INTRODUCTION TO CE MARKING 2014/53/EU

from our beginning in FCC

The Radio Equipment Directive (RED)

CE Marking – 2014/53/EU RED

An Introduction to the conformity assessment procedure

  • Module A – Internal Production Control (A.K.A. Self DoC)
    The normal compliance route
  • Module B – Use of Notified Body (NB)
    Use of NB, required if harmonised standards not used
  • Module C – Conformity to type based on internal production control
    Use of NB, required if harmonised standards not used

MODULE A

INTERNAL PRODUCTION CONTROL (DOC)

Manufacturer shall, on their sole responsibility.

  • Perform conformity assessment of the product type
    Testing by manufacturer or 3rd party
  • Testing in full to harmonized standards
  • Prepare all Technical Documentation
  • Monitor manufacturing process to ensure conformity
    of the apparatus with the type assessed in step 1
  • Affix the CE marking to each individual apparatus
    that is in conformity with the type assessed
  • 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

  • Module B is not used alone but rather in conjunction with Module C.
  • Module B utilizes the technical expertise of a Notified Body to examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the apparatus. There is typically no examination of a specimen.
  • The manufacturer or authorized representative chooses a SINGLE NOTIFIED BODY from EU or MRA Country such as the United States.
  • Additionally, a declaration to the NB is made affirming that the same application has not been sent to another NB (NB will check)

THE APPLICATION

  • shall include;
  • Supporting evidence for the adequacy of the technical design solution and any documents that have been used, in particular when relevant harmonized standards have not been applied in full.
  • Where applicable, the results of tests carried out by a lab (Test Report)
  • Specifics of what part of the essential requirements are to be assessed (e.g. only article 3.2 effective and efficient use of spectrum)

A NOTIFIED BODY SHALL

  • Examine the technical documentation and supporting evidence
  • Assess the adequacy of the technical design
  • Produce an evaluation report recording activities
  • Released in full or in part by applicant consent

CERTIFICATE / LETTER

  • If the report is negative, no certificate, issue “letter of refusal” instead
  • Detailed response as to the refusal reason
  • Require applicant to take corrective measures
  • If the type meets the assessed requirements, issue EU-type examination certificate

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

  • Ensure/declare that equipment concerned is in conformity with the type covered by the EU-type examination certificate received from NB.
  • Prepare all Technical Documentation. (Before Module B process)
  • Monitor manufacturing process to ensure conformity of the apparatus with the type covered by the certificate.
  • Affix the CE marking to each individual apparatus that is in conformity with the type covered by the type certificate.
  • 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

  • Harmonized standards not used in full or do not exist.
  • Unit meets meets essential requirements, but was not tested in full to harmonised standards.
  • Too many product variants and testing of all configurations may be impractical.
  • The apparatus is too large to test as per requirements.

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.