Regulation (EU) 2018/858 of the European Parliament and of the CouncilShow full title

Article 10 Assessments by the Commission

1. The Commission shall organise and carry out assessments of the procedures put in place by approval authorities that have granted EU type-approvals within the five years preceding the assessment, in particular of the procedures for granting type-approvals, for carrying out conformity of production and for the designation and monitoring of technical services. Such assessments shall include an evaluation, using a random sample, of the compliance of granted type-approvals with applicable requirements referred to in point (c) of Article 26(2) within the five years preceding the assessment.

2. The assessments shall aim to assist the approval authorities that grant EU type-approvals to ensure the uniform application of this Regulation and to share best practices.

3. The assessments shall be carried out in compliance with the law of the Member State concerned, with due regard for the rights of the authorities concerned, and shall comply with the principle of proportionality. The Commission shall carry out its duties independently and impartially, and shall observe confidentiality in order to protect commercial secrets in accordance with the applicable law. The Commission shall bear the costs arising from such assessments.

4. The approval authorities concerned shall facilitate the assessment by cooperating with the Commission, giving it any necessary assistance and providing it with any necessary documentation.

5. The Commission shall ensure that the personnel participating in the assessment are sufficiently qualified and adequately instructed. The Commission shall, a sufficient time before the assessment, inform the Member States and the approval authorities concerned of the date on which the assessment is to begin and the identity of the personnel who are to carry out the assessment. The duration of the assessment at the premises of the approval authority concerned shall not normally exceed two days, and shall not in any case exceed three days.

6. Each approval authority that has granted at least one EU type-approval during a five year period shall be assessed by the Commission once during that period.

By way of derogation from the first subparagraph, the assessment of an approval authority may be less frequent if the Commission considers that the first assessment of that authority demonstrates that the procedures put in place ensure the effective application of this Regulation, taking into account the scope and range of EU type-approvals granted.

7. The Commission shall communicate the outcome of the assessment, including any recommendations, to the Forum and shall make a summary of the outcome publicly available. The Forum shall examine the outcome of the assessment.

8. The Member States shall report to the Commission and to the Forum on how they address any recommendations included in the outcome of the assessment.

9. Taking duly into account the considerations of the Forum, the Commission shall adopt implementing acts laying down common criteria for setting out the scope of, and the methodology used for, the assessment, the composition of the assessment team, the plan for the assessments covering a period of at least five years and the specific conditions under which the frequency of such assessments may be reduced. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 83(2).