Module 19 2021

01/06/2021

Where is EUDAMED today?

• The new EUDAMED database is in development

• A common nomenclature system will be used, which will be free to users, which system is still to be decided

• Testing is now behind schedule

• Will be a phased launch, phase 1 unlikely to have machine to machine communication interface ready

• Paper system is fall back

01/06/2021 IVDeology Ltd | www.ivdeology.co.uk

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The big regulated markets - USA

The world biggest IVD market Regulator is the FDA IVDs are regulated as medical devices ● Three risk classifications I,II and III Regulated under CFR Part 820 but also consider 801, 803, 806, 807, 809, 812, 821,822, 830. Risk Management approach Registration is not required for Class I devices that are exempted Class II devices require a 510(k) submission and a file review. Measure substantial equivalence (SE/NSE)

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