Module A – Internal Production Control
Module B – Type Examination
Module C – Conformity to type based on internal production control
Module A (Standard compliance route!)
Module B+C (Voluntary use of NB)
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 designated 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 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 designated 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 immunity)
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 3-31
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
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.
Designated standards not used in full or do not exist.
Unit meets EMC standards not recognized by EU, but meets essential requirements.
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.
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