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Regulation (EU) 2017/746 of the European Parliament and of the CouncilDangos y teitl llawn

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)

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Article 68Conduct of a performance study

1.The sponsor and the investigator shall ensure that the performance study is conducted in accordance with the approved performance study plan.

2.In order to verify that the rights, safety and well-being of subjects are protected, that the reported data are reliable and robust, and that the conduct of the performance study is in compliance with the requirements of this Regulation, the sponsor shall ensure adequate monitoring of the conduct of a performance study. The extent and nature of the monitoring shall be determined by the sponsor on the basis of an assessment that takes into consideration all characteristics of the performance study including the following:

(a)the objective and methodology of the performance study; and

(b)the degree of deviation of the intervention from normal clinical practice.

3.All performance study information shall be recorded, processed, handled, and stored by the sponsor or investigator, as applicable, in such a way that it can be accurately reported, interpreted and verified while the confidentiality of records and the personal data of the subjects remain protected in accordance with the applicable law on personal data protection.

4.Appropriate technical and organisational measures shall be implemented to protect information and personal data processed against unauthorised or unlawful access, disclosure, dissemination, alteration, or destruction or accidental loss, in particular where the processing involves transmission over a network.

5.Member States shall inspect, at an appropriate level, performance study site(s) to check that performance studies are conducted in accordance with the requirements of this Regulation and with the approved investigation plan.

6.The sponsor shall establish a procedure for emergency situations which enables the immediate identification and, where necessary, an immediate recall of the devices used in the study.

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