Knowledge · Legal manufacturer
Legal manufacturer: meaning, obligations, responsibility
Definition and obligations of the legal manufacturer under EU MDR — and what INOPREX takes on in this role.
A legal manufacturer is the natural or legal person who places a medical device on the market under their own name — regardless of who physically designed or manufactured it. The legal manufacturer bears full responsibility for conformity under EU MDR and owes technical documentation, labelling, vigilance and post-market surveillance.
Definition under EU MDR
Article 13 of Regulation (EU) 2017/745 (MDR) defines the obligations of manufacturers: the manufacturer is the person who manufactures a device or has it designed and manufactured and markets it under their own name. Role and responsibility are decisive, not the machine park.
Core obligations of the legal manufacturer
- QMS under ISO 13485:2016 in progress (certification initiated) and risk management under ISO 14971
- Technical documentation per Annexes II and III of the MDR
- Conformity assessment and CE marking
- Labelling per EN ISO 15223-1:2021, UDI and EUDAMED registration
- Vigilance and reporting, post-market surveillance and PMCF
- Field safety corrective actions and traceability
What INOPREX takes on
INOPREX acts as the legal manufacturer in client projects: formulation and specification, technical documentation, classification, notified body procedures, EUDAMED and labelling from a single source. The client runs the brand and distribution.
Frequently asked questions
Can a legal manufacturer exist without their own factory?
Yes. The MDR ties the manufacturer role to responsibility, not to owning production lines. INOPREX works with qualified contract manufacturers and fillers in the EU and remains the responsible manufacturer in the project.
What happens in case of an incident (vigilance)?
The manufacturer must assess incidents, report to authorities where required and initiate corrective measures. As legal manufacturer we run this reporting procedure including documentation.
Applied to your project
We apply these rules directly to your project — from classification to market access. First assessment within two working days.