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Reviewed guidance topic

In-house devices

Health-institution exemption and in-house device manufacture/use.

Official catalogue · non-binding

In-house devices guidance (1)

Catalogue entries are ordered as they appear in the European Commission catalogue.

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MDCG 2023-1Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746January 2023