Notified Bodies Recommendations

NB-MED Recommendations sind Empfehlungspapiere, welche vom Europäischen Erfahrungsaustausch der Benannten Stellen im Bereich Medizinprodukte (NB-MED), an dem auch Vertreter der Herstellerverbände und EG-Kommission teilnehmen, verabschiedet wurden. Diese Empfehlungen sind nicht verbindlich. Obwohl sie konkrete Informationen zur Umsetzung der Richtlinien enthalten, sind Sie lediglich Interpretationshilfen für Hersteller, Benannte Stellen oder andere interessierte Kreise.

2.1 Scope, field of application, explanation of terms

 

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)

 

2.2 Essential Requirements

 

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)

 

2.5.1 Conformity assessment procedures; General rules

 

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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2.5.2 Conformity assessment procedures; Quality assurance

 

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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2.5.4 Conformity assessment procedures; Verification of manufactured products

 

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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2.5.5 Conformity assessment for particular product groups

 

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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2.7 Clinical investigations, clinical evaluation

 

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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2.12 Market surveillance; vigilance

 

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

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2.13 Transitional provisions

 

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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2.15 Other

 

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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