AZ RegCheck

MDR Gap Check — documentation gap analysis

Technical documentation review against MDR 2017/745. You receive a gap report with remediation priorities — preparation for a notified body conversation, not a certification audit.

€1,800fixed-price · defined scope

5–10 daysafter documentation received

Ask about Gap Check WhatsApp

Who it is for

SMEs before a notified body discussion
Teams after major documentation changes
Internal QA/RA review before a formal audit

Who it is not for

“CE certification included”
Replacing a notified body audit
Guaranteed positive NB outcome

Scope

Review of provided technical documentation vs selected MDR requirements
Gap and inconsistency identification
Remediation priorities (high / medium / low)
Written report for internal use or pre-NB preparation

FAQ

Does this replace a notified body audit?

No. Gap Check is an advisory gap analysis. We are not a notified body and do not certify devices.

What documents should we send?

After kick-off we share a checklist. Typically: technical file TOC and selected sections. Do not send UDI or full DoC via WhatsApp — use email.

Want clarity on gaps before NB?

Describe device class and documentation status — we reply within 3 business days.

Ask about Gap Check How to read a gap report

AZ Regulatory is not a notified body. MDR Gap Check is not certification, a formal audit, or a guarantee of notified body outcome.