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)