Essentials of European Medical Device Regulatory Affairs

Process of Clinical Investigation Review- cooperation (voluntary process for MS until 2027)

respond to  validation Qs 10days  or  MS may  extend by amax20  days Article 70 (3) 

Approval Or approval with  conditions Within45daysof validation And5daysof FinalAR  +50days if expert review  required for class IIband III (Minus the sponsor response  time.)

Validation 7days Validation 7days Validation 7days

MS 1 MS 2 MS n

MS c Validat ion Within 10daysof  submit

Sponsor  files docume nts Article70 Proposea  coordinatingMS. fordevices that  require assessment Article78

Electronic system PerArticle73

Confirm  valid 5days + 5  days

Draft  AR 26days

Final  AR 45days

MS n comment s by day 38

post  valid

post  valid

Study  number

Coordinating  MS assigned within 6 days

MS n can  disagree With an 

Sponsor  responds 

Or reject

• Trial in scope • Documentscomplete • Article70(1)

approval of MS c BasedonArticle 78 (8)

to Qs  from  MS n MS c <12days

or 

Rejectionby  MS c is  applicable  toall MS n

Sponsor  can appeal

A CI can start for • Class I, non invasive IIA and noninvasive 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)

Changes to documents/ trial

If documents submitted change, provide to electronic system within 7 days (tracked). Article 70 (2)

Substantial modifications (Article 75)

Implement modification 38 days from notification unless • MS requires +7 days to consult experts • MS indicates a refusal • Or • Ethics negative opinion

Sponsor files Documents (Tracked) with  explanation Within 7 days

MS 1 MS 2 MS n

Electronic system PerArticle73

If a coordinated assessment: MS n but can only reject as per article 78(8)

will comment on the documents in their scope ,