| 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 |
| Team-NB Report NB-MED-2012100910-1 |
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-NB-MED-2.5.2 rec 2 Reporting of design changes and changes of the quality system |
11/16/2011 |
| Recommendation-Team-NB-List-20110114 |
01/14/2011 |
| Recommendation-NB-MED-R2_5_1-5_rev4 Technical Documentation hot! |
03/29/2010 |
| Recommendation-NB-MED-2_15-1_rev3 Voluntary certification at an intermediate stage of |
03/29/2010 |
| Recommendation-NB-MED-2_13-2_rev3 CE-Marking of established IVD devices |
03/29/2010 |
| Recommendation-NB-MED-2_13-1_rev3 CE-Marking of pre-MDD devices |
03/29/2010 |
| Recommendation-NB-MED-2_12-1_rev11 Post-Marketing Surveillance (PMS) hot! |
03/29/2010 |
| Recommendation-NB-MED-2_7-3_rev5 Evaluation of clinical data |
03/29/2010 |
| Recommendation-NB-MED-2_7-1_rev2 Guidance on clinicals |
03/29/2010 |
| Recommendation-NB-MED-2_5_5-Rec 5 Conformity Assessment of Own Brand Labelling hot! |
03/29/2010 |
| Recommendation-NB-MED-2_5_5 Rec2- Conformity assessment procedures for hip, knee and shoulder total |
03/29/2010 |
| Recommendation-NB-MED-2_5_5-4_rev2 Assessment of the sensitivity of In Vitro Diagnostic Medical |
03/29/2010 |
| Recommendation-NB-MED-2_5_5-3_rev1 Conformity Assessment of Annex II, IVD’s designed and |
03/29/2010 |
| Recommendation-NB-MED-2_5_5-2_rev9 Combination of CE-marked and non-CE-marked medical |
03/29/2010 |
| Recommendation-NB-MED-2_5_5-1_rev5 Conformity assessment procedures of breast implants |
03/29/2010 |
| Recommendation-NB-MED-2_5_4-2_rev3 Verification of Manufactured Products for the IVD Directive |
03/29/2010 |
| Recommendation-NB-MED-2_5_4-1_rev4 Homogeneous batches |
03/29/2010 |
| Recommendation-NB-MED-2_5_2-3_rev9 Translation procedure |
03/29/2010 |
| Recommendation-NB-MED-2_5_2-1_rev4 Subcontracting – QS related |
03/29/2010 |
| Recommendation-NB-MED-2_5_1-6_rev4 Renewal of EC Design-Examination and Type-Examination |
03/29/2010 |
| Recommendation-NB-MED-2_5_1-4_rev4 Content of mandatory certificates |
03/29/2010 |
| Recommendation-NB-MED-2_2 Rec1 EMC requirements |
03/29/2010 |
| Recommendation-NB-MED-2_2-4_rev5 Software and Medical Devices |
03/29/2010 |
| Recommendation-NB-MED-2_2-3_rev4 ‘Use-by’ date for Medical Devices |
03/29/2010 |
| Recommendation-NB-MED-2_2-2_rev3 Treatment of computer used to program Active Implantable |
03/29/2010 |
| Recommendation-NB-MED-2_1-5_rev5 Placing on the market of fully refurbished medical devices |
03/29/2010 |
| Recommendation-NB-MED-2_1-4_rev7 Medical devices with a measuring function |
03/29/2010 |
| Recommendation-NB-MED-2_1-3_rev2 Accessories and other parts for Active Implantable Medical |
03/29/2010 |
| Recommendation-NB-MED-2_1-2_rev5 Product-Device-Range-Category |
03/29/2010 |
| Recommendation-NB-MED-2_1-2_rev5 Explanation of Terms |
03/29/2010 |
| Recommendation-NB-MED-2_1-1_rev4 Representative Sample Recommendations |
03/29/2010 |
| Recommendation_Vigilance_after NB-Med_2007-04 |
03/29/2010 |
| NB-MED letter to MS on 2007_47 implementation |
12/04/2009 |
