MDR gap analysis: how to read a gap report before NB

How to set remediation priorities before a notified body conversation — and what a gap check is not.

Informational material, not legal advice. Gap check ≠ notified body audit or certification.

I most often see 40+ gap lists with no owner and no date. The report sits in SharePoint while the file that goes to NB still has a hole in GSPR or risk management.

Gap check vs NB audit

A gap report is an internal tool: it shows where documentation diverges from MDR and what to close first. It does not replace a formal NB audit and does not “issue CE”.

How to read priorities

High: missing or conflicting critical areas (e.g. GSPR, risk, clinical/eval, IFU) — close before formal NB engagement
Medium: inconsistencies NB will likely probe — dated remediation plan
Low: editorial / TOC polish — do not block the critical path

What to do with the report

Assign an owner to each gap (QA / RA / R&D)
Separate corrections needed before the first notified body discussion from those that can be scheduled later.
Do not mix remediation with “hope NB will not notice”

Fixed-price service: MDR Gap Check.

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