art_32__para_8

8. Importers shall establish reporting channels and ensure that they are accessible to allow users to submit complaints, and shall keep a register of complaints, of non-conforming EHR systems and EHR system recalls and withdrawals. Importers shall verify whether the channels of complaint established pursuant to Article 30(1), point (n), are publicly available, allowing users to submit complaints and to receive any communication concerning any risk related to their health and safety or to other aspects of public interest protection and allowing users to be informed of any serious incident involving an EHR system. Where such channels of complaint were not established, the importers shall establish them and take into account the accessibility needs of vulnerable groups and persons with disabilities.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-15 · Text as adopted (Official Journal); later amendments are not incorporated in this text.