NB-MED documents comprise of recommendations accepted by the European Forum of Notified Bodies Medical Devices (NB-MED). These recommendations are are not mandatory. Although they set out information on matters relating to the directives this is for guidance only, to help you to meet your obligations, whether you are a manufacturer, notified body or interested party.

Accessories and other parts for Active Implantable Medical Devices
(NB-MED Recommendation, 2.1/Rec3) 1996. Rev.-Nr. 2 Sprache: eng. (PDF)

Explanation of Terms
(NB-MED Recommendation, 2.1/Rec2) 1998. Rev.-Nr. 5 Sprache: eng. (PDF)

Medical devices with a measuring function
(NB-MED Recommendation, 2.1/Rec4) 1998. Rev.-Nr. 7 Sprache: eng. (PDF)

Placing on the market of fully refurbished medical devices
(NB-MED Recommendation, 2.1/Rec5) 2000. Rev.-Nr. 5 Sprache: eng. (PDF)

Representative Sample
(NB-MED Recommendation, 2.1/Rec1) 2000. Rev.-Nr. 4 Sprache: eng. (PDF)

EMC requirements
(NB-MED Recommendation, 2.2/Rec1) 1999. Rev.-Nr. 1 Sprache: eng. (PDF)

Software and Medical Devices
(NB-MED Recommendation, 2.2/Rec4) 2001. Rev.-Nr. 5 Sprache: eng. (PDF)

Treatment of computer used to program Active Implantable Medical Devices (AIMD)
(NB-MED Recommendation, 2.2/Rec2) 2000. Rev.-Nr. 3 Sprache: eng. (PDF)

“Use-by“ date for Medical Devices
(NB-MED Recommendation, 2.2/Rec3) 2000. Rev.-Nr. 4 Sprache: eng. (PDF)

Content of mandatory certificates
(NB-MED Recommendation, 2.5.1/Rec4) 1998. Rev.-Nr. 4 Sprache: eng. (PDF)

Renewal of EC Design-Examination and Type-Examination Certificates
(NB-MED Recommendation, 2.5.1/Rec6) 2000. Rev.-Nr. 4 Sprache: eng. (PDF)

Technical Documentation
(NB-MED Recommendation, 2.5.1/Rec5) 2000. Rev.-Nr. 4 Sprache: eng. (PDF)

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Reporting of design changes and changes of the quality system
(NB-MED Recommendation, 2.5.2/Rec2) 2008. Rev.-Nr. 8 Sprache: eng. (PDF)

Subcontracting - QS related
(NB-MED Recommendation, 2.5.2/Rec1) 2000. Rev.-Nr. 4 Sprache: eng. (PDF)

Translation procedure
(NB-MED Recommendation, 2.5.2/Rec3) 2000. Rev.-Nr. 9 Sprache: eng. (PDF)

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Homogeneous batches
(NB-MED Recommendation, 2.5.4/Rec1) 2000. Rev.-Nr. 4 Sprache: eng. (PDF)

Verification of Manufactured Products for the IVD Directive
(NB-MED Recommendation, 2.5.4/Rec2) 2000. Rev.-Nr. 3 Sprache: eng. (PDF)

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Assessment of the sensitivity of In Vitro Diagnostic Medical Devices - guidance on the application of the CTS
(NB-MED Recommendation, 2.5.5/Rec4) 2001. Rev.-Nr. 2 Sprache: eng. (PDF)

Combination of CE-marked and non-CE-marked medical devices and non-medical devices
(NB-MED Recommendation, 2.5.5/Rec2) 2001. Rev.-Nr. 9 Sprache: eng. (PDF)

Conformity Assessment of Own Brand Labelling
(NB-MED Recommendation, 2.5.5/Rec5) 2005. Draft Sprache: eng. (PDF)

Conformity assessment procedures for hip, knee and shoulder total joint replacements
(NB-MED Recommendation, 2.5.5/Rec2) 2006. Draft from NBRec meeting 13 November 2006 Sprache: eng. (PDF)

Conformity assessment procedures of breast implants
(NB-MED Recommendation, 2.5.5/Rec1) 2000. Rev.-Nr. 5 Sprache: eng. (PDF)

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Evaluation of clinical data
(NB-MED Recommendation, 2.7/Rec3) 1999. Rev.-Nr. 5 Sprache: eng. (PDF)

Guidance on clinicals
(NB-MED Recommendation, 2.7/Rec1) 1998. Rev.-Nr. 2 Sprache: eng. (PDF)

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Post-Marketing Surveillance (PMS) post market/production
(NB-MED Recommendation, 2.12/Rec1) 2000. Rev.-Nr. 11 Sprache: eng. (PDF)

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CE-Marking of established IVD devices
(NB-MED Recommendation, 2.13/Rec2) 2000. Rev.-Nr. 3 Sprache: eng. (PDF)

CE-Marking of pre-MDD devices
(NB-MED Recommendation, 2.13/Rec1) 1998. Rev.-Nr. 3 Sprache: eng. (PDF)

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Voluntary certification at an intermediate stage of manufacture
(NB-MED Recommendation, 2.15/Rec1) 2000. Rev.-Nr. 3 Sprache: eng. (PDF)

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