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Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Paragraph 3 – 4-002: Difference between revisions

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Paragraph 3 – 4
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|tags_display=[[Glossary:TAG-00201-Cli-eSt|Clinical investigation]], [[Glossary:TAG-00343-Doc-ten|Documentation]], [[Glossary:TAG-00063-Dat-per|Data protection]], [[Glossary:TAG-00017-Spo-die|Sponsor]], [[Glossary:TAG-00129-Dat-ali|Data integrity]]
 
|comment=Recording and retention of all clinical investigation information
{{:Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023}}
|content=Conduct of a clinical investigation
 
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! colspan="2" class="gplx-infobox-header" | Reference Details
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| Module 6 — Unit 6.3.1
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| MD
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! Document part
| Article 72
Paragraph 3 – 4
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! Language
| EN
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! Original entry by
| Florian Adragna
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! Contributors
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== Content ==
Conduct of a clinical investigation


3.  All clinical investigation 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.
3.  All clinical investigation 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.
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.
}}

Revision as of 12:56, 16 July 2026



Document information
Reference EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
Validity area EU
Scope(s) MD
Document name Regulation (EU) 2017/745 - Medical Device Regulation
Version / Revision 20-Mar-2023
Status Current
Document type Legal act
Language(s) EN
Description REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
Official source Official link
Restricted access No
Submitted by Florian Adragna
Contributors


Reference Details
Module Module 6 — Unit 6.3.1
Scope MD
Document part Article 72

Paragraph 3 – 4

Language EN
Original entry by Florian Adragna
Contributors
Tags Clinical investigation, Documentation, Data protection, Sponsor, Data integrity

Content

Conduct of a clinical investigation

3. All clinical investigation 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.

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