Manufacturer

The party a device regulation holds responsible for a device.

Where it is written

21 CFR 820.3(b); Regulation (EU) 2017/745, Article 2(30); Medical Devices Regulations (SOR/98-282), section 1

Also called

organization

Regimes

• Manufacturer (US)Any person who designs, makes, assembles, or processes a finished device. Under Part 820 the term also covers contract sterilization, installation, and relabeling. The term extends to remanufacturers, repackers, specification developers, and initial distributors of foreign entities.
• Manufacturer (EU)A natural or legal person who manufactures or fully refurbishes a device, or has one designed, manufactured, or fully refurbished, and markets it under its own name or trade mark.
• Manufacturer (CA)A person who sells a medical device under their own name or a mark they own or control, and who is responsible for designing, manufacturing, assembling, processing, labeling, packaging, refurbishing, or modifying it, or for assigning it a purpose. The person may perform those tasks or have others perform them.

Related terms