MDR - Annex VII - article 1.3

Original text

Expert opinion


1.3.1. The notified body shall have documented procedures in place ensuring that its personnel, committees, subsidiaries, subcontractors, and any associated body or personnel of external bodies respect the confidentiality of the information which comes into its possession during the performance of conformity assessment activities, except when disclosure is required by law.



The Notfied Body (NB) is bound to confidentiality by the Medical Device Regulation MDR 2017/745. The regulation actually extends the confidentiality to subcontracted and associated bodies and natural persons of the NB. So, any freelance auditor, reviewer or other collaborator is included and no additional confidential disclosure agreement (CDA) has to be established between the company and the person acting on behalf of the NB.


1.3.2. The personnel of a notified body shall observe professional secrecy in carrying out their tasks under this Regulation or any provision of national law giving effect to it, except in relation to the authorities responsible for notified bodies, competent authorities for medical devices in the Member States or the Commission. Proprietary rights shall be protected. The notified body shall have documented procedures in place in respect of the requirements of this Section.

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