| Steering Committee_Ad_Hoc_WG_procdures_neum1-2 |
12/11/2007 |
| SG2 N87r7 PD An XML Schema for the electronic transfer of adverse event data |
12/11/2007 |
| First Draft Revision OF Directive |
12/11/2007 |
| Europe and revision to ISO 13485 |
12/11/2007 |
| First Draft Revision OF Directive – Revision to 93-42-EEC First draft 22 March 2004 |
12/11/2007 |
| European GHTF Members as at 08 March 2007 |
12/11/2007 |
| European GHTF Members 2007 |
12/11/2007 |
| IVDD_ Classify7_non attributed comments_collated (4) |
12/11/2007 |
| IVDD_ Classify8_SG1(PD)N45R12_Feb07 (3) |
12/11/2007 |
| IVDD_Conformity Assessment SG1(PD)N046 R3_Feb07 (3) |
12/11/2007 |
| Doc EG 017-03-04 E-mail from Masako Kaufman |
12/11/2007 |
| Consensus-Statements-Own-Brand_2005_04 |
12/11/2007 |
| BackgroundRevisionArt14b rev1 CB |
12/11/2007 |
| Austrian update 25 June 2004 |
12/11/2007 |
| Affaires-Reglementaires-Animal-Tissue-199902 |
12/11/2007 |
| Reclassification-Final-Report-Howard-Dobbs-200310 |
12/06/2007 |
| Reclassification-Final-Legal-Opinion-20031015 |
12/06/2007 |
| RECOMM_12_2001 |
12/06/2007 |
| Evaluation of clinical data-R2_7-3_rev5 |
12/06/2007 |
| Guidance on clinicals-R2_7-1_rev2 |
12/06/2007 |
| Assess. of the sensitivity of IVD MD-guidance on the application of the CTS -R2_5_5-4_rev |
12/06/2007 |
| Conf. Asses. of Annex II, IVDs designed & evaluated prior to adoption of CTS-R2_5_5-3_rev1 |
12/06/2007 |
| Combination of CE-marked and non-CE-marked medical-R2_5_5-2_rev9 |
12/06/2007 |
| Conformity assessment procedures of breast implants-R2_5_5-1_rev5 |
12/06/2007 |
| Homogeneous batches-R2_5_4-1_rev4 |
12/06/2007 |
| CE-Marking of pre-MDD devicesR2_13-1_rev3 |
12/06/2007 |
| Post-Marketing Surveillance (PMS)-R2_12-1_rev11 |
12/06/2007 |
| Translation procedure-R2_5_2-3_rev9 |
12/06/2007 |
| Reporting of design changes and changes of the quality-R2_5_2-2_rev7 |
12/06/2007 |
| Subcontracting – QS relatedR2_5_2-1_rev4 |
12/06/2007 |
| Renewal of EC Design-Examination and Type-Examination-R2_5_1-6_rev4 |
12/06/2007 |
| Technical Documentation-R2_5_1-5_rev4 hot! |
12/06/2007 |
| Software and Medical Devices-R2_2-4_rev5 |
12/06/2007 |
| Use-by date for Medical Devices-R2_2-3_rev4 |
12/06/2007 |
| Treatment of computer used to program AIMD-R2_2-2_rev3 |
12/06/2007 |
| EMC requirements-R2_2-1_rev1 |
12/06/2007 |
| Voluntary certification at an intermediate stage of-R2_15-1_rev3 |
12/06/2007 |
| CE-Marking of established IVD devices-R2_13-2_rev3 |
12/06/2007 |
| Content of mandatory certificates-R2_5_1-4_rev4 |
12/06/2007 |
| STED pd_sg1_n011r17 |
12/06/2007 |
| Suppl Notes-March 05 Mtg- Fin-2003/32/EC |
12/06/2007 |
| Annex_1_to_07_ENTR_BC_05_UK_Comments |
12/05/2007 |
| Annex 3 to 07 ENTR BC 05 EUCOMED COMMENTS |
12/05/2007 |
| 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 |
| RoHs Dir-EN. |
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 |
12/04/2007 |
| Note from Dr Garcia |
12/04/2007 |
| Content of Field Safety Notices. |
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 |
12/03/2007 |
| Rubber Latex.200402 |
12/03/2007 |
| G.o.A. of M.D. materials of animal origin with respect to viruses.19990299 |
11/28/2007 |
| G.C.A. Breast Implants according Dir.. 93/42/ECCrelating to M.D.07-1998 |
11/28/2007 |
| HOMOGENEOUS BATCHES.02-1998. |
11/28/2007 |
| COUNCIL DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE M.D.02-1998.2_5-5 |
11/28/2007 |
| COUNCIL DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE M. D.06-1998. |
11/28/2007 |
| GUIDELINES FOR THE CLASSIFICATION OF M.D.part2_07-2001 |
11/28/2007 |
| GUIDELINES FOR THE CLASSIFICATION.07-2001 |
11/28/2007 |
| COUNCIL DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE M.D.06-1998. |
11/28/2007 |
| COUNCIL DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE M.D.02-1998. |
11/28/2007 |
| COUNCIL DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE M.D. 06-1998 |
11/28/2007 |
| COUNCIL DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE M.D.03-1994. |
11/28/2007 |
| COUNCIL DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE M.D.07-2001 |
11/28/2007 |
| COUNCIL DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE M.D.02-1998.2.1 2-1 |
11/28/2007 |
| Guidance Committees / Working parties relevant for Medical Devices |
11/28/2007 |
| IVD-Borderline Issues-200401 |
11/28/2007 |
| Minutes-Meeting M.D. Expert Group 200407-06 |
11/28/2007 |
| IFU & IVD Guidance |
11/28/2007 |
| 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 |
11/27/2007 |
| Report on Conformity with Council Dir. 93/42/EEC and Commission Dir. 2003/32/EC |
11/27/2007 |
| Application of Council Dir. 93/42/EEC taking into account the commission Dir. 2003/82/EC – TSE Risk hot! |
11/27/2007 |
| Designation & Monitoring of N.B. within the framework of ED Dir. on M.D. |
11/27/2007 |
| Rules of Accreditaiton for Cert. Bodies of Q.S. |
11/27/2007 |
| 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 |
