Essentials of European Medical Device Regulatory Affairs

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 7 days

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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CE marked devices – used per label but additional procedures (Article 74)

E.g. Post market clinical follow up (PMCF) studies

In the case of implantable devices and class III devices, where clinical investigations have not been performed, the notified body shall check that the PMCF plan is appropriate and includes post market studies to demonstrate the safety and performance of the device. Article 61(4) Sponsor notifies MSs via at least 30 days prior to study start. Electronic system PerArticle73

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