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.
Manufacturer's Name, Address & contact numbers
Devices coding, model number, serial number and description
Application of the device
Uniqueness of the device
Directive/s which compliance is claimed & steps taken
to achieve compliance with them
Harmonised, National or other Standards & any other
Technical Specifications applied for compliance with the Directive/s &
manufactured to
Additional information as relevant
Details of any component devices or accessories incorporated
Notified Body involvement if relevant
Contact numbers / addresses for safety issues
EU Authorised Representative
Date of Declaration
Location issuing Declaration
Signature / authorisation and designation of the Agent
making the Declaration on behalf of the organisation
