Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)

• Date: October 05, 2009
• Source: www.ghtf.org

This document is intended to provide guidance on the content of the STED to be assembled and submitted to a RA or CAB for premarket review, and for use post-market to assess continuing conformity to the Essential Principles of Safety and Performance.

The availability of such Summary Technical Documentation (STED) should help eliminate differences in documentation requirements between jurisdictions, thus decreasing the cost of gaining regulatory compliance and allowing patients earlier access to new technologies and treatments.

Major Sections of this document

6.0 Device Description and Product Specification, Including Variants and Accessories
6.1 Device Description
6.2 Product Specification
6.3 Reference to similar and previous generations of the device
7.0 Labelling
8.0 Design and Manufacturing Information
    8.1 Device Design
    8.2 Manufacturing Processes
    8.3 Design and Manufacturing Sites
9.0 Essential Principles (EP) Checklist
10.0 Risk Analysis and Control Summary
11.0 Product Verification and Validation
    11.1 General
    11.2 Biocompatibility
    11.3 Medicinal Substances
    11.4 Biological Safety
    11.5 Sterilisation
    11.6 Software Verification and Validation
    11.7 Animal Studies
    11.8 Clinical Evidence
12.0 Format of the STED
13.0 Declaration of Conformity

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