The comprehensive guide to EUDAMED — covering Actor Registration, and UDI/Device Registration. Written by EirMed's regulatory experts for manufacturers, importers and PRRCs.
EudaMedSimplified
The Manual
EirMed Ltd · eudamed.com
EudaMed Simplified is the definitive plain-English guide to EUDAMED — covering all actor types, all device categories, and the full submission workflow for both MDR and IVDR, in addition to legacy devices.
Written by EirMed's regulatory team — the same experts who run eudamed.com and handle thousands of EUDAMED submissions. This is practical, hands-on knowledge, not a re-statement of the regulation.
EudaMed Simplified — The Manual
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Structured around the Actor and UDI Devices EUDAMED modules — each explained from first principles.
The purpose of EUDAMED, its legal basis under MDR and IVDR, the six modules, and the timeline to mandatory use in May 2026.
Step-by-step guide to registering your organisation and obtaining an SRN — for manufacturers, importers, authorised representatives and system/procedure pack producers.
How UDIs work, the difference between Basic UDI-DI and UDI-DI, and how to register devices correctly in EUDAMED — with worked examples.
Planning or executing EUDAMED registration for your device portfolio under MDR or IVDR.
Understanding your MDR Article 13 obligations and how EUDAMED affects your supply chain.
The Vigilance chapter is essential reading for Persons Responsible for Regulatory Compliance.
A complete reference for regulatory affairs professionals navigating EUDAMED day-to-day.
The definitive plain-English guide to EUDAMED — instant PDF download.
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