Manufacturer (of a medical device)
Short definition
A manufacturer, under Regulation (EU) 2017/745, is the natural or legal person who manufactures or fully refurbishes a device, or has a device designed or manufactured, and markets it under its own name or trademark.
In plain language
The definition is in Article 2, point 30, of the MDR, and its obligations in Article 10. The manufacturer is responsible for the device's conformity: risk management, clinical evaluation, technical documentation, quality management system, post-market surveillance and reporting of serious incidents. The legal manufacturer may not be the party that physically produces the equipment.