Key reference documents, official texts and EUDAMED-related articles from EU MDR 2017/745 and IVDR 2017/746.
EU MDR
Medical Device Regulation — governs medical devices placed on the EU market. Fully applicable from May 2022 with ongoing transition provisions for legacy devices.
Art. 26
Art. 27
Art. 28
Art. 29
Art. 30
Art. 83
Art. 87
EU IVDR
In Vitro Diagnostic Regulation — governs IVD devices placed on the EU market. Fully applicable from May 2025 following extended transition periods.
Art. 24
Art. 25
Art. 78
Art. 82
Our scheduled training dates are available here.
EUDAMED is structured into six interconnected modules, each handling a different aspect of medical device regulation.
Registration of manufacturers, importers, authorised representatives, system/procedure pack producers and notified bodies. Generates the SRN.
Registration of devices by UDI-DI. Links devices to actors, certificates and clinical investigations.
Management of notified body designations and device certificates issued under MDR/IVDR.
Registration and reporting for clinical investigations (MDR) and performance studies (IVDR).
Electronic submission of Manufacturer Incident Reports (MIR) and Field Safety Corrective Actions (FSCA). Replaces the legacy PDF MIR form.
National competent authorities access for post-market surveillance activities.
Our team provides expert consultancy and EUDAMED registration services.
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