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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
Outcome of the first public consultation on the reprocessing of medical devices
Document date: Mon May 26 00:00:00 CEST 2008 - Created by GROW.R.4 - Publication date: Wed May 06 07:28:29 CEST 2015
Recast of the medical devices directives - public consultation
Document date: Mon May 05 00:00:00 CEST 2008 - Created by GROW.A.5 - Publication date: Fri Oct 09 11:38:21 CEST 2015 - Last update: Fri Oct 09 11:38:20 CEST 2015
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
Form for the registration of manufacturers and devices In Vitro Diagnostic Medical Device Directive, Article 10
Document date: Mon Oct 01 00:00:00 CEST 2007 - Created by GROW.R.4 - Publication date: Wed May 13 12:09:25 CEST 2015
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
Guidance document on Directive 2005/50/EC on the reclassification of hip, knee and shoulder joint replacements
Document date: Thu Jan 11 00:00:00 CET 2007 - Created by GROW.R.4 - Publication date: Wed May 13 09:23:20 CEST 2015
Guidance document on the demarcation between the cosmetic products Directive 76/768 and the medicinal products Directive 2001/83 as agreed between the commission services and the competent authorities of Member States
Document date: Tue Oct 04 00:00:00 CEST 2005 - Created by GROW.A.5 - Publication date: Mon Oct 12 12:32:29 CEST 2015
Public Consultation on a proposal for a Directive of the European Parliament and of the Council amending Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Document date: Tue May 10 00:00:00 CEST 2005 - Created by GROW.A.5 - Publication date: Thu Sep 24 07:20:46 CEST 2015
Guidance document - In vitro diagnostic medical devices - Research Use Only products - MEDDEV 2.14/2 rev.1
Document date: Thu Feb 19 00:00:00 CET 2004 - Created by GROW.R.4 - Publication date: Wed May 13 12:00:11 CEST 2015
Guidance document - Conformity assessment procedure - Evaluation of medical devices incorporating products containing natural rubber latex - MEDDEV 2.5/9 rev.1
Document date: Mon Feb 16 00:00:00 CET 2004 - Created by GROW.R.4 - Publication date: Mon May 18 07:17:57 CEST 2015
Guidance document - Notified bodies - Designation and monitoring of Notified Bodies within the framework of EC Directives on Medical devices - MEDDEV 2.10/2 rev.1
Document date: Thu Apr 19 00:00:00 CEST 2001 - Created by GROW.R.4 - Publication date: Wed May 13 11:50:55 CEST 2015
Guidance document - Conformity assessment procedure - Conformity assessment of breast implants - MEDDEV 2.5/7 rev.1
Document date: Sun Jul 19 00:00:00 CEST 1998 - Created by GROW.R.4 - Publication date: Wed May 13 11:08:45 CEST 2015
Guidance document - Medical devices with a measuring function - MEDDEV 2.1/5
Document date: Fri Jun 19 00:00:00 CEST 1998 - Created by GROW.R.4 - Publication date: Wed May 13 10:37:28 CEST 2015
Guidance document - Essential requirements - “Use by”-date - MEDDEV 2.2/3 rev.3
Document date: Fri Jun 19 00:00:00 CEST 1998 - Created by GROW.R.4 - Publication date: Wed May 13 10:58:31 CEST 2015
Guidance document - Conformity assessment procedure - Subcontracting quality systems related - MEDDEV 2.5/3 rev.2
Document date: Fri Jun 19 00:00:00 CEST 1998 - Created by GROW.R.4 - Publication date: Wed May 13 11:01:25 CEST 2015
Guidance document - Field of application of directive “active implantable medical devices” - Treatment of computers used to program implantable pulse generators - MEDDEV 2.1/2.1
Document date: Fri Feb 27 00:00:00 CET 1998 - Created by GROW.R.4 - Publication date: Wed May 13 10:22:46 CEST 2015
Guidance document - Essential requirements - Electromagnetic Compatibility (EMC) requirements - MEDDEV 2.2/1 rev.1
Document date: Thu Feb 19 00:00:00 CET 1998 - Created by GROW.R.4 - Publication date: Wed May 13 10:42:38 CEST 2015
Guidance document - Conformity assessment procedure - Translation procedure - MEDDEV 2.5/5 rev.3
Document date: Thu Feb 19 00:00:00 CET 1998 - Created by GROW.R.4 - Publication date: Wed May 13 10:46:35 CEST 2015 - Last update: Wed May 13 10:46:34 CEST 2015
Guidance document - Conformity assessment procedure - Homogenous batches (verification of manufacturers' products) - MEDDEV 2.5/6 rev.1
Document date: Thu Feb 19 00:00:00 CET 1998 - Created by GROW.R.4 - Publication date: Wed May 13 10:51:31 CEST 2015
Guidance document - Definitions of “medical devices”, “accessory” and “manufacturer” - MEDDEV 2.1/1
Document date: Fri Apr 29 00:00:00 CEST 1994 - Created by GROW.R.4 - Publication date: Wed May 13 10:03:48 CEST 2015
Guidance document - Field of application of directive “active implantable medical devices” - MEDDEV 2.1/2 rev.2
Document date: Mon Apr 25 00:00:00 CEST 1994 - Created by GROW.R.4 - Publication date: Wed May 13 10:16:45 CEST 2015
Guidance document - Interface with other directives – Medical devices/directive89/336/EEC relating to electromagnetic compatibility and directive 89/686/EEC relating to personal protective equipment - MEDDEV 2.1/4
Document date: Sat Mar 19 00:00:00 CET 1994 - Created by GROW.R.4 - Publication date: Wed May 13 10:31:08 CEST 2015 - Last update: Wed May 13 10:31:07 CEST 2015
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