Medical  Device  &  QA  Consultancy

OWN BRAND LABELING or OWN BRANDING or PRIVATE LABELING of Medical Devices....

DEFINITIONS:

Own Branding or Private Labeling is where already CE Marked Medical Devices are Placed on the Market by a Third Party body.

The Third Party body is referred to as the OWN BRANDER.

The original body who CE Marked the Products is known as the ORIGINAL EQUIPMENT MANUFACTURER or OEM.

Medical Device & QA Consultancy offers a Professional and Least Effort Approach to meeting all the Regulatory Requirements for a Fixed Minimum Cost.  

Contact us for help in Own Brand Labeling issues.......by filling out the Form, or e-mail us at:

info@mdqa.co.uk

MAIN REQUIREMENTS:

Because the OEM will normally have compiled a Technical File to demonstrate compliance with the requirements of the Medical Device Directive, the work and effort does not have to be repeated. The following are some of the issues that have to be addressed;