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Team-nb Documents 2019-06-10T22:42:08+00:00

TEAM-NB DOCUMENTS

Code_of_Conduct_Medical_Notified-Bodies_v3-0 10/23/2012
Team-NB position regarding the Telegraph article 10/23/2012
Team-NB-Press-release-COC 10/23/2012
Code of Conduct Medical Notified Bodies v3-0 10/17/2012
Code of Conduct Medical Notified Bodies v2 7 07/10/2012
EUCOMED-EDMA-Position-Pape-concerning-CMC-decision-N°3 07/09/2012
Team-NB-Meeting-Dalli-Minutes-20120405 04/17/2012
Team-NB-Statment on European Medical Device Regulatory Regime 03/27/2012
EN_60601-1_Implementation_NB-Med-comments_11 – V1 1 02/07/2012
Recommendation_Vigilance_after NB-Med_2007-04 03/29/2010
MDEG_-_2008-12_-_II-6.3._Mandatory_Languages_Requirements_for_Medical_Devices_update_Sept.08. dochot! 12/17/2008
TEAM-NB-Presentation-ppt hot! 10/15/2008
Recommendation-NB-MED-2-1-2 rev-b Explanation of Terms 04/07/2008
Process Improvements WG proposed scope 04/07/2008
GHTF_Kuala_Lumpur_GHTF_SC_draft_agenda 04/03/2008
GHTF_AD_HOC_WORKING_GROUPS 04/03/2008
European_GHTF_Members_2008 04/03/2008
Draft_AgendaGHTF_January_2008 04/03/2008
R2_1-2_rev5.Product-Device-Range-Category 04/02/2008
Labels17_IVD_Final_comments_template 04/02/2008
Labels17_IVD_FINAL 04/02/2008
Define19_Final_comments_template 04/01/2008
define19_final 04/01/2008
SG_5_GHTF.washington.oct2007. 03/26/2008
R2_1-1_rev4.Representative_Sample 03/14/2008
2_7.1.EVALUATION OF CLINICAL DATA.A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES 01/18/2008
2_12_1-rev_5-2007.GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM 01/18/2008
2.5.2.rev_3_._199906.General Information GHTF 01/18/2008
2_12-2_05-2004.GUIDELINES ON POST MARKET CLINICAL FOLLOW-UP 01/18/2008
report_form_manufacturers_incident_report 01/08/2008
ques for regulators chart only_DE (2) with COM comments clean 01/08/2008
finalreport5-6-02cor1_3-july02 01/08/2008
Working Draft – Clinical Investigation – N3R2 clean 01/08/2008
Registration for GHTF prepatory meeting Luebeck 2006. 01/08/2008
Placing on the market of fully refurbished medical devices-R2_1-5_rev5 01/08/2008
Medical devices with a measuring function-R2_1-4_rev7 01/07/2008
Accessories and other parts for Active Implantable Medical-R2_1-3_rev2 01/07/2008
Explanation of Terms 01/04/2008
IVDD_ Classify7_accompanying note_Mch07 (3) 01/04/2008
ISM2005-39a-Global Harmonization Task Force Study Group 2 – GHTF SG2 – Vigilance 29th Meeting 01/04/2008
ISM2005-39-Attachment3-Study Group 2 Workplan 01/04/2008
ISM2005-39-Anlage2-Implementation of SG2 Documents 01/04/2008
ISM2005-34a 01/04/2008
ISM2005-34-Teilnehmer 01/04/2008
ISM2005-34-Anlage2 01/04/2008
ISM2005-34-Anlage1 01/04/2008
ISM2005-26-Anlage1-Implementation of SG2 Documents 01/04/2008
GHTF 01/04/2008
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, IVD’s 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 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 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