Guide for Custom-Made Dental Device Manufacturers on Compliance with European Communities (Medical Devices) Regulations, 1994 – Ireland  

Article No. 42421

Description

This guidance document provides a general overview of requirements for manufacturers of typical custom-made dental devices.

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Synopsis

Manufacturers of custom-made medical devices in Ireland must register their custom-made medical devices and registered address with the Health Products Regulatory Authority.

Manufacturers of custom-made devices do not have to place the CE mark on such devices.

Each finished device should be accompanied by information supplied by the manufacturer to use and maintain the device properly, taking into account the training and knowledge of potential users.