Description:
This Audit Checklist (MDR) helps us verify EU MDR transition readiness by checking key legal requirements across all MDR requirements including legacy devices, technical documentation, vigilance, PMS, and UDI, etc.

• Confirm certificate validity and transition status under Article 120(1)–(4).

• Check conditions for legacy devices under Article 120(3a)–(3e), including no significant changes.

• Verify continued availability rules for old devices under Article 120(10).

• Assess EUDAMED transition obligations under Article 123(d)–(ec) (modules and timelines).

• Confirm technical documentation coverage per Annex II/III and GSPR mapping to Annex I.

• Check UDI obligations and device registration expectations under Article 27 and Article 29.

• Verify vigilance reporting timelines under Article 87 and FSCA/FSN expectations under Article 89.

• etc.

Your needs:

• MDR audit checklist

• MDR audit checklist for MDR compliance

• Reduce audit rework, prevent transition gaps, and strengthen inspection readiness.

Use this checklist when auditing MDR transition, especially for legacy and “old” devices, to confirm certificate status, EUDAMED readiness, and lifecycle compliance decisions.

It focuses on evidence-based decisions. Legacy devices remain on the market under specific MDR transition conditions; this matters because “no significant change” must be defensible. EUDAMED modules affect when registration and reporting obligations switch; this matters because timing drives compliance actions.

• Confirm certificate validity and transition dates under Article 120.

• Verify legacy conditions, including no significant changes and QMS readiness.

• Check EUDAMED module applicability and interim processes under Article 123.

• Confirm UDI assignment, placement, and registration expectations.

• Verify PSUR and trend reporting expectations under Articles 86 and 88.

• Confirm vigilance 2/10/15-day timelines and documentation under Article 87.

• Verify FSCA/FSN communication and identification requirements under Article 89.

At Lexqara, we support audit execution, regulatory strategy, and QMS implementation with checklists, training, and CAPA linkage. Resource Center [https://lexqara.com/resource-center] and Audit & Inspection Support [https://lexqara.com/services/audit-and-inspection-support]. EU MDR (Regulation (EU) 2017/745) [https://eur-lex.europa.eu/eli/reg/2017/745/oj]. Request a short gap assessment.