Description
This document is a checklist (Word template) for the Essential Principles (EP) under the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (IVDD).
Features
- Fully implementable for a paper-based or a electronic Quality Management System (QMS)
- Customisable without restrictions (parts highlighted in yellow help you to know where to customise the document)
- Compliant with ISO 13485:2016
- Tested and approved several times in EU medical devices companies
41 pages
Template version: 1.0
Table of Content
A. General Requirements
B. Design and Manufacturing Requirements
- Chemical and physical properties
- Infection and microbial contamination
- Manufacturing and environmental properties
- Devices which are instruments or apparatus with a measuring function
- Protection against radiation
- Requirements for medical devices connected to or equipped with an energy source
- Requirements for devices for self-testing
- Information supplied by the manufacturer
Sample:
