Conformity assessment procedure an introduction
- 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
Manufacturer chooses which modules;
- Module A (Normal compliance route!)
- Module B+C (use of NB, required if harmonised standards not used)
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
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
- Additionally, a declaration to the NB is made affirming that the
same application has not been sent to another NB (NB will check)
- 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
- 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
- Produce an evaluation report recording
- Released in full or in part by applicant
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
- 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
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
- 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;
- 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
The Declaration of Conformity
- Only a single DoC, even if more than one directive is
- 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
- Most severe directive is leading and sets minimum
content of DoC.