Module 18 2021

07/02/2021

Meanwhile… which guidances are relevant for DDCs and where do they come from? ● EU: shortage of guidances e.g. DRAFT Quality requirements for DDCs

● FDA: Multiple Guidances for Combination Products https://www.fda.gov/combination-products/guidance- regulatory-information/combination-products-guidance- documents :

The Organisation for Professionals in Regulatory Affairs

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Global Transferability

Different Systems for Classification/Application of Devices

Japan • Pre-Market Submission (Notification) • Pre-Market Certification • Pre-Market Approval

USA

• Pre-Market Notification 510K • PMA (Pre-Market Approval)

EU

• Class I Self-Certification • Notified Body Certification

The Organisation for Professionals in Regulatory Affairs

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