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12/11/2007 |
| SG2 N87r7 PD An XML Schema for the electronic transfer of adverse event data |
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| First Draft Revision OF Directive |
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| Europe and revision to ISO 13485 |
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| First Draft Revision OF Directive – Revision to 93-42-EEC First draft 22 March 2004 |
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| European GHTF Members as at 08 March 2007 |
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| European GHTF Members 2007 |
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| Doc EG 017-03-04 E-mail from Masako Kaufman |
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| BackgroundRevisionArt14b rev1 CB |
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| Austrian update 25 June 2004 |
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| Affaires-Reglementaires-Animal-Tissue-199902 |
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| RECOMM_12_2001 |
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12/06/2007 |
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12/06/2007 |
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| STED pd_sg1_n011r17 |
12/06/2007 |
| Suppl Notes-March 05 Mtg- Fin-2003/32/EC |
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| Annex_1_to_07_ENTR_BC_05_UK_Comments |
12/05/2007 |
| Annex 4 to 07 ENTR BC 05 Enquiry form |
12/05/2007 |
| Annex 3 to 07 ENTR BC 05 EUCOMED COMMENTS |
12/05/2007 |
| Annex 4 to 07 ENTR BC 05 Enquiry form rev 1 |
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| Draft agenda Newport Beach California revision 20070404 |
12/05/2007 |
| Draft agenda Newport Beach California |
12/05/2007 |
| Annex 2 to 07 ENTR BC 05 MHRA Bulletin 17 |
12/05/2007 |
| Annex 1 to 07 ENTR BC 05 UK Comments |
12/05/2007 |
| Animal-Tissues |
12/05/2007 |
| AG%209.1%20TA%A0A6-0044-2006. |
12/05/2007 |
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12/05/2007 |
| TA?A6-0044-2006 |
12/05/2007 |
| COM Strateg_2005 |
12/05/2007 |
| MRA Austral- Sectoral Ann-Drft Fin |
12/05/2007 |
| Poster |
12/05/2007 |
| GPSDirective |
12/04/2007 |
| Borderline guidance |
12/04/2007 |
| Borderline guidance Annex23. |
12/04/2007 |
| Borderline guidance Annex1 |
12/04/2007 |
| Links to standards. |
12/04/2007 |
| Sect Ann-Drft Fin 2 clean. |
12/04/2007 |
| Clinical Evaluation.doc |
12/04/2007 |
| Clinical Evidence – Key Definitions and Concepts |
12/04/2007 |
| Proposed final documents _060402 |
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| Note from Dr Garcia |
12/04/2007 |
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12/04/2007 |
| National Competent Authority Report Exchange Criteria and Report Form |
12/04/2007 |
| Letter of Mr Garcia. |
12/04/2007 |
| NCAR Application |
12/04/2007 |
| Conformity_Assessment18_Consolidated2B_no source |
12/04/2007 |
| SG1-N40-2006 |
12/04/2007 |
| Classif34_Consolidated2B_no source |
12/04/2007 |
| Classif34_Consolidated2B_no source |
12/04/2007 |
| SG1-N15-2006 |
12/03/2007 |
| IVD Guidance Ver13_221106_FinalVersion |
12/03/2007 |
| ABHS_N_38_Achievements_of_the_ABHS |
12/03/2007 |
| Work Program on NET 07xxxx |
12/03/2007 |
| G. M.D.Vigilance System_2_12_draft_rev_5_-Fin |
12/03/2007 |
| Evaluation of clinicaldata.200304 |
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| Rubber Latex.200402 |
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| G.o.A. of M.D. materials of animal origin with respect to viruses.19990299 |
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| G.C.A. Breast Implants according Dir.. 93/42/ECCrelating to M.D.07-1998 |
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| HOMOGENEOUS BATCHES.02-1998. |
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| COUNCIL DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE M.D.02-1998.2_5-5 |
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| COUNCIL DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE M. D.06-1998. |
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| GUIDELINES FOR THE CLASSIFICATION OF M.D.part2_07-2001 |
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| GUIDELINES FOR THE CLASSIFICATION.07-2001 |
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| COUNCIL DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE M.D.06-1998. |
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| COUNCIL DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE M.D.02-1998. |
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| COUNCIL DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE M.D. 06-1998 |
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| COUNCIL DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE M.D.03-1994. |
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| COUNCIL DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE M.D.07-2001 |
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| COUNCIL DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE M.D.02-1998.2.1 2-1 |
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| Guidance Committees / Working parties relevant for Medical Devices |
11/28/2007 |
| IVD-Borderline Issues-200401 |
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| Minutes-Meeting M.D. Expert Group 200407-06 |
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| IFU & IVD Guidance |
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| IVD Guidance-Research Use Only products. |
11/27/2007 |
| OJCE-Application of transitional provision of Dir. 93/42/EEC relating to M.D. (98/C 242/05) |
11/27/2007 |
| Guidelines on Medical Devices Vigilance System |
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| Report on Conformity with Council Dir. 93/42/EEC and Commission Dir. 2003/32/EC |
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| Designation & Monitoring of N.B. within the framework of ED Dir. on M.D. |
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| Rules of Accreditaiton for Cert. Bodies of Q.S. |
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| Agenda Meeting April 2001 |
11/27/2007 |
| Qualification of personnel-Meeting April 2001 |
11/27/2007 |
| New Work Item Proposal |
11/27/2007 |
| ISO and GHTF Cooperation |
11/22/2007 |
