Self Assessment Pack for Class 1 Medical Face Masks (with 2 hours of support time)


 Compliance assistance package for supply of face masks in response to the Covid-19 crisis.

This pack is intended to help producers of medical face masks worn by clinical staff to reduce the spread of infections or virus.  These are Class 1 medical products under the Medical Devices Regulation (EU) 2017/745.  It only considers the medical aspects; use as Personal Protective Equipment (PPE) is not considered.

 The pack contains:

• Comprehensive guidance notes which take you through the self certification compliance process
• Checklist for EN 14683:2019
• Checklist for the Essential Health and Safety Requirements of Annex I of the MDR and a Risk Management plan
• A statement for the clinical evaluation of medical face masks 
• Checklist for the production Quality Control issues
• Checklist for product marking, packaging information and user instructions
• Procedure for contacting MHRA. 
• Clinical evaluation template
• Content list for technical documentation
• Template for manufacturer’s EU Declaration of Conformity 
• Checklist for post-production feedback
• Up to 2 hours telephone/e-mail support (1st hour to explain the pack and its contents, 2nd hour to privide support). 

Face masks require testing before they can be placed on the market. This pack provides a step-by-step guide to meeting the requirements, including the tests you need to carry out and the evidence you will need to produce and keep. However, because of the complexity of the required tests, you should engage a suitable test body to perform them. Details of suitable companies who can do the tests are contained in the pack.

The pack includes two hours of consultancy time. More consultancy time can be purchased through our web shop, if required.

If you would like more information we have written an article on CE Marking for masks and face shields used for protection against Covid-19

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 (total cost is £900).
  • 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. 

Conformance Offices

Head Office

Great Hucklow
SK17 8RG
United Kingdom

Tel: +44 (0)1298 873800
Fax: +44 (0)1298 873801
E-mail: cemark[at]

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