Download g0004 Guide For Distributors of Medical Devices v1 PDF Free - Full Version
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About g0004 Guide For Distributors of Medical Devices v1
This document provides guidance for distributors of medical devices in Ireland on meeting their regulatory obligations. It outlines the key definitions, legislative basis, and obligations for distributors as defined in the new EU Medical Device and In Vitro Diagnostic Regulations. Distributors must act with due care when making devices available, maintain traceability records, and have a quality management system in place. They must cooperate with regulatory authorities and manufacturers to support vigilance activities including recalls if necessary. The document provides frameworks to help distributors meet these obligations and ensure the continued safety of medical devices.
Detailed Information
| Author: | ['Gelly Grace'] |
|---|---|
| Publication Year: | 2020 |
| Pages: | 29 |
| Language: | English |
| Format: | |
| Price: | FREE |
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