2014/30/EU EMC Directive

Conformity assessment procedure an introduction


Three Modules;

Manufacturer chooses which modules;

Module A

Internal Production Control (DoC)

Manufacturer shall, on their sole responsibility.

  1. Perform conformity assessment of the product type
    • testing by manufacturer or 3rd party
  2. Testing in full to harmonized standards
  3. Prepare all Technical Documentation
  4. Monitor manufacturing process to ensure conformity
    • of the apparatus with the type assessed in step 1
  5. Affix the CE marking to each individual apparatus
    • that is in conformity with the type assessed
  6. Make a Declaration of Conformity (DoC)
    • and keep a copy of the DoC
    • together with the technical documentation
    • at the disposal of the national authorities
    • for 10 years after the apparatus has been placed on the market

Module B

EC-Type Examination and Certification

The application

A Notified Body Shall

Certificate / Letter

Note: The Notified Body does not test, only an assessment is made of applicant’s technical documentation A test lab does not certify, only provides testing to manufacturer’s specifications

Module C

  1. Ensure/declare that equipment concerned is in conformity with the type covered by the EU-type examination certificate received from NB.
  2. Prepare all Technical Documentation. (Before Module B process)
  3. Monitor manufacturing process to ensure conformity of the apparatus with the type covered by the certificate.
  4. Affix the CE marking to each individual apparatus that is in conformity with the type covered by the type certificate.
  5. Make a Declaration of Conformity and keep a copy of the DoC and a copy of the EU-type examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the apparatus has been placed on the market.

When To Use Module B+C

The Certificate

  • If the type meets the assessed requirements, the NB shall issue an EU-type examination certificate.
  • The certificate shall contain at minimum;
    • Manufacturers name/address;
    • Necessary data for identification of the approved type
    • Conclusions of the examination
    • Conditions for certificate validity
  • The certificate may contain one or more annexes.
  • The certificate and it’s annexes shall contain all relevant information to allow the conformity of the apparatus with the examined type to be evaluated and to allow for in-service control.

The Declaration of Conformity

  • Only a single DoC, even if more than one directive is applicable.
  • The DoC shall have the “model structure” and shall be continuously updated.
  • It shall be in the language or languages required by the MS in which market the apparatus is placed or made available.
  • Most severe directive is leading and sets minimum content of DoC.
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