Knowledge
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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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PRRC
The PRRC under Article 15 of the EU MDR ensures regulatory compliance in the company: qualification profile, tasks, manufacturer obligation, possible role arrangements.
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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.
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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.
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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.
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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.
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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.
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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.
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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.