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Privacy statement - Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05)
Document date: Thu Apr 23 00:00:00 CEST 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Fri Apr 24 14:13:33 CEST 2020
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MDCG 2020-9 Regulatory Requirements for Ventilators and Related Accessories
Document date: Thu Apr 23 00:00:00 CEST 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Mon Apr 27 06:57:32 CEST 2020
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MDCG 2020-5 Clinical Evaluation - Equivalence. A guide for manufacturers and notified bodies
Document date: Wed Apr 22 00:00:00 CEST 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Fri Apr 24 07:29:33 CEST 2020
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MDCG 2020-6 Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC. A guide for manufacturers and notified bodies
Document date: Wed Apr 22 00:00:00 CEST 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Fri Apr 24 07:33:41 CEST 2020
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MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies
Document date: Wed Apr 22 00:00:00 CEST 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Fri Apr 24 07:36:39 CEST 2020
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MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies
Document date: Wed Apr 22 00:00:00 CEST 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Fri Apr 24 07:38:42 CEST 2020
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Current performance of COVID-19 test methods and devices and proposed performance criteria - Working document of Commission services
Document date: Wed Apr 15 00:00:00 CEST 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Fri Apr 17 11:42:01 CEST 2020
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Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions
Document date: Tue Apr 07 00:00:00 CEST 2020
- Created by GROW.DDG1.D.DIR
- Publication date: n/a
- Last update: Wed Apr 08 12:25:03 CEST 2020
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MDCG 2019-3 Interpretation of Article 54(2)b rev 1
Document date: Sun Apr 05 00:00:00 CEST 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Tue Apr 07 07:55:33 CEST 2020
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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: Thu Apr 02 00:00:00 CEST 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Fri Apr 03 14:04:05 CEST 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: Tue Mar 31 00:00:00 CEST 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Fri Apr 03 13:52:03 CEST 2020
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State of play of joint assessments of Notified Bodies in the medical device sector
Document date: Tue Mar 17 00:00:00 CET 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Wed Mar 18 13:42:01 CET 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: Mon Mar 16 00:00:00 CET 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: 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)
Document date: Mon Mar 16 00:00:00 CET 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Tue Mar 17 13:45:04 CET 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: Sun Mar 15 00:00:00 CET 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Mon Mar 16 13:33:36 CET 2020
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