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Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance. ) article 72 CELEX: 02017R0746-20250110 Corrective measures to be taken by Member States and information exchange between Member States on performance studies
1. Where a Member State in which a performance study is being or is to be conducted has grounds for considering that the requirements set out in this Regulation are not met, it may take at least any of the following measures on its territory: (a) revoke the authorisation for the performance study; (b) suspend or terminate the performance study; (c) require the sponsor to modify any aspect of the performance study. 2. Before the Member State concerned takes any of the measures referred to in paragraph 1 it shall, except where immediate action is required, ask the sponsor or the investigator or both for their opinion. That opinion shall be delivered within seven days. |
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance. ) article 72 CELEX: 02017R0746-20250110 3. Where a Member State has taken a measure referred to in paragraph 1 of this Article, or has refused a performance study, or has been notified by the sponsor of the early termination of a performance study on safety grounds, that Member State shall communicate the corresponding decision and the grounds therefor to all Member States and the Commission by means of the electronic system referred to in Article 69. 4. Where an application is withdrawn by the sponsor prior to a decision by a Member State, that information shall be made available through the electronic system referred to in Article 69 to all Member States and the Commission. |