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TEAM-NB Recommandations

Reference Title
  Recommandations of Notified Bodies Medical Devices
NB-MED/2.1/Rec1 Representative Sample
NB-MED/2.1/Rec2 Explanation of Terms
NB-MED/2.1/Rec3 Accessories and other parts for Active Implantable Medical Devices
NB-MED/2.1/Rec4 Medical devices with a measuring function
NB-MED/2.1/Rec5 Placing on the market of fully refurbished medical devices
NB-MED/2.2/Rec1 EMC requirements
NB-MED/2.2/Rec2 Treatment of computer used to program Active Implantable Medical Devices (AIMD)
NB-MED/2.2/Rec3 "Use-by" date for Medical Devices
NB-MED/2.2/Rec4 Software and MEdical Devices
NB-MED/2.5.1/Rec4 Content of mandatory certificates
NB-MED/2.5.1/Rec5 Technical Documentation
NB-MED/2.5.1/Rec6 Renewal of EC Design-Examination and Type-Examination Certificates
NB-MED/2.5.2/Rec1 Subcontracting - QS related
NB-MED/2.5.2/Rec2 Reporting of design changes and changes of the quality system
NB-MED/2.5.2/Rec3 Translation procedure
NB-MED/2.5.4/Rec1 Homogeneous batches
NB-MED/2.5.4/Rec2 Verification of Manufactured Products for the IVD Directive
NB-MED/2.5.5/Rec1 Conformity assessment procedures of breast implants
NB-MED/2.5.5/Rec2 Combination of CE-marked and non-CE-marked medical devices and non-medical devices
NB-MED/2.5.5/Rec3 Conformity Assessment of Annex II, IVD's designed and evaluated prior to adoption of Common Technical Specifications (CTS)
NB-MED/2.5.5/Rec4 Assessment of the sensitivity of In Vitro Diagnostic Medical Devices - guidance on the application of the CTS
NB-MED/2.7/Rec1 Guidance on clinicals
NB-MED/2.7/Rec3 Evaluation of clinical data
NB-MED/2.12/Rec1 Post-Marketing Surveillance (PMS) post market/production
NB-MED/2.13/Rec1 CE-Marking of pre-MDD devices
NB-MED/2.13/Rec2 CE-Marking of established IVD devices
NB-MED/2.15/Rec1 Voluntary certification at an intermediate stage of manufacture
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