Private labelling is a much used phenomenon in the medical device industry. Private labelling means to bring a product from another manufacturer onto the European market under your own brand name.
When you are bringing a medical device onto the European market under your own name, you are the legal manufacturer. This means that you have the sole responsibility to ensure compliance of the medical device with the applicable legislation.
Obligations legal manufacturer
Examples of the obligation that lay with the legal manufacturer are:
- Ensure the medical devices have been designed and manufactured in accordance with the applicable legislation.
- Conducting a clinical evaluation.
- Drawing up and keeping up to date of Technical Documentation.
- Drawing up the EU Declaration of Conformity and affix the CE marking.
- Retention of documentation.
- Implement a Quality Management System.
Are you a private label manufacturer or are you planning on being a private label manufacturer? CE Medical can assist you in every step of the way. CE Medical can assist you with:
- Determining the suitability of your supplier.
This service consists of reviewing the supplier as to determine whether the supplier complies with the applicable legislation.
- Drawing up of the technical agreement.
The private label manufacturer and the supplier should have a written contract which indicates the responsibilities and obligations of both parties.
- Drawing up of Technical Documentation.
The supplier already has his Technical Documentation of the medical device. Additional to the Technical Documentation of the supplier, the private label manufacturer shall also draw up specific documentation, e.g. Instructions For Use, Labels, product lists etc.
- Implementation of a suitable Quality Management System.
The supplier often already has a certified Quality Management System. However, even if you are not repacking the medical devices and you just store and ship the medical devices, you shall have implemented a suitable Quality Management System.
- Guidance through the assessment procedure of a Notified Body.
As legal manufacturer, you shall lodge an application for an assessment procedure with a Notified Body. CE Medical will guide you through this procedure.