NB-MED DOCUMENTS

The documents displayed in this section are important documents edited in the framework of the NB-Med working group work. These documents are considered as important for the medical device sector and therefore made available in this section. It is to notice that Team-NB is not taking any responsibilities regarding the contents of the documents of this section.

 

Interim NB-Med consensus version on “Testing during unannounced Audits” V 2.3-October,13th, 2014new! 13/10/2014
Interim NB-Med consensus Version on “Interpretation and Application of Annexes Z in EN ISO 14971: 2012 V 1.1-October 13th, 2014new! 13/10/2014
Recommendation-NB-MED-2.5.2 rec 2 Reporting of design changes and changes of the quality system 11/16/2011
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
Recommendation-NB-MED-2-1-2 rev-b Explanation of Terms 04/07/2008