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Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR
Document date: Thu Oct 10 00:00:00 CEST 2019
- Created by GROW.DDG1.D.4
- Publication date: n/a
- Last update: Fri Oct 11 13:42:19 CEST 2019
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Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC
Document date: Thu Oct 03 00:00:00 CEST 2019
- Created by GROW.DDG1.D.4
- Publication date: n/a
- Last update: Fri Oct 04 12:24:07 CEST 2019
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Application form - Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05) -
Document date: Sun Sep 29 00:00:00 CEST 2019
- Created by GROW.DDG1.D.4
- Publication date: n/a
- Last update: Mon Sep 30 08:19:37 CEST 2019
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Procedural guidance on declaration of interests - Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05)
Document date: Sun Sep 29 00:00:00 CEST 2019
- Created by GROW.DDG1.D.4
- Publication date: n/a
- Last update: Mon Sep 30 08:28:42 CEST 2019
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Declarations on confidentiality and commitment - Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05)
Document date: Sun Sep 29 00:00:00 CEST 2019
- Created by GROW.DDG1.D.4
- Publication date: n/a
- Last update: Mon Sep 30 08:34:03 CEST 2019
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Manufacturer incident report Helptext 2020
Document date: Sun Sep 29 00:00:00 CEST 2019
- Created by GROW.DDG1.D.4
- Publication date: n/a
- Last update: Mon Sep 30 10:50:43 CEST 2019
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DSVG 03 - Cardiac Implantable Electronic Devices (CIED) - Guidance on the vigilance system for CE-marked medical devices
Document date: Wed Sep 25 00:00:00 CEST 2019
- Created by GROW.DDG1.D.4
- Publication date: n/a
- Last update: Thu Sep 26 15:12:38 CEST 2019
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DSVG 04 - Breast Implants - Guidance on the vigilance system for CE-marked medical devices
Document date: Wed Sep 25 00:00:00 CEST 2019
- Created by GROW.DDG1.D.4
- Publication date: n/a
- Last update: Thu Sep 26 15:14:02 CEST 2019
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MDCG 2019-9 Summary of safety and clinical performance A guide for manufacturers and notified bodies - August 2019
Document date: Wed Sep 25 00:00:00 CEST 2019
- Created by GROW.DDG1.D.4
- Publication date: n/a
- Last update: Fri Sep 27 13:04:33 CEST 2019
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Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8
Document date: Tue Jul 09 00:00:00 CEST 2019
- Created by GROW.DDG1.D.4
- Publication date: Wed Jul 10 13:45:31 CEST 2019
- Last update: Wed Jul 10 13:46:00 CEST 2019
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European Commission expert panels on medical devices and in vitro diagnostic devices
Document date: Thu Jun 20 00:00:00 CEST 2019
- Created by GROW.A.1.DIR
- Publication date: Fri Jun 21 11:50:31 CEST 2019
- Last update: Fri Jun 21 11:51:00 CEST 2019
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MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a "person responsible for regulatory compliance" (PRRC)
Document date: Wed Jun 19 00:00:00 CEST 2019
- Created by GROW.DDG1.D.4
- Publication date: Mon Jul 01 12:52:08 CEST 2019
- Last update: Mon Jul 01 12:52:32 CEST 2019
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Medical Devices: 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: Wed Jun 19 00:00:00 CEST 2019
- Created by GROW.DDG1.D.4
- Publication date: Mon Jul 01 12:57:41 CEST 2019
- Last update: Mon Jul 01 12:58:05 CEST 2019
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MDCG 2019-6 v2 Questions and answers: Requirements relating to notified bodies
Document date: Wed Jun 05 00:00:00 CEST 2019
- Created by GROW.DDG1.D.4
- Publication date: n/a
- Last update: Thu Oct 17 15:09:32 CEST 2019
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Factsheet for healthcare professionals and health institutions
Document date: Tue Jun 04 00:00:00 CEST 2019
- Created by GROW.A.1.DIR
- Publication date: Mon Jun 17 15:14:32 CEST 2019
- Last update: Mon Jun 17 15:15:01 CEST 2019
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Eudamed Data exchange services and entity models introductions
Document date: Tue May 28 00:00:00 CEST 2019
- Created by GROW.DDG1.D.4
- Publication date: Wed May 29 08:19:17 CEST 2019
- Last update: Wed May 29 08:19:34 CEST 2019
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M2M Data Exchange Services Definition
Document date: Tue May 28 00:00:00 CEST 2019
- Created by GROW.DDG1.D.4
- Publication date: Wed May 29 08:21:24 CEST 2019
- Last update: Wed May 29 08:21:33 CEST 2019
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Eudamed Data Exchange Guidelines
Document date: Tue May 28 00:00:00 CEST 2019
- Created by GROW.DDG1.D.4
- Publication date: Wed May 29 09:34:12 CEST 2019
- Last update: Wed May 29 09:34:35 CEST 2019
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TSE-BSE Contact points
Document date: Sun May 05 00:00:00 CEST 2019
- Created by GROW.DDG1.D.4
- Publication date: n/a
- Last update: Wed Aug 14 09:26:02 CEST 2019
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IVDR - UDI and device data sets to provide in EUDAMED
Document date: Thu May 02 00:00:00 CEST 2019
- Created by GROW.DDG1.D.4
- Publication date: Fri May 03 12:30:46 CEST 2019
- Last update: Fri May 03 12:31:09 CEST 2019
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MDR - UDI and device data sets to provide in EUDAMED
Document date: Thu May 02 00:00:00 CEST 2019
- Created by GROW.DDG1.D.4
- Publication date: Fri May 03 12:28:38 CEST 2019
- Last update: Fri May 03 12:29:14 CEST 2019
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EUDAMED UDI Device Data Dictionary
Document date: Thu May 02 00:00:00 CEST 2019
- Created by GROW.DDG1.D.4
- Publication date: n/a
- Last update: Wed Dec 04 09:46:30 CET 2019
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MDCG 2019-5 Registration of legacy devices in EUDAMED
Document date: Sun Apr 14 00:00:00 CEST 2019
- Created by GROW.DDG1.D.4
- Publication date: Mon Apr 15 09:02:11 CEST 2019
- Last update: Mon Apr 15 09:02:34 CEST 2019
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MDCG 2019-4 Timelines for registration of device data elements in EUDAMED
Document date: Sun Apr 14 00:00:00 CEST 2019
- Created by GROW.DDG1.D.4
- Publication date: Mon Apr 15 09:00:34 CEST 2019
- Last update: Mon Apr 15 09:01:03 CEST 2019
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MDCG 2019-3 Interpretation of Article 54(2)b
Document date: Thu Mar 21 00:00:00 CET 2019
- Created by GROW.DDG1.D.4
- Publication date: Fri Mar 22 10:04:19 CET 2019
- Last update: Fri Mar 22 10:04:38 CET 2019
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