1st April 2017 - This product is currently under review, in order to be aligned with the MHRA guidance "Virtual Manufacturing replaces Own Brand Labelling for medical device manufacturers" Version 1.0 March 2017. To view this document please click here. For more information please contact us.
To help you decide if this is the right product for you, please click here to download the flowchart "Am I an OBL?" With a few simple questions, you can clarify if you are taking on the role of an OBL or if instead, you are an importer, a distributor or an Authorised Representative.
The Conformance OBL (Own Brand Labelling) pack is designed to guide you through the work that you have to complete before placing a medical device on the EEA market, under your own name. It covers both the technical and legal aspects of compliance and includes many examples, which makes it easy to follow.
This pack contains:
Checklist and templates
2 hours of support for answering your questions as you work through the pack, (support time must be used within 12 months from purchase date)
A previous knowledge of the Medical Devices Directive is not necessary for completion of this pack, but if no prior knowledge is available we would recommend potential customers to, visit our MDD webpages or to contact ourselves for further training and consultancy services.
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.