Essentials of European Medical Device Regulatory Affairs

Process of CI Review No co-operation between MS

respond to validationQs 10days or MS may extend byamax 20 days Article70 (3)

Sponsor responds to Qs

Assessment 5days + 5days Assessment 5days + 5days Assessment 5days + 5days

Approval Within45 daysof validation

Validation 10days+5days Validation 10days+5days

Confirmvalid 5days + 5days Confirmvalid 5days + 5days Confirmvalid 5days + 5days

MS 1 MS 2 MS n

Sponsor files Docume nts Article 70

Electronic system PerArticle73

+20days if expert review required (Minus the sponsor response time.)

Validation 10days+5days

• Trial in scope • Documents complete • 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)

The Organisationfor Professionals inRegulatory Affairs

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

respond to validationQs 10days or MS may extend byamax 20 days Article70 (3)

Approval Orapproval with conditions Within45daysofvalidation And5daysofFinalAR

Validation 7days Validation 7days Validation 7days

MS 1 MS 2 MS n

MS c Validat ion Within 10daysof submit

Sponsor files docume nts Article 70 Propose a coordinating MS. fordevices that require assessment Article 78

Electronic system PerArticle73

Confirm valid 5days+5 days

Draft AR 26days

Final AR 45days

MS n comment s byday38

+50days ifexpert review required for class IIband III

post valid

post valid

(Minus the sponsor response time.)

Study number

Coordinating MS assigned within 6 days

MS n can disagree Withan

Sponsor responds to Qs from MS n or MS c <12days

Or reject

• Trial in scope • Documents complete • Article70(1)

approvalof MS c BasedonArticle78 (8)

Rejectionby MS c is applicable toallMS n

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)

Sponsor can appeal

The Organisationfor Professionals inRegulatory Affairs