Regulation on the European Health Data Space (EHDS)
EHR systems: requirements and economic operators – Regulation on the European Health Data Space (EHDS)

Regulation on the European Health Data Space (EHDS) 37: Draw up Annex III technical documentation and produce it within 30 days of a request

Article 37 with Annex III: before placing on the market or putting into service, manufacturers draw up and keep updated technical documentation demonstrating Annex II compliance, containing at least the Annex III elements (intended purpose, version, data categories, interactions, software versions, forms of supply, hardware, architecture, specifications and data structures, lifecycle changes, instructions, performance evaluation, common specifications applied, verification and validation results, the information sheet and declaration) and the result from the European digital testing environment, in an understandable language; it is supplied, with translations, within 30 days of a request, failing which an independent test may be imposed at the manufacturer's cost.

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

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