Articles of the European Health Data Space (EHDS), Article 30, Handling of non-compliance



Article 30, Handling of non-compliance, Articles of the European Health Data Space (EHDS), (Proposal_3.5.2022)

1. Where a market surveillance authority makes one of the following findings, it shall require the manufacturer of the EHR system concerned, its authorised representative and all other relevant economic operators to put an end to the non-compliance concerned:

(a) the EHR system is not in conformity with essential requirements laid down in Annex II;

(b) the technical documentation is either not available or not complete;

(c) the EU declaration of conformity has not been drawn up or has not been drawn up correctly;

(d) the CE marking has been affixed in violation of Article 27 or has not been affixed.


2. Where the non-compliance referred to in paragraph 1 persists, the Member State concerned shall take all appropriate measures to restrict or prohibit the EHR system being placed on the market or ensure that it is recalled or withdrawn from the market.