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User Manual
May 2021
©Unique Perspectives
www.click2go.ie
Page 14 of 14
10 CE Marking
Point-It! is marketed as a technical aid for people with disabilities and satisfies
the requirements of Medical Devices Regulation MDR 2017/745.
Point-It! is classified as a Class 1 medical device.
The following international standards have been applied:
EN ISO 14971 – Medical devices – Application of risk management to medical
devices.
MEDDEV 2.7.1 – Guidelines on Medical Devices / Clinical Evaluation: A guide
for manufacturers and Notified Bodies
EN ISO 13485 – Medical device – Quality management system – Requirements
for regulatory purposes
EN60601-1-2: 2011
EN 55016-2-3 (2010) & A1 (2010) - Emissions
EN61000-4-2 (2009) – Electrostatic discharge
EN61000-4-3 (2006) – Immunity
R&TTE Directive 1999/5/EC