ntr219-C_2022247EN.01000101-E0219
(219) In the field of medical devices, the manufacturer shall for implantable devices keep, the EU declaration of conformity available for the competent authorities for at least 15 years after the last device has been placed on the market (Article 10(8) 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.