Article 18 Documentation keeping

1. the technical documentation referred to in Article 11;

2. the documentation concerning the quality management system referred to in Article 17;

3. the documentation concerning the changes approved by notified bodies means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation;, where applicable;

4. the decisions and other documents issued by the notified bodies means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation;, where applicable;

5. the EU declaration of conformity referred to in Article 47.

Each Member State shall determine conditions under which the documentation referred to in paragraph 1 remains at the disposal of the national competent authoritiesas defined in Article 46 for the period indicated in that paragraph for the cases when a provider or its authorised representative means a natural or legal person established within the Union who has received a written mandate from a manufacturer to act on its behalf in relation to specified tasks; established on its territory goes bankrupt or ceases its activity prior to the end of that period.

Providers that are financial institutions subject to requirements regarding their internal governance, arrangements or processes under Union financial services law shall maintain the technical documentation as part of the documentation kept under the relevant Union financial services law.