CE Declaration of Conformity
Bastion House, 6th Floor
140 London Wall
London EC2Y 5DN
Name of Device:
Physitrack Software Platform
Class: I (according to Medical Devices Directive (93/42/EEC)
Conformity Assessment Route:
Physitrack PLC applied the procedures for the CE-labelling of the product in accordance with the Council Directive 93/42 (EEC) and Medical Devices Regulation (EU) 2017/745
Self-care monitoring/reporting software - 58884
We hereby declare that the medical device (Software) specified above meets the provisions of the Council Directive No. 93/42/EEC for Medical Devices and issued under the sole responsibility of Physitrack PLC.
The Software as medical device covered by the present EU declaration is in conformity with the (EU) MDR 2017/745.
All supporting documentation for this EC Declaration of Conformity is retained in the document management system of the manufacturer.
Chief Compliance Officer