What exactly does legal manufacturer mean?

The legal manufacturer is the person who places the medical device on the market under their own name — regardless of who physically manufactures it. They bear full responsibility under EU MDR: conformity, documentation, labelling, vigilance.

Which classes does INOPREX cover?

Non-active medical devices class I, IIa and IIb. For class IIa and IIb, conformity assessment runs via a notified body; class I (except Is/Im/Ir special routes) does not.

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Legal manufacturer for medical devices under ISO 13485

INOPREX is the legal manufacturer for non-active medical devices class I, IIa and IIb under EU MDR — with a QMS under ISO 13485:2016 in progress, certification initiated, and full responsibility for documentation and market access.

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A legal manufacturer is the natural or legal person who places a medical device on the market under their own name and bears full responsibility under EU MDR. INOPREX takes on this role for non-active medical devices class I, IIa and IIb: QMS under ISO 13485:2016 in progress, certification initiated, technical documentation, risk management under ISO 14971, clinical evaluation, EUDAMED and UDI, vigilance, PMS and PMCF, plus communication with notified bodies and authorities.

Our QMS under ISO 13485:2016 is currently being established; certification has been initiated. We will share the current status transparently within your project.

Obligations INOPREX takes on as legal manufacturer

QMS under ISO 13485:2016 in progress (certification initiated), risk management under ISO 14971
Technical documentation per Annexes II and III of Regulation (EU) 2017/745 (MDR)
Classification per MDR Annex VIII and conformity assessment
Labelling per EN ISO 15223-1:2021, UDI and EUDAMED registration
Clinical evaluation, post-market surveillance and PMCF
Vigilance, complaint and CAPA management
Communication with notified bodies and authorities

Scope

Covered: non-active medical devices class I, IIa and IIb. Not covered: active and electro-medical devices, apparatus, implants, IVDs and software as a medical device.

Beyond medical devices, INOPREX takes on the roles of responsible person under Regulation (EC) No 1223/2009 for cosmetics and of the food business operator placing products on the market for supplements.

ISO 13485:2016 (certification in progress)ISO 14971Regulation (EU) 2017/745 (MDR)EN ISO 15223-1:2021