Module 15 2022

5/19/2022

MEDDEV 2.7.1 Rev 4 Scope of the Maintenance CER

CER Sections

Submission

Maintenance

Device Description

X X

X X

Specifications, Indications, contra-indications, populations, claims

SOTA

X X X

X+

Equivalence assessment

Data from Equivalent devices, if any (publications and PMS)

(X)

Pre-clinical Data

X X

X X

Consistency with Device Materials (IFU, Brochures…) Potential changes and their clinical impact New clinical concerns from experience PMS/PMCF on the actual device (incl. PSUR, SSCP)

X X X

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© NAMSA 2021

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PMS/PMCF Plans

Pre clinical

Once per device

Clinical Investigation

CER Submission

CE mark

CER

Vigilance

Annual Update!

PMS

SSCP

PMCF

Complaint

PSUR

Surveillance/li tterature

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© NAMSA 2021

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