Manufacturer
Manufacturer is defined under MDR (EU) 2017/745 Art. 2(30) as the natural or legal person who manufactures or fully refurbishes a device, or who has a device designed, manufactured, or fully refurbished and markets it under their name or trademark.
Manufacturer obligations under MDR:
- Carry out the conformity assessment and affix CE marking
- Issue and retain the EU Declaration of Conformity
- Draw up and keep current the technical documentation
- Operate a quality management system (EN ISO 13485)
- Maintain a post-market surveillance system
- Report incidents and field safety corrective actions (FSCA)
- Implement the UDI system and make EUDAMED entries
Manufacturers outside the EU: can only place medical devices on the EU market through an EU Authorised Representative. The Authorised Representative takes on specific obligations, but primary responsibility remains with the manufacturer.
Distinctions:
- Importer: places products from third countries onto the EEA market
- Distributor: makes products available within the EEA
- Contract manufacturer: produces on behalf of the manufacturer but bears no regulatory responsibility
Frequently asked questions
Who qualifies as a manufacturer under MDR?
Whoever markets a product under their own name or trademark qualifies as the manufacturer - regardless of whether they produce it themselves. Anyone distributing a third-party product under their own name becomes the manufacturer and assumes all manufacturer obligations.
What is the difference between manufacturer and importer?
Manufacturer: responsible for product conformity, CE marking, technical documentation, PMS. Importer: ensures the non-EU manufacturer has fulfilled their obligations; places the product on the EEA market. The importer verifies but is not primarily liable for product conformity.
Must the manufacturer be based in the EU?
No. The manufacturer may be based anywhere in the world. If located outside the EU, they must designate an EU Authorised Representative who assumes some manufacturer obligations towards EU authorities.