MODULE B- EU Type Examination

1. EU type examination is a conformity assessment process in which the technical design of the EU fertilization product is examined and it is verified and approved that this design complies with the relevant rules of technical legislation.

2. EU type examination can be carried out following one of the following methods:
a) Analysis of a sample (production type) representing the finished product in the production process.
b) Determination of the suitability of the product design and evaluation of a sample of at least one of the important components of the planned product (combination of production and design types), by review of the technical dossier of the product and the additional evidence specified.
c) Determining the suitability of the product design by evaluating only the technical file and additional documents without the need to examine the design type (sample) sample.

3. The manufacturer applies to a single authorized institution of its choice for EU type examination. Application documents available include:
a) Name and address information of the manufacturer; If the application is made by an authorized representative, the name and address information of this representative is also added,
b) A written statement stating that the relevant application has not been submitted to any other authorized organization,
c) Technical file. This technical file must contain all the information required to evaluate the compliance of the product with the relevant legislation and must present the risk analysis and evaluation processes in a comprehensive manner. The technical dossier describes all applicable standards and rules for the product and details the design, manufacture and functionality of the product in relation to the evaluation process. The technical dossier must contain at least the following information wherever applicable:
a) a comprehensive description of the EU fertilization product and a description of its intended use corresponding to its declared function,
b) EU fertilization product concept design, a list of component materials used, information on manufacturing processes,
c) Declaration of conformity of the EU fertilization product,
d) Drawings, diagrams and explanations necessary to understand the manufacturing process of the EU fertilization product,
d) Sample of a label or brochure or both containing the required information
e) In the case of partially applied harmonized standards or common specifications, technical documents apply sections,
f) technical and administrative evidence showing that the EU fertilization product complies with the application procedures or adopted national measures, if it contains by-products;
g) If the EU fertilizer product contains derived products, the commercial documents or health certificates required under the legislation in question and documents proving that the derived products have reached the final point in the production chain within the scope of this legislation,
h) results of calculations made, examinations carried out, etc.
i) Product test reports
d) Samples representing the product intended to be produced. The notified body may request additional samples if necessary for the testing programme.
d) Evidence supporting the adequacy of technical design solutions. This supporting evidence refers to any documents used, particularly where relevant harmonized national standards and/or technical specifications have not been fully implemented. This supporting evidence shall include, where necessary, the results of tests performed by the manufacturer’s appropriately qualified laboratory or by another laboratory on behalf of and under the responsibility of the manufacturer.

4. By the approved organization;
a) Regarding the product, the technical file and relevant supporting evidence are reviewed in order to determine whether the technical design of the product is sufficient,
b) Regarding the sample;
b-1) The conformity of the produced sample with the conditions in the technical file is confirmed and the items designed both in accordance with harmonized national standards and/or technical specifications and those designed without adhering to these standards or specifications are determined,
b-2) In cases where the manufacturer has adopted harmonized national standards and/or solutions in technical specifications, it carries out or ensures that the necessary tests and inspections are carried out to check whether these solutions are implemented correctly,
b-3) In cases where the methods specified in harmonized national standards and/or technical specifications are not used, it carries out or has the necessary tests and examinations carried out to determine whether the alternative solutions chosen by the manufacturer meet the basic requirements of the technical regulations,
b-4) It reaches an agreement with the manufacturer about the place to be used for the examination and tests.

5.The approved body creates an inspection report covering the transactions carried out in accordance with the fourth article and their results. The notified body may disclose part or all of the contents of this report only with the consent of the manufacturer, without prejudice to its responsibilities towards the authorized body that appointed it.

6. If the type evaluated meets the relevant rules of the technical legislation, the notified body issues an EU type examination certificate to the manufacturer. This document contains the name and address of the Manufacturer, the results of the examination, the validity of the document and the information necessary to identify the approved type. The document may contain one or more annexes and contains all necessary information that will allow in-production control and assessment of conformity to the type inspected. If the type does not meet the relevant rules of the technical legislation, the notified body refuses to issue the EU type examination certificate and informs the applicant with detailed justifications for the decision to refuse.

7. The notified body monitors the most up-to-date technological developments of the sector and evaluates whether these developments further meet the necessary criteria of the technical regulations of the approved type and decides whether these developments require additional evaluation. If additional evaluation is required, notifies the manufacturer. The manufacturer is obliged to notify the notified body that keeps the technical file of the relevant EU type-examination certificate of any changes that may affect the compliance of the approved type with the essential requirements of the technical legislation or the validity conditions of the EU type-examination certificate. Such changes require updating the EU type-examination certificate and obtaining additional approval.

8. Each notified body shall inform the competent authorities which appointed it of the EU type-examination certificates it has granted or withdrawn and/or any additions thereto, and shall, on a regular basis or upon request, notify these competent authorities of the documents it has refused to issue or suspended. or otherwise provides a list of the EU type-examination certificates and/or annexes thereto which it restricts. Each notified body shall inform other notified bodies of any EU type-examination certificates and/or additions thereto which it has refused, suspended, withdrawn or otherwise restricted and which it has granted upon request. The European Commission, European Union member states and other notified bodies can provide a copy of EU type examination certificates and/or annexes upon request. Upon request, the Commission and European Union member states may also provide a copy of the technical dossier and the results of the examination carried out by the notified body. The notified body shall keep a copy of the EU type-examination certificate, its annexes and annexes, and a copy of the technical file including the documents submitted by the manufacturer, until the end of the validity period of the EU type-examination certificate.

9. The notifying organization must keep a copy of the EU-type inspection certificate, its annexes and annexes, as well as the technical file containing the documents submitted by the manufacturer, until the validity period of the EU-type inspection certificate expires. The manufacturer must make available to national authorities a copy of the EU type examination certificate, annexes and annexes, as well as technical documentation for 5 years after the EU fertilizer product has been placed on the market.

10. The authorized representative of the manufacturer may make the application specified in the third article and fulfill the obligations listed in the seventh and ninth articles, provided that it is specified in the relevant assignment.