Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 109 Paragraph 1-002

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
Scope	MD
Document part	Article 109 Paragraph 1
Language	EN
Original entry by	Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment	Repeated entry: 4.5.1 ++ 4.5.2 Confidentiality of clinical investigation information (MDR)

Content

Confidentiality

1. Unless otherwise provided for in this Regulation and without prejudice to existing national provisions and practices in the Member States on confidentiality, all parties involved in the application of this Regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the following:

(a) personal data, in accordance with Article 110;

(b) commercially confidential information and trade secrets of a natural or legal person, including intellectual property rights; unless disclosure is in the public interest;

(c) the effective implementation of this Regulation, in particular for the purpose of inspections, investigations or audits.