1.D.4
- Publication date: n/a
- Last update: 04/12/2019
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HIBCC UDI HRI & AIDC Formats
Document date: 03/12/2019
- Created by GROW.DDG1.D.4
- Publication date: n/a
- Last update: 04/12/2019
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ICCBBA Basic UDI-DI
Document date: 03/12/2019
- Created by GROW.DDG1.D.4
- Publication date: n/a
- Last update: 04/12/2019
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IFA Basic UDI-DI
Document date: 03/12/2019
- Created by GROW.DDG1.D.4
- Publication date: n/a
- Last update: 04/12/2019
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IFA UDI HRI & AIDC Formats
Document date: 03/12/2019
- Created by GROW.DDG1.D.4
- Publication date: n/a
- Last update: 05/12/2019
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GS1 UDI HRI & AIDC Formats
Document date: 03/12/2019
- Created by GROW.DDG1.D.4
- Publication date: n/a
- Last update: 05/12/2019
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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)
Document date: 17/10/2019
- Created by GROW.DDG1.D.4
- Publication date: n/a
- Last update: 07/11/2019
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