# Knowledge: legal manufacturer, EU MDR, ISO 13485, PIF & more | INOPREX

> Glossary and knowledge base from INOPREX: legal manufacturer, contract manufacturer vs. filler, private vs. white label, ISO 13485, EU MDR classification, MDR Article 16, technical documentation, PIF and CPNP, UDI and EUDAMED, PRRC, claims, MOQ, borderline products.

Quelle: https://inoporex.de/en/wissen/

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## Glossary and knowledge base

Terms, standards and procedures around medical devices, cosmetics and food supplements — explained factually and citably.

The INOPREX knowledge base explains the key terms of the industry: legal manufacturer, EU MDR, ISO 13485, PIF, CPNP, UDI, EUDAMED, PRRC, claims, MOQ and borderline classification. Each article is its own indexable page with an FAQ block.

- **Legal manufacturer** — 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. Definition, obligations and distinction from the contract manufacturer. (https://inoporex.de/en/wissen/legalhersteller/)
- **Contract manufacturer vs. filler** — Contract manufacturer vs. contract filler: who does what in the value chain? Definitions, regulatory responsibility and why INOPREX works with a network of both as the manufacturer. (https://inoporex.de/en/wissen/lohnhersteller-vs-lohnabfueller/)
- **Private label vs. white label** — Private label vs. white label: who owns the formulation, how exclusive is the product, what is the MOQ? The key differences with a comparison table. (https://inoporex.de/en/wissen/private-label-vs-white-label/)
- **ISO 13485:2016** — ISO 13485:2016 is the standard for quality management systems in medical devices: structure, requirements, certification and what a manufacturer owes from it. (https://inoporex.de/en/wissen/iso-13485/)
- **EU MDR classification** — Classification under EU MDR: 22 rules in Annex VIII assign medical devices to classes I, Is, Im, Ir, IIa, IIb and III. Principles, examples and consequences. (https://inoporex.de/en/wissen/eu-mdr-klassifizierung/)
- **MDR Article 16** — MDR Article 16 governs when a company sterilises, packages, relabels or repackages a finished medical device for sterility maintenance: it becomes a manufacturer itself — with all obligations. (https://inoporex.de/en/wissen/mdr-artikel-16/)
- **Technical documentation** — Technical documentation is the evidence that a medical device meets the general safety and performance requirements: structure under Annexes II and III of the EU MDR, PMS and update obligations. (https://inoporex.de/en/wissen/technische-dokumentation/)
- **PIF and CPNP** — The PIF (Product Information File) and CPNP notification are the core obligations for cosmetic products under Regulation (EC) No 1223/2009: file contents, responsible person, notification process. (https://inoporex.de/en/wissen/pif-cpnp/)
- **UDI and EUDAMED** — UDI (unique device identification) and EUDAMED: how medical devices are labelled and registered in the European database under EU MDR — UDI-DI, basic UDI-DI, modules. (https://inoporex.de/en/wissen/udi-eudamed/)
- **PRRC** — The PRRC under Article 15 of the EU MDR ensures regulatory compliance in the company: qualification profile, tasks, manufacturer obligation, possible role arrangements. (https://inoporex.de/en/wissen/prrc/)
- **Cosmetic claims** — Cosmetic claims under Regulation (EC) No 1223/2009 and Regulation (EU) No 655/2013: common criteria, evidential support and common sources of error. (https://inoporex.de/en/wissen/kosmetik-claims/)
- **Health claims and EFSA** — Health claims under Regulation (EC) No 1924/2006: only authorised, EFSA-assessed statements are permitted for food supplements. How to review, combine and document claims. (https://inoporex.de/en/wissen/health-claims-efsa/)
- **MOQ and calculation** — Why minimum order quantities exist, how contract manufacturers calculate them and how brand owners can plan MOQ, price and batch size strategically. (https://inoporex.de/en/wissen/moq-kalkulation/)
- **Notified bodies** — Notified bodies examine and certify medical devices of higher classes in the EU MDR conformity assessment: selection, procedures, MDR certificates and audit process. (https://inoporex.de/en/wissen/benannte-stellen/)
- **Borderline products** — Borderline products: borderline cases between medical devices, cosmetics and food supplements. Classification by intended purpose, mode of action and claims — with typical examples. (https://inoporex.de/en/wissen/borderline-produkte/)
- **Nitrile gloves: medical device and PPE** — Nitrile gloves can be both a medical device (examination glove under EU MDR) and personal protective equipment (PPE under Regulation (EU) 2016/425): classification, standards and labelling. (https://inoporex.de/en/wissen/nitrilhandschuhe-medizinprodukt-psa/)
- **Latex-free materials** — Latex-free materials in medical devices: polyisoprene, polyurethane and nitrile as alternatives to natural rubber latex — properties, type I allergy risk and labelling obligations. (https://inoporex.de/en/wissen/latexfreie-materialien/)