# Legal manufacturer ISO 13485: EU MDR class I to IIb | INOPREX

> INOPREX is a legal manufacturer of medical devices under EU MDR (non-active, class I, IIa, IIb) with a QMS under ISO 13485:2016 in progress: technical documentation, risk management under ISO 14971, EUDAMED, vigilance and PMS.

Quelle: https://inoporex.de/en/leistungen/legalhersteller-iso-13485/

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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.

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 14971 · Regulation (EU) 2017/745 (MDR) · EN ISO 15223-1:2021