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Questions & Answers
Document date: Mon Jul 24 00:00:00 CEST 2023
- Created by GROW.F.2
- Publication date: n/a
- Last update: 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
Document date: Thu Jul 17 00:00:00 CEST 2014
- Created by GROW.R.4
- Publication date: Tue May 19 06:45:10 CEST 2015
- Last update: Fri Oct 02 13:53:19 CEST 2015
Redirected to: 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
Document date: Sat Jan 19 00:00:00 CET 2013
- Created by GROW.DDG1.D.4
- Publication date: Tue Nov 06 15:11:17 CET 2018
- Last update: 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
Document date: Sat Jan 19 00:00:00 CET 2013
- Created by GROW.DDG1.D.4
- Publication date: Tue Nov 06 18:01:52 CET 2018
- Last update: 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
Document date: Mon Jan 30 00:00:00 CET 2012
- Created by GROW.R.4
- Publication date: 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
Document date: Mon Jan 30 00:00:00 CET 2012
- Created by GROW.R.4
- Publication date: 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
Document date: Mon Jan 23 00:00:00 CET 2012
- Created by GROW.R.4
- Publication date: 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
Document date: Wed Jan 18 00:00:00 CET 2012
- Created by GROW.R.4
- Publication date: 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
Document date: Wed Jan 18 00:00:00 CET 2012
- Created by GROW.DDG1.D.4
- Publication date: Fri Jul 15 08:03:00 CEST 2016
- Last update: 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
Document date: Wed Jan 11 00:00:00 CET 2012
- Created by GROW.R.4
- Publication date: Mon May 18 12:39:38 CEST 2015
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Manual of Decisions for Implementation of Directive 98/8/EC concerning the placing on the market of biocidal products
Document date: Tue Dec 20 00:00:00 CET 2011
- Created by GROW.R.4
- Publication date: Mon May 18 15:36:01 CEST 2015
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Information on the Customs Union Agreement with Turkey in the field of medical devices
Document date: Thu Feb 10 00:00:00 CET 2011
- Created by GROW.R.4
- Publication date: Wed May 13 08:50:35 CEST 2015
- Last update: Wed May 13 08:50:34 CEST 2015
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Guidance document - Clinical investigation, clinical evaluation - Clinical investigations: serious adverse event reporting - MEDDEV 2.7/3
Document date: Tue Dec 28 00:00:00 CET 2010
- Created by GROW.DDG1.D.4
- Publication date: Tue Apr 26 14:48:57 CEST 2016
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Guidance document Medical Devices - Clinical investigation, clinical evaluation - Guidelines on Clinical investigations: a guide for manufacturers and notified bodies - MEDDEV 2.7/4
Document date: Sun Dec 19 00:00:00 CET 2010
- Created by GROW.R.4
- Publication date: Mon May 18 13:02:02 CEST 2015
- Last update: Mon May 18 13:02:01 CEST 2015
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Informative document of the Commission’s services on placing on the market of medical devices
Document date: Mon Nov 15 00:00:00 CET 2010
- Created by GROW.R.4
- Publication date: Wed May 13 08:14:33 CEST 2015
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