Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

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

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The big regulated markets - USA

 Class III devices are highest risk (Pre-Market Approval) and need full audit as well as file review.  Consensus standards are set such as ISO14971 and include CLSI for device performance criteria  Clinical Study in US  Instruments must meet 60601-1 (EU EMC/Safety OK) but are considered as Class I  Mftr must have a FURLS registration of site and products  UDI Requirements for Class II and III products

 US agent required  Costs $5k-$250K  time 90 days to 2 years

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