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EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 1 +
Conduct of a performance study
1. The sponsor and the investigator shall ensure that the performance study is conducted in accordance with the appr… +
Conduct of a performance study
1. The sponsor and the investigator shall ensure that the performance study is conducted in accordance with the appr… +
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 2 +
Conduct of a performance study
2. In order to verify that the rights, safety and well-being of subjects are protected, that the reported data are r… +
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 3 – 4-001 +
Conduct of a performance study
3. All performance study information shall be recorded, processed, handled, and stored by the sponsor or investigato… +
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 3 – 4-002 +
Conduct of a performance study
3. All performance study information shall be recorded, processed, handled, and stored by the sponsor or investigato… +
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 5 +
Conduct of a performance study
5. Member States shall inspect, at an appropriate level, performance study site(s) to check that performance studies… +
Confidentiality
1. Unless otherwise provided for in this Regulation and without prejudice to existing national provisions and practices in the Memb… +
Confidentiality
1. Unless otherwise provided for in this Regulation and without prejudice to existing national provisions and practices in the Memb… +
Conformity assessment procedures
1. Prior to placing a device on the market, manufacturers shall undertake an assessment of the conformity of that … +
Conformity assessment procedures
1. Prior to placing a device on the market, manufacturers shall undertake an assessment of the conformity of that … +
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Consideration in identifying critical to quality factors
[…]
The eligibility criteria should be reflective of the study objectives and be well documen… +
Contract Research Organisation (CRO)
See Service Provider.… +
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Corrective measures to be taken by Member States
1. Where a Member State concerned has justified grounds for considering that the requirements set … +
Corrective measures to be taken by Member States and information exchange between Member States
1. Where a Member State in which a clinical investi… +
Corrective measures to be taken by Member States and information exchange between Member States
3. Where a Member State has taken a measure referre… +
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GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D Who should notify +
D. Arrangements for notification
Who should notify?
The Sponsor or a person legally authorised by the Sponsor to perform this function (for example, a… +
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EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter II Section 1.7 +
DOCUMENTATION REGARDING THE APPLICATION FOR CLINICAL INVESTIGATION
For investigational devices covered by Article 62, the sponsor shall draw up and s… +
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter I Section 1.8 +
DOCUMENTATION REGARDING THE APPLICATION FOR INTERVENTIONAL CLINICAL PERFORMANCE STUDIES AND OTHER PERFORMANCE STUDIES INVOLVING RISKS FOR THE SUBJECTS… +
Damage compensation
1. Member States shall ensure that systems for compensation for any damage suffered by a subject resulting from participation i… +
Damage compensation
1. Member States shall ensure that systems for compensation for any damage suffered by a subject resulting from participation i… +
