Essentials of European Medical Device Regulatory Affairs - June 2020

Process of CI Review-

no cooperation between MS

Sponsor respon ds toQs

respond to validationQs 10 days or MSmay extend by amax20 days Article 70 (3)

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

Confirm valid 5days +5days Confirm valid 5days +5days Confirm valid 5days +5days

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

Approv al Within45 days of validation +20days if expert review required (Minus the sponsor response time.)

MS 1 MS 2 MS n

Sponso r files Docum

Electronic system PerArticle73

Validation 10days +5days

ents Article70

• Trial in scope • Documents complete • Article 70(1)

Study numb er

Or reject

Sponsor can appeal

ACI can start for • Class I, non invasive IIAand 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)

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

respond to validationQs 10 days or MSmay extend by amax20 days Article 70 (3)

Approval Or approvalwith conditions Within45daysofvalidation And5days ofFinalAR +50days ifexpertreview requiredforclass IIband III

Validation 7days Validation 7days Validation 7days

MS 1 MS 2 MS n

MS c Valida tion Withi n 10 days of submit

Sponso r files docum

Electronic system PerArticle73

Confirm valid 5days + 5 days

Draft AR 26 days post valid

Final AR 45 days post valid

MS n comme nts by day 38

ents Article70

(Minus thesponsor response time.)

Study numb er

Coordinating MS assigned within6days

MS n can disagree With an approval of MS c BasedonArticle78 (8) Rejection byMS c is

Propose a coordinatingMS. fordevicesthat require assessment Article78

Sponsor respon ds toQs from MS n or MS c <12days

Or reject

• Trial in scope • Documents complete • Article 70(1)

ACI canstart for • Class I, non invasive IIA andnoninvasive IIB devices Aftervalidationandwithnonegative ethicopinion. • Otherdevices (invasive IIA , invasive IIB and class III) Notificationof approval andwithnonegative ethic opinion. Article70 (7)

applicable to allMS n

Sponsor can appeal

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

Sponsor files Documents (Tracked) with explanation Within 7days

MS 1 MS 2 MS n

Electronic system PerArticle73

• MS indicates a refusal • Or • Ethics negative opinion

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

will comment on the documents in their scope ,

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