Introduction
ZP is the world's only contract developer and manufacturer of electrochemical biosensors who upon agreement with the client and collaborator is able to take on the responsibilites as the legal manufacturer of a medical diagnostic product.
In accordance with the Medical Devices Regulation (EU) 2017/745, a manufacturer is defined as:
“A natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark.”
When ZP takes on the role of legal manufacturer it also means, that ZP will, in partnership with the client/collaborates, ZP will
- ZP with the client establishes, documents, implement and maintains a system for risk management.
- ZP with the client conducts a clinical evaluation of the medical device.
- ZP with the client draws up the Technical Documentation and keeping it up to date.
- ZP with the client draws up the EU Declaration of Conformity and affixing the CE mark, inline with the IVDR.
- ZP with the client seeks FDA clearance/510 k status etc.
- ZP if assigned the legal manufacturer status will retain documents, which shall be kept available for the competent authorities for at least 10 years, 15 years for implantable devices.
- ZP if assigned the legal manufacturer status ensures that procedures are in place to keep series production in conformity with the legal requirements.
- ZP if assigned the legal manufacturer status will implement a post-market surveillance system an keep it up to date.
- ZP if assigned the legal manufacturer status ensures that the device is accompanied by the appropriate information, e.g. instructions.
- ZP if assigned the legal manufacturer status ensures the necessary corrective actions when the manufacturer has reason to believe that a device that they have placed onto the US/European market or put into service is not in conformity with the legal requirements.
- ZP if assigned the legal manufacturer status will implement a system for the recording and reporting of incidents and field safety corrective actions.
- ZP if assigned the legal manufacturer status will have measures in place regarding financial coverage for potential liability as natural or legal persons may claim compensation for damage caused by a defective device.
Conclusion
It is important to keep in mind that if ZP becomes your legal manufacturer then we will have the responsibility for bringing a product onto the US/European market which is fully compliant with the legal requirements. Therefore, the manufacturer shall ensure that all obligations have been met.