Property:RefPreview
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E
Damage compensation
1. Member States shall ensure that systems for compensation for any damage suffered by a subject resulting from participation i… +
I
Data Acquisition Tool (DAT)
A paper or electronic tool designed to collect data and associated metadata from a data originator in a clinical trial acc… +
Data Integrity
Data integrity includes the degree to which data fulfil key criteria of being attributable, legible, contemporaneous, original, accurat… +
E
Decision on the clinical trial
1. Each Member State concerned shall notify the sponsor through the EU portal as to whether the clinical trial is au… +
Decision on the substantial modification of aspects covered by Parts I and II of the assessment report
1. Each Member State concerned shall notify … +
Decision on the substantial modification of an aspect covered by Part I of the assessment report
1. Each Member State concerned shall notify the sp… +
Definition of ‘food’
For the purposes of this Regulation, ‘food’ (or ‘foodstuff’) means any substance or product, whether processed, partially proces… +
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 2 – 3 +
Definitions
(2) ‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit… +
Definitions
(10) ‘procedure pack’ means a combination of products packaged together and placed on the market with the purpose of being used for a spe… +
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 11 +
Definitions
(11) ‘kit’ means a set of components that are packaged together and intended to be used to perform a specific in vitro diagnostic examina… +
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 14 +
Definitions
(14) ‘instructions for use’ means the information provided by the manufacturer to inform the user of a device's intended purpose and prop… +
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 4 – 6 +
Definitions
(4) ‘accessory for an in vitro diagnostic medical device’ means an article which, whilst not being itself an in vitro diagnostic medical … +
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 42 +
Definitions
(42) ‘performance study’ means a study undertaken to establish or confirm the analytical or clinical performance of a device;… +
Definitions
(45) ‘clinical investigation’ means any systematic investigation involving one or more human subjects, undertaken to assess the safety or… +
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 45 +
Definitions
(45) ‘device for performance study’ means a device intended by the manufacturer to be used in a performance study.… +
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 58 +
Definitions
(58) ‘informed consent’ means a subject's free and voluntary expression of his or her willingness to participate in a particular performa… +
Definitions
(62) ‘recall’ means any measure aimed at achieving the return of a device that has already been made available to the end user;… +
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 7 – 9 +
Definitions
(7) ‘companion diagnostic’ means a device which is essential for the safe and effective use of a corresponding medicinal product to:
(a)… +
Definitions
For the purposes of this Regulation, the following definitions apply:
(1) ‘medical device’ means any instrument, apparatus, appliance, s… +
Definitions
For the purposes of this Regulation, the following definitions also apply:
(1) ‘Clinical study’ means any investigation in relation to h… +
