To a large extend, the processes that lead to the issuing of a European Technical Assessment have been specified in Regulation (EU) N° 305/2011 and complementary EOTA documents.
The European Technical Assessment process comprises three main steps:
Submission of an application, examination of the admissibility and confirmation of the admissibility
A manufacturer wishing to obtain a European Technical Assessment, should submit an application.
Having received the application, the UBAtc secretariat will contact the applicant, confirming receipt of the application and providing him with a file reference (e.g. AG123412-E). This unique file reference prevents confusion when communicating about a given file.
Simultaneously, the UBAtc secretariat will contact the approval operator responsible for the technical domain that covers the application. Upon the verification performed by the approval operator, amongst others based on the applicant’s technical file, the UBAtc secretariat will inform the applicant through the declaration of admissibility:
- Whether the product(s) in question may be examined by the approval operator and may lead to the issuing of a European Technical Assessment
- Whether a European Assessment Document needs to be amended or developed*
- The specialised group responsible for evaluating the file,
- The costs for the European Technical Assessment**
- The approval operator’s employee assigned to take care of the file
Having received the declaration of admissibility, the applicant should return the signed document to the UBAtc secretariat and the down payment.
The technical examination and the European Technical Assessment circulation process
The signed declaration of admissibility having been returned to the UBAtc secretariat and the down payment paid to the approval operator, the approval operator will study the file and present an evaluation plan. This plan specifies which evaluations need to take place (mostly tests to determine properties and performances) and which information still needs to be made available by the applicant. The evaluation plan is based on the European Assessment Document, adapted in accordance with the needs of the applicant and of the approval operator.
In case a new or amended European Assessment Document needs to be established, the approval operator will determine the content thereof in a work programme which needs to be adopted by EOTA. To prevent unnecessary work, the approval operator will develop the draft European Assessment Document together with the work programme. Once the work programme has been adopted, the European Assessment Document also needs to be made available to the other EOTA members. Consensus needs to be achieved at European level, before the European Assessment Document can be considered as adopted by EOTA. Having been adopted by EOTA, the European Commission also needs to accept the content of the European Assessment Document.
Once the applicant and the approval operator agree upon the evaluation plan, the approval operator will visit the production facility or facilities. This visit will, amongst others, be used to establish the control plan, i.e. an overview of verifications and tests that the ETA-holder needs to implement in the production facility or facilities. During this visit, the approval operator will perform sampling or have sampling performed under his responsibility. The applicant is responsible for ensuring that the necessary evaluation takes place. It is likely that the approval operator sets criteria with regards to the laboratory where the evaluation may take place (e.g. the laboratory will probably have to be accredited). In some cases, the approval operator may also require one or several site visits to see how the product or system is installed, executed, incorporated or assembled.
When the necessary inspections and evaluations have taken place, the approval operator will collect all the necessary reports and summarize those in an evaluation report. The evaluation report is the basis for the development of the (draft) European Technical Assessment text.
The (draft) European Technical Assessment text will be presented in a committee of experts with regards to the subject of the application (the operator’s executive board). This committee of independent experts treats all the information comprised in the evaluation report and the draft European Technical Assessment text confidentially. The outcome of discussions that take place in the executive board may lead to a favourable outcome, which means that the (draft) European Technical Assessment text will be presented to the operator’s specialized group, or may lead to further evaluation that needs to take place or additional information that the applicant needs to make available.
Having been discussed by the executive board, the approval operator will forward the (draft) European technical Assessment text to the UBAtc secretariat. The UBAtc secretariat will circulate the (draft) European technical Assessment for a one-month enquiry period during which other EOTA members may submit comments. The approval operator will normally try to take into account comments made by other EOTA member bodies before considering the European Technical Assessment text final. It is possible that – due to comments received – the file needs to be reconsidered by the executive board.
Once accepted by the executive board, the (draft) European Technical Assessment text may be presented to the committee of representatives of the relevant stakeholders of the (sub)sector with regards to the subject of the application (the operator’s specialised group).
Publication and assessment and verification of the constancy of performance (AVCP)
Once approved by the approval operator the (draft) European Technical Assessment will be forwarded by the approval operator to the UBAtc secretariat. Having checked the document to ensure that its format satisfies the requirements of the UBAtc, the UBAtc secretariat will forward the text to the applicant for proof reading. Where necessary taking into account comments submitted by the applicant, the document is finally signed by the management of the approval operator and the UBAtc and published on the UBAtc website.
When the European Technical Assessment has been published, in accordance with Regulation (EU) N° 305/2011, the holder of the European Technical Assessment needs to draw up a declaration of performance (the ‘DoP’) before affixing the CE marking on his products. The ETA-holder is only entitled to draw up a declaration of performance if the requirements regarding assessment and verification of the constancy of performance have been fulfilled, which may involve a third party, i.e. a notified body. The requirements regarding assessment and verification of the constancy of performance will be specified in the European Assessment Document, which may be further specified in the European Technical Assessment and the control plan which is agreed upon between the approval operator and the holder of the European Technical Assessment.