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Content
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IVD 98/79/EC
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MDD 93/42/EEC
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Essential requirements
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Annex I
Content comparable
Division into Part A and Part B
Part A - General Requirements and
Part B - Specific product related requirements
Clinical data are included in A.1,containing additional requirements
for products for self-testing (B.7)
Information to be given by the manufacturer are described in greater
detail (B.8)
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Annex I
requirements numbered 1-14
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Classification
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Annex II
Classification by lists
List A and List B
special rules for products for self testing (Article 9)
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Annex IX
Classification after rules
Class I, IIa, IIb, III special rules for Class Im and Is (in Annex
VIII)
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EG-Declaration
of Conformity
content of the technical documentation
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Annex III
Concrete content of the documentation
inclusive the process III.4 for Products for self testing
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Annex VII
inclusive the procedures for Class I sterile products and Class
I products with measuring function
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EG-Declaration
of Conformity
complete quality management system
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Annex IV
Inclusive Design Dossier
Examination IV.4
and
Batch release IV.6
for products of List A Annex II
For the batch release there is a maximum time period of 30 days,
after that the manufacturer may automatically consider conformity!
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Annex II
inclusive Design Dossier Examination II.4
for products of Class III
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