EC Declaration of Conformity
Choices

Courtesy of M. Devices Ltd. You are freely licensed to use
our suggested Guide in preparing your EC Declaration of Conformity for
Class I, IIa, IIb & Class III devices.

The table includes the various Declarations that are possible and required by the Medical Devices Directive:
Annex II Declaration of Conformity According to Article 17 for a fixed number of devices manufactured
Annex II Declaration of Conformity EC Device Class III  Additional elements for design
Annex III Declaration of Conformity Compliance with the Essential Requirements
Annex IV Declaration of Conformity Per EC Type examination certificate
Annex IV Declaration of Conformity Per Verification test by Notified Body 
Annex V Declaration of Conformity Per EC Type examination certificate
Annex VI Declaration of Conformity Per fixed number of devices specified
Annex VII Declaration of Conformity Conformity
Annex VIII Declaration of non-conformity Per Essential Requirements and additional factors under investigation
Annex VIII Special Purpose Per applicable Essential Requirements 
Annex VIII Special Purpose Per protection precautions taken
Annex X Declaration of non-conformity Declare per Annex VIII
Annex X Special Purpose Declare per Annex VIII