The EAD is the document which expresses the evaluation scheme harmonised at European level for non-standardised or innovative products and uses.
The EAD contains, as a minimum, a general description of the product, the list of essential characteristics relevant for the use intended by the manufacturer, and agreed between the manufacturer and EOTA, as well as the methods and criteria for the assessment of the product performances in relation with such essential characteristics. It also includes the cornerstones for the factory production control which have to be applied.
The EAD applies to products and uses not covered or not fully covered by a harmonised technical specification: harmonised European standard, EAD or ETA Guideline used as an EAD. In the case of harmonised standards, the EAD is applicable when:
- The product does not fall within the scope of any existing harmonised standard.
- For at least one essential characteristic of that product, the assessment method is not provided for in the harmonised standard or is not appropriate.
The EAD provides the basis for the later elaboration of the European Technical Assessment-ETA requested by the manufacturer and the subsequent Declaration of Performance and CE marking.
How to elaborate an EAD?
Annex II of the Regulation should be followed in conjunction with the internal procedures of EOTA.
The EAD process is initiated once the manufacturer’s request is confirmed by the Technical Assessment Body-TAB which received the application, in accordance with Art. 21(3) of the Regulation.
The EAD is developed within the Working Group of the TABs designated for the relevant Product Area under the leadership of the TAB which received the request (responsible TAB), under conditions of confidentiality.
Once the EAD is agreed, the responsible TAB can prepare the European Technical Assessment-ETA for the requested product and use. This involves the following tasks: preparation of the Test and/or Calculation Plan, execution of the tests and/or calculations, inspection of the manufacturing plant, assessment of the results and issue of the ETA.
At the end of the procedure laid down in Annex II of the Regulation, reference to the EAD is published by the European Commission in the OJEU and the document is made public by EOTA.
Can the existing ETA Guidelines and CUAP be used?
ETA Guidelines may be used as EAD for the ETA issue (Art. 66.3 of the Regulation).
Existing CUAP in the framework of the Directive shall be converted to and processed as EAD for the ETA issue.