The Radio Equipment Directive
Module A – Internal Production Control (A.K.A. Self DoC)
Module B – Use of Notified Body (NB)
Module C – Conformity to type based on internal production control
Manufacturer chooses which modules;
Module A (Normal compliance route!)
Module B+C (use of NB, required if harmonised standards not used)
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 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)
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)
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
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
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.
If the type meets the assessed requirements, the NB shall issue an EU-type examination certificate.
The certificate shall contain at minimum;
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.