The Agency, to fulfil its tasks, shall operate a medical devices information system; this shall serve in particular to ensure the safety of medical devices, as well as vigilance and surveillance.
The information system shall contain data as specified in Article 62a which is necessary for the surveillance of medical devices and the conduct of notification and authorisation procedures for clinical trials in accordance with this Act.
The data referred to in paragraph 2 may be automatically aligned with Eudamed.
Any data referred to in paragraph 2 which is not sensitive may be published with due protection of professional confidentiality and trade secrets.
The Federal Council shall regulate:
the structure and data catalogue;
the access rights;
the organisational and technical measures necessary to ensure data protection and data security;
the storage period.
0 commentaries
No commentaries are available for this article yet.