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.
Prices in EUR, excluding VAT. VAT treatment will be specified in the individual proposal.
Opens your email app. The initial consultation is free.
When this service helps
- SMEs before a notified body discussion
- Teams after major documentation changes
- Internal QA/RA review before a formal audit
Inputs and scope boundaries
- CE certification falls outside the scope of this service.
- The review does not replace a notified body audit.
- The outcome of the notified body assessment is not guaranteed.
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 the initial consultation we share a checklist. Typically: technical file TOC and selected sections. Do not send UDI or full DoC via WhatsApp. Documentation is shared through the agreed channel.
Want clarity on gaps before NB?
Describe device class and documentation status — we reply within 3 business days.
Discuss this service by email How to read a gap reportAZ Regulatory is not a notified body. MDR Gap Check is not certification, a formal audit, or a guarantee of notified body outcome.