Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 3 – 4-002

Document information
Reference	EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023
Validity area	EU
Scope(s)	IVD
Document name	Regulation (EU) 2017/746 - in vitro diagnostic medical devices
Version / Revision	20-Mar-2023
Status	Current
Document type	Legal act
Language(s)	EN
Description	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
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Scope	IVD
Document part	Article 68 Paragraph 3 – 4
Language	EN
Original entry by	Florian Adragna
Contributors
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Tags (FR)
Comment	Repeated entry: 4.2.5 ++ 6.3.1 Recording, processing, handling and storage of performance study information (repeated)

Content

Conduct of a performance study

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.