MDR information for Point-It! Pro
This page provides information for resellers of the Point-It! Pro joystick in compliance with Medical Devices Regulation MDR 2017/745.
Classification
Class 1 Medical Device
Declaration of Conformity
Intended Use
The Point-It is a USB/HID compatible assistive device designed as an alternative to a standard mouse control. It compensates for poor hand function due to injury, impairment or disability by enabling a person to control a computer or smart device for the purposes of education, communication and/or environmental control.
Legal Manufacturer
Unique Perspectives Limited
Ballyline
Callan
Co. Kilkenny
IRELAND
EU
R95D9E8
Rep of Ireland Company Registration Number
286087
EUDAMED Single Registration Number (SRN)
Global Model Number (BUDI-DI/GMN)
Global Trade Identification Numbers (UDI-DI/GTIN)
5392000166233 – USB
5392000166264 – Bluetooth
Device Identification (placed on packaging)
(01) GTIN + (11) Production Date (YYMMDD) + (21) Device serial Number
Global Medical Device Nomenclature (GMDN)
Description: “Assistive mouse-control training device”
Code: 30967
European Medical Device Nomenclature (EMDN)
Description: “MOUSE AND KEYBOARD EMULATORS”
Code: Y210906
Rep. of Ireland Regulatory Authority:
Health Products Regulatory Authority (HPRA)
Earlsfort Centre
Dublin 2
HPRA Company Reference number
IE/CA01/M/GM/0501
HPRA Device Reference Number
IE/CA01/M/GM/0501/40421
Applied Standards
EN 55011: (2009) – E.M.C. requirements for Industrial, Scientific and Medical equipment.
EN 61000-6-1: (2005) – Electromagnetic compatibility (EMC)
User Manuals
http://housemate.ie/wp-content/uploads/2021/02/pointit_pro_user_manual_may_2021.pdf
Restrictions of the use of Hazardous Substances
Additional Information & reference documents
MEDDEV 2.7/1 (2016) – Guidelines on Medical Devices / Clinical Evaluation: A guide for manufacturers and Notified Bodies
MDCG 2020-5 (2020) – Clinical Evaluation – Equivalence: A guide for manufacturers and Notified Bodies
MEDDEV 2.4/1 (2010) – Guidelines for the classification of Medical Devices
ISO 13485 (2016) – Medical device – Quality management system – Requirements for regulatory purposes
ISO 14971 (2019) – Medical devices – Application of risk management to medical devices