What is Conformity Assessment Procedure?

The conformity assessment procedures is the route by which manufacturer demonstrates compliance to applicable directive that their devices meet the Essential Requirements, for affixing CE Mark on manufactured Medical Device.

Various Conformity assessment routes and details on the various options available to the manufacturer for different classes of devices are set out in the Directive. The Notified Body assess the Quality Management System as per EN 46000 series of standards, particular requirements for Medical Device manufacturers' in addition to the ISO 9000 Series.

Class I
Sterile / Measuring
Annex VII + Annex V
for Sterile / Measuring aspects
Class II a Annex II
Annex VII + V
Annex VII + VI
Class II b Annex II
Annex III + V
Annex III + VI
Class III Annex II
Annex III + V

Table 2 ( CE Mark Conformity assessment route)

Annexes 1 1 S 1M 11a 11b 111
11( + Sec.4)          
11( - Sec.4)        

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