ntr294-C_2022247EN.01000101-E0295
(294) Unless the EU Declaration of Conformity is required to accompany the product, in which case the distributor should provide the market surveillance authorities with such document. In the field of medical devices, the competent authorities may require distributors to, make available the documentation and information necessary for the purpose of carrying out the authorities’ market surveillance activities (Article 93(2) of Regulation 2017/745).
Source: EUR-Lex (Cellar) · retrieved 2026-09-25 · Text as adopted (Official Journal); later amendments are not incorporated in this text.