Brochure
Medical Devices

IVDR Conformity Assessment Routes

Notified Body Assessments.

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In this document:

Classification rules under the IVDR.
Assessment Routes for your IVD.
CE Excellence - Standard and Dedicated.
How BSI supports your Medical Devices launch.

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EU MDR – Post Market Clinical Follow-Up

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Annex XVI - Devices Without an Intended Medical Purpose

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Using Standards to Demonstrate Conformity

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Unlocking the Potential of Consumer Wearables in Healthcare

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Medical Device Lifetime - Assisting manufacturers

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Symbols & Details Required for Medical Devices & IVDs

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