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Supporting documents for the final summary report on "Economic analysis of European competitiveness and integration 3" (MANUBASE-3)
Dokumentets dato: Tue Jul 30 00:00:00 CEST 2019
- Oprettet af GROW.A.1.DIR
- Publikationsdato: n/a
- Seneste opdatering: Tue Dec 10 13:50:08 CET 2019
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Exhaustive list of requirements for manufacturers of medical devices
Dokumentets dato: Mon Jul 23 00:00:00 CEST 2018
- Oprettet af GROW.DDG1.D.4
- Publikationsdato: Tue Jul 24 13:30:23 CEST 2018
- Seneste opdatering: Tue Jul 24 13:30:32 CEST 2018
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Clinical evaluation: a guide for manufacturers and notified bodies under directives 93/42 and 90/385
Dokumentets dato: Tue May 31 00:00:00 CEST 2016
- Oprettet af GROW.DDG1.D.4
- Publikationsdato: Wed Jun 29 07:15:42 CEST 2016
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Device specific vigilance guidance template
Dokumentets dato: Tue May 31 00:00:00 CEST 2016
- Oprettet af GROW.DDG1.D.4
- Publikationsdato: Wed Jun 29 07:31:45 CEST 2016
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Device Specific Vigilance Guidance - 02 Coronary Stents Vigilance Reporting Guidance and file attached
Dokumentets dato: Tue May 31 00:00:00 CEST 2016
- Oprettet af GROW.DDG1.D.4
- Publikationsdato: Tue Oct 18 13:26:56 CEST 2016
- Seneste opdatering: Tue Oct 18 13:27:05 CEST 2016
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Specific privacy statement - call for data on medical devices sterilised with ethylene oxide
Dokumentets dato: Thu Dec 03 00:00:00 CET 2015
- Oprettet af GROW.DDG1.D.4
- Publikationsdato: Fri Dec 04 10:17:13 CET 2015
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New Manufacturer Incident Report Form - Additional MIR form piloting arrangements
Dokumentets dato: Thu May 07 00:00:00 CEST 2015
- Oprettet af GROW.DDG1.I.4
- Publikationsdato: Fri May 08 07:21:02 CEST 2015
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MIR additional Information form
Dokumentets dato: Thu May 07 00:00:00 CEST 2015
- Oprettet af GROW.DDG1.I.4
- Publikationsdato: Fri May 08 07:36:54 CEST 2015
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New Manufacturer Incident Report Form - Additional MIR form piloting arrangements
Dokumentets dato: Thu May 07 00:00:00 CEST 2015
- Oprettet af GROW.DDG1.I.4
- Publikationsdato: Fri May 08 07:34:47 CEST 2015
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Guidance on participation and piloting of the introduction of the revised manufacturer incident report (MIR) form and trend reporting forms
Dokumentets dato: Thu May 07 00:00:00 CEST 2015
- Oprettet af GROW.DDG1.I.4
- Publikationsdato: Fri May 08 07:42:34 CEST 2015
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Nomenclature for patient harm
Dokumentets dato: Thu May 07 00:00:00 CEST 2015
- Oprettet af GROW.DDG1.I.4
- Publikationsdato: Fri May 08 07:46:24 CEST 2015
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Additional Guidance on completing the additional fields in pilot Manufacturer Incident Report form
Dokumentets dato: Thu May 07 00:00:00 CEST 2015
- Oprettet af GROW.DDG1.I.4
- Publikationsdato: Fri May 08 07:44:35 CEST 2015
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IVD related Event-type codes added to ISO/TS 19218-1
Dokumentets dato: Thu May 07 00:00:00 CEST 2015
- Oprettet af GROW.DDG1.I.4
- Publikationsdato: Fri May 08 07:51:28 CEST 2015
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IVD related Evaluation codes added to ISO/TS 19218-2
Dokumentets dato: Thu May 07 00:00:00 CEST 2015
- Oprettet af GROW.DDG1.I.4
- Publikationsdato: Fri May 08 07:53:48 CEST 2015
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Questions and Answers for the additional manufacturer incident report form pilot
Dokumentets dato: Thu May 07 00:00:00 CEST 2015
- Oprettet af GROW.DDG1.I.4
- Publikationsdato: Fri May 08 07:56:39 CEST 2015
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2015 dates for the EU additional MIR pilot form webinar/teleconferences
Dokumentets dato: Thu May 07 00:00:00 CEST 2015
- Oprettet af GROW.DDG1.I.4
- Publikationsdato: Fri May 08 07:58:39 CEST 2015
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Toolkit for users components list EU Vigilance Pilot on trending
Dokumentets dato: Thu May 07 00:00:00 CEST 2015
- Oprettet af GROW.DDG1.I.4
- Publikationsdato: Fri May 08 08:20:13 CEST 2015
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EU Vigilance Pilot on trending Step by step guide
Dokumentets dato: Mon May 04 00:00:00 CEST 2015
- Oprettet af GROW.DDG1.I.4
- Publikationsdato: Tue May 05 14:23:24 CEST 2015
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EU Vigilance Pilot MIR form
Dokumentets dato: Mon May 04 00:00:00 CEST 2015
- Oprettet af GROW.DDG1.D.4
- Publikationsdato: Tue Feb 09 08:09:16 CET 2016
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MEDDEV 2.1/1 Definition of medical devices, accessory and manufacturer
Dokumentets dato: Wed Mar 25 00:00:00 CET 2015
- Oprettet af GROW.DDG1.I.4
- Publikationsdato: Thu Mar 26 15:20:37 CET 2015
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Guidance Notes for Manufacturers of Custom-Made Medical Devices
Dokumentets dato: Tue Nov 10 00:00:00 CET 2009
- Oprettet af GROW.R.4
- Publikationsdato: Wed May 13 09:16:51 CEST 2015
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