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MDR Knowledge Hub

Your dose of knowledge

The Knowledge Base is a dedicated resource where you can find reliable information on the certification and conformity assessment of non-active medical devices, prepared by the experts of our Notified Body. We publish practical guidance, interpretations of the Medical Device Regulation (MDR) requirements, and analyses of relevant standards to help you better understand the applicable regulations and their practical implementation.

Our content is based on the latest approach to conformity assessment and the extensive experience gained through certification processes. As a result, you gain access to a trusted source of knowledge that supports manufacturers at every stage of bringing medical devices to the market.

Equivalence as a Basis for Using Clinical Data in MDR Conformity Assessment

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Usability Engineering of Non-Active Medical Devices in Light of the MDR — Practical Aspects of Preparing Technical Documentation

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The Impact of a Medicinal Substance on the Assessment of Medical Device Documentation

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Borderline Substance-Based Medical Devices – how not to get lost in the regulatory jungle of qualification during the design stage?

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Non-active medical devices – what they are and what requirements they must meet according to the MDR?

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