This downloadable pack contains the information required for you to understand the process of CE marking Class 1 Medical Devices.
Self-Assessment Procedure for Class 1 Medical Devices
1. Is this product suitable for me?
1.1. This product suits your needs if:
• You are a manufacturer of Class 1 Medical Devices;
• The device is not ‘sterile’;
• The device does not contain a ‘measuring function’;
• You are based in the European Community;
• You need guidance regarding the procedure to follow before CE marking your product under the Medical Devices Directive 93/42/EEC.
1.2 The Directive requires all medical devices to be designed and built to provide appropriate protection from all hazards and to ensure that they deliver the medical benefits claimed for them.
1.3 This procedure explains how to prepare the documentation to demonstrate this.
Please see our web page at the following address for more details:
2. Self-Assessment Package
2.1. The Self Assessment package comprises of two items:
• Two hours assistance
• Checklists and Templates
2.2. Two hours assistance (consultancy time must be used within 12 months from purchase date)
One of our Medical Devices Consultants will provide you with assistance. This is usually provided over the phone, or through online-hosted meetings.
If you prefer, you can also book a visit at our premises.
We suggest you to use this time once you have finished your technical file; you will have a list of questions and doubts and this is the best time to discuss all of them with Conformance.
2.3. Checklists and Templates
The package includes the following:
• Medical Device classification checklist
• Essential Health and Safety Requirements checklist
• Technical documentation checklist
• EN 980 checklist
• Draft Declaration of Conformity
• EN 14971 checklist
• Risk management format
• Vigilance format
• EN ISO 13485 checklist
• QMS for Class 1 (14D0355)
Please note -
- Once you purchase the pack, you will receive two emails, the second one containing a link to download the pack. The download link will only remain active for 3 days so please make sure you download the pack and save to your computer before this time.
- The download is a compressed ZIP format and you will need to 'unzip' the file to see the Word and PDF documents contained.
- Consultancy time must be used within 12 months from purchase date.
- VAT will be added at the checkout.
- All rights reserved. No part of this document is to be re-sold, reproduced or transmitted in any form or by any means, electronic or mechanical, without prior written consent from Conformance Limited.