Essentials of European Medical Device Regulatory Affairs

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)