CONTENTS

1.  Introduction to the guide

2.    Regulation

2.1.   European directives regarding medical devices / In 
         VitroDiagnostic medical devices and their 
         consequences for placing on the market in the 
         European Economic Area

2.1.1.   General
2.1.2.   Scope of the directives
2.1.3.   Essential requirements
2.1.4.   Importance of standards and their use
2.1.5.   Problems of interpretation
2.1.6.   Coordination of Notified Bodies

2.2.     Other directives to the taken into consideration where applicable
3.       With LNE / G-MED, how do you obtain the certificates required for CE marking ?
3.1.     Identification of the manufacturer and, where applicable, of the other parties
3.2.     Characterization of the products concerned
3.3.     Determining the applicable directive or directives
3.4.     Determining the class of the device (Directive 93/42/EEC case)

3.5.     Choice of the conformity assessment procedures
3.5.1.   Assessment procedures for directives 90/385/EEC (AIMD) and 93/42/EEC (medical    
             devices)
3.5.1.1. Examination of design (Annex II section 4)
3.5.1.2. EC type examination (Annex III)
3.5.1.3. Full quality assurance system (Annex II)
3.5.1.4. EC verification (Annex IV)
3.5.1.5. Production quality assurance (Annex V)
3.5.1.6. Product quality assurance (Annex VI)
 3.5.1.7. DEcleration of comfermity ( annex VII )
3.5.1.8. Particular case of software

3.5.2.   Assessment procedures for directive 98/79/EC (in vitro diagnostic medical devices)
3.5.2.1. Design examination (Annex IV section 4)
3.5.2.2. EC type examination (Annex V)
3.5.2.3. Full quality assurance system (Annex IV without sections 4 et 6)
3.5.2.4. EC verification (Annex VI)
3.5.2.5. Production quality assurance (Annex VII)
3.5.2.6. Product quality assurance
3.5.2.7. EC declaration of conformity (Annex III without section 6)
3.5.2.8. Verification of manufactured products
3.5.2.9. Particular case of software

3.6.       Horizontal themes
3.6.1.    Risk analysis
3.6.2.    Clinical evaluation
3.6.2.1. Guiding principles
3.6.2.2.  Practical approach
3.6.2.2.1. The notion of "clinical data" is pointless :
3.6.2.2.2. Clinical evidence is obviously acquired from the start :
3.6.2.2.3. The manufacturer provides sufficient data taken from the literature
3.6.2.2.4. The data consist of a clinical review.
3.6.2.2.5.  Data from the literature are not available, or not sufficient :
3.6.2.2.5.1. Compliance with the regulation relating to the conduct of
                      the clinical investigation
3.6.2.2.5.2. Pre-clinical data and contents of the clinical investigations plan
3.6.2.3.   Examination of clinical data
3.6.3.     Devices placed on the market in sterile condition
3.6.3.1.  first possibility
3.6.3.2. Second possibility :
3.6.4.   Establishing biocompatibility
3.6.5.   Establishing microbiological safety
3.6.6.   Devices with a measuring function
3.6.7.   Devices that incorporate medicinal drugs
3.6.8.   Device previously considered as medicines for placing on the market
3.7.     Course of the procedure with LNE / G-MED

4.       CE marking

5.       Maintaining the advantage of CE marking
5.1.     Full quality assurance system
5.1.1.  Where product design examination has been carried out
5.1.2.   General case

5.2. Production quality assurance
5.3. Product quality assurance
5.4. EC type examination
5.5. EC verification
5.6. EC declaration of conformity
5.7. Verification of manufactured products


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