21.B.20 Immediate reaction to a
safety problem
Regulation
(EU) 2022/203
(a) Without prejudice to Regulation (EU) No 376/2014 of the European Parliament and of the Council and its delegated and implementing acts, the competent authority shall implement a system to appropriately collect, analyse and disseminate safety information.
(b) The Agency shall implement a system to appropriately analyse any relevant safety information received and, without undue delay, provide the relevant authority of the Member States and the Commission with any information, including recommendations or corrective actions to be taken, that is necessary for them to react in a timely manner to a safety problem involving products, parts, appliances, persons or organisations that are subject to Regulation (EU) 2018/1139 and its delegated and implementing acts.
(c) Upon receiving the information referred to in points (a) and (b), the competent authority shall take adequate measures to address the safety problem.
(d) The competent authority shall immediately notify measures taken under point (c) to all persons or organisations which need to comply with them under Regulation (EU) 2018/1139 and its delegated and implementing acts. The competent authority of the Member State shall also notify those measures to the Agency and, when combined action is required, to the other Member States concerned.
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