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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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Guidance document - Classification of Medical Devices - MEDDEV 2.4/1 rev.9
Document date: Sat Jun 19 00:00:00 CEST 2010
- Created by GROW.R.4
- Publication date: Mon May 18 13:44:53 CEST 2015
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Guidance document - Clinical investigation, clinical evaluation - Clinical evaluation: Guide for manufacturers and notified bodies - MEDDEV 2.7/1 rev.3
Document date: Sat Dec 19 00:00:00 CET 2009
- Created by GROW.R.4
- Publication date: Mon May 18 08:08:23 CEST 2015
- Last update: Mon May 18 08:08:22 CEST 2015
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Guidance document - Scope, field of application, definition - Borderline products, drug-delivery products and medical devices incorporating, as integral part, an ancillary medicinal substance or an ancillary human blood derivative - MEDDEV 2.1/3 rev.3
Document date: Sat Dec 19 00:00:00 CET 2009
- Created by GROW.R.4
- Publication date: Mon May 18 10:00:12 CEST 2015
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Information on the relation between the revised Directives 90/385/EEC and 93/42/EEC concerning (active implantable) medical devices and Directive 2006/42/EC on machinery
Document date: Thu Aug 20 00:00:00 CEST 2009
- Created by GROW.R.4
- Publication date: Wed May 13 07:16:31 CEST 2015
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Information on the relation between the revised Directive 93/42/EEC concerning medical devices and Directive 89/686/EEC on personal protective equipment
Document date: Thu Aug 20 00:00:00 CEST 2009
- Created by GROW.R.4
- Publication date: Wed May 13 07:40:13 CEST 2015
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Informative document of the Commission’s services on implementation of directive 2007/47/EC amending directives 90/385/EEC, 93/42/EEC and 98/8/EC
Document date: Thu Jun 04 00:00:00 CEST 2009
- Created by GROW.R.4
- Publication date: Wed May 13 07:57:23 CEST 2015
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Guidance document - Committees/Working Groups contributing to the implementation of the Medical Device Directives - MEDDEV 2.15 rev.3
Document date: Fri Dec 19 00:00:00 CET 2008
- Created by GROW.R.4
- Publication date: Wed May 13 12:20:02 CEST 2015
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Guidance document Medical Devices - Clinical investigation, clinical evaluation - Guide for Competent Authorities in making an assessment of clinical investigation notification - MEDDEV 2.7/2
Document date: Thu Sep 25 00:00:00 CEST 2008
- Created by GROW.DDG1.D.4
- Publication date: Mon Oct 12 14:46:03 CEST 2015
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Information on the Medical Devices Directives in relation to medical device own brand labellers
Document date: Sun Feb 03 00:00:00 CET 2008
- Created by GROW.R.4
- Publication date: Wed May 13 08:19:45 CEST 2015
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Guidance document - In vitro diagnostic medical devices - Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD) Medical Devices - MEDDEV 2.14/3 rev.1
Document date: Tue Jan 23 00:00:00 CET 2007
- Created by GROW.R.4
- Publication date: Wed May 13 12:04:27 CEST 2015
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