Questions & Answers
Dátum dokumentu: Mon Jul 24 00:00:00 CEST 2023
- Autor GROW.F.2
- Dátum uverejnenia: n/a
- Posledná aktualizácia: Mon Jul 24 16:34:30 CEST 2023
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Manual on borderline and classification in the community regulatory framework for medical devices
Dátum dokumentu: Thu Jul 17 00:00:00 CEST 2014
- Autor GROW.R.4
- Dátum uverejnenia: Tue May 19 06:45:10 CEST 2015
- Posledná aktualizácia: Fri Oct 02 13:53:19 CEST 2015
Presmerovaný na: http://ec.europa.eu/DocsRoom/documents/12867
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Guidance document - Market surveillance - Guidelines on a Medical Devices Vigilance System - MEDDEV 2.12/1 rev.8
Dátum dokumentu: Sat Jan 19 00:00:00 CET 2013
- Autor GROW.DDG1.D.4
- Dátum uverejnenia: Tue Nov 06 15:11:17 CET 2018
- Posledná aktualizácia: Tue Nov 06 15:12:32 CET 2018
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Guidance document - Market surveillance - Guidelines on a Medical Devices Vigilance System - MEDDEV 2.12/1 rev.8
Dátum dokumentu: Sat Jan 19 00:00:00 CET 2013
- Autor GROW.DDG1.D.4
- Dátum uverejnenia: Tue Nov 06 18:01:52 CET 2018
- Posledná aktualizácia: Wed Nov 28 13:16:04 CET 2018
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Guidance document - In vitro diagnostic medical devices - CE marking of blood based in vitro diagnostic medical devices for variant Creutzfeldt-Jakob Disease (vCJD) based on detection of abnormal PrP (host protein) - MEDDEV 2.14/4
Dátum dokumentu: Mon Jan 30 00:00:00 CET 2012
- Autor GROW.R.4
- Dátum uverejnenia: Mon May 18 13:54:40 CEST 2015
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Guidance document Medical Devices - Conformity assessment procedure - Guideline for Authorised Representatives - MEDDEV 2.5/10
Dátum dokumentu: Mon Jan 30 00:00:00 CET 2012
- Autor GROW.R.4
- Dátum uverejnenia: Mon May 18 14:03:25 CEST 2015
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Guidance document - In vitro diagnostic medical devices - Borderline and Classification issues. A guide for manufacturers and notified bodies - MEDDEV 2.14/1 rev.2
Dátum dokumentu: Mon Jan 23 00:00:00 CET 2012
- Autor GROW.R.4
- Dátum uverejnenia: Mon May 18 07:33:34 CEST 2015
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Guidance document Medical Devices - Essential requirements - Conformity assessment of In Vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) products - MEDDEV 2.2/4
Dátum dokumentu: Wed Jan 18 00:00:00 CET 2012
- Autor GROW.R.4
- Dátum uverejnenia: Mon May 18 14:08:22 CEST 2015
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Guidance document Medical Devices - Scope, field of application, definition - Qualification and Classification of stand alone software - MEDDEV 2.1/6
Dátum dokumentu: Wed Jan 18 00:00:00 CET 2012
- Autor GROW.DDG1.D.4
- Dátum uverejnenia: Fri Jul 15 08:03:00 CEST 2016
- Posledná aktualizácia: Fri Jul 15 08:04:00 CEST 2016
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Guidance document Medical devices - Market surveillance - Post Market Clinical Follow-up studies - MEDDEV 2.12/2 rev.2
Dátum dokumentu: Wed Jan 11 00:00:00 CET 2012
- Autor GROW.R.4
- Dátum uverejnenia: Mon May 18 12:39:38 CEST 2015
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