Legal Manufacturer
A legal manufacturer for a medical device is the entity (company, organization, or individual) legally responsible for the design, production, packaging, labeling, and market release of the device, ensuring it complies with applicable regulatory requirements. This term is commonly used in regulatory frameworks like the EU Medical Device Regulation (MDR) or FDA regulations in the U.S.
Key responsibilities of a Legal Manufacturer
- Ensuring the device meets safety, performance, and quality standards.
- Maintaining technical documentation and labeling in compliance with regulations.
- Registering the device with relevant authorities (e.g., FDA, EU competent authorities).
- Implementing a quality management system (e.g., ISO 13485).
- Reporting adverse events or recalls to regulatory bodies.
- Holding liability for the device's safety and performance.
The legal manufacturer is typically named on the device’s labeling and may or may not be the actual physical manufacturer (e.g., if production is outsourced). In cases of outsourcing, the legal manufacturer retains ultimate responsibility for compliance and safety.
For example: In the EU, under MDR, the legal manufacturer is the "manufacturer" defined in Article 2(30) and is responsible for the conformity assessment. In the U.S., the FDA refers to this entity as the "manufacturer" under 21 CFR Part 820, responsible for registering and listing the device.
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