1.When a Member State designates a technical service, the latter shall comply with the provisions of this Directive.
2.The technical services shall carry out themselves or supervise the tests required for approval or inspections specified in this Directive or in a regulatory act listed in Annex IV, except where alternative procedures are specifically permitted. They may not conduct tests or inspections for which they have not been duly designated.
3.The technical services shall fall into one or more of the four following categories of activities, depending on their field of competence:
(a)category A, technical services which carry out in their own facilities the tests referred to in this Directive and in the regulatory acts listed in Annex IV;
(b)category B, technical services which supervise the tests referred to in this Directive and in the regulatory acts listed in Annex IV, performed in the manufacturer’s facilities or in the facilities of a third party;
(c)category C, technical services which assess and monitor on a regular basis the manufacturer’s procedures for controlling conformity of production;
(d)category D, technical services which supervise or perform tests or inspections in the framework of the surveillance of conformity of production.
4.Technical services shall demonstrate appropriate skills, specific technical knowledge and proven experience in the specific fields covered by this Directive and the regulatory acts listed in Annex IV.
In addition, technical services shall comply with the standards listed in Appendix 1 to Annex V which are relevant for the activities they carry out. However, this requirement does not apply for the purposes of the last stage of a multi-stage type-approval procedure as referred to in Article 25(1).
5.An approval authority may act as a technical service for one or more of the activities referred to in paragraph 3.
6.A manufacturer or a subcontracting party acting on his behalf may be designated as a technical service for category A activities with regard to the regulatory acts listed in Annex XV.
The Commission shall amend the list of these regulatory acts where necessary in accordance with the regulatory procedure with scrutiny referred to in Article 40(2).
7.The entities referred to in paragraphs 5 and 6 shall comply with the provisions of this Article.
8.Technical services, other than those designated in accordance with paragraph 6, of a third country may be notified for the purposes of Article 43 only in the framework of a bilateral agreement between the Community and the third country in question.
1.The skills referred to in Article 41 shall be demonstrated by an assessment report established by a competent authority. This may include a certificate of accreditation issued by an accreditation body.
2.The assessment on which the report referred to in paragraph 1 is based shall be conducted in accordance with the provisions of Appendix 2 to Annex V.
The assessment report shall be reviewed after a maximum period of three years.
3.The assessment report shall be communicated to the Commission upon request.
4.The approval authority which acts as a technical service shall demonstrate compliance through documentary evidence.
This includes an assessment conducted by auditors independent of the activity being assessed. Such auditors may be from within the same organisation provided that they are managed autonomously from personnel undertaking the assessed activity.
5.A manufacturer or a subcontracting party acting on his behalf, designated as a technical service, shall comply with the relevant provisions of this Article.
1.Member States shall notify to the Commission the name, the address including electronic address, the responsible persons and the category of activities with respect to each designated technical service. They shall notify it of any subsequent modifications thereto.
The notification act shall state in respect of which regulatory acts the technical services have been designated.
2.A technical service may conduct the activities described in Article 41 for the purposes of type-approval only if it has been notified beforehand to the Commission.
3.The same technical service may be designated and notified by several Member States irrespective of the category of activities which it conducts.
4.Where a specific organisation or competent body, the activity of which is not included in those referred to in Article 41, needs to be designated in application of a regulatory act, the notification shall be made in accordance with the provisions of this Article.
5.The Commission shall publish a list and details regarding the approval authorities and technical services on its web-site.