Essentials of European Medical Device Regulatory Affairs - October 2019
Applications for CIs
Non CE marked devices (article 70) and CE marked devices outside of scope of intended purpose (article 74)
Process of CI Review- no cooperation between MS
Sponsor responds to Qs
respond to validation Qs 10days or MS may extend by amax20 days Article 70 (3)
Assessment 5days+5days Assessment 5days+5days Assessment 5days+5days
Approval Within45 daysof validation +20days if expert review required (Minus the sponsor response time.)
Validation 10days+5days Validation 10days+5days Validation 10days+5days
Confirm valid 5days+5days Confirm valid 5days+5days Confirm valid 5days+5days
MS 1 MS 2 MS n
Sponsor files Docume nts Article70
Electronic system PerArticle73
• Trial in scope • Documentscomplete • Article70(1)
Study number
Or reject
Sponsor can appeal
A CI can start for • Class I, non invasive IIA and non invasive IIB devices After validation and with no negative ethic opinion. • Other devices (invasive IIA , invasive IIB and class III) Notification of approval and with no negative ethic opinion. Article 70 (7)
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