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