Unless otherwise established by the delegated acts referred to in Article 19, organisations responsible for the design and production of products, parts and non-installed equipment shall be subject to certification and shall be issued with an approval. That approval shall be issued upon application, when the applicant has demonstrated that it complies with the rules established by the delegated acts referred to in Article 19 for ensuring compliance with the essential requirements referred to in Article 9. That approval shall specify the privileges granted to the organisation and the scope of the approval.

The approvals referred to in paragraph 2 of this Article shall specify the privileges granted to the organisation. Those approvals may be amended to add or remove privileges, in accordance with the implementing acts referred to in point (b) of Article 17(1).

The approvals referred to in paragraph 2 of this Article may be limited, suspended or revoked when the holder no longer complies with the rules and procedures for issuing and maintaining such approval, in accordance with the implementing acts referred to in point (b) of Article 17(1).

When as a result of the adoption of the implementing acts referred to in point (b) of Article 17(1), taking into account the objectives and principles set out in Articles 1 and 4, and in particular the nature and risk of the activity concerned, an approval referred to in paragraph 2 of this Article is not required, implementing acts referred to in Article 17 may still require the organisation concerned to declare its capability, and the availability to it of the means, to discharge its responsibilities associated with the activities that it performs in compliance with those implementing acts.