Description:
This MDR GSPR checklist documents conformity to Annex I of Regulation (EU) 2017/745 and supports Annex II.4 technical documentation expectations.

• Define [Device Name], manufacturer, document number, Revision, and controlled Approvals.

• State the checklist Objective and intended purpose context for the device.

• Build an evidence of conformity table with document ID, revision, and exact technical file location.

• Assign item numbers [X] to ensure end-to-end traceability between evidence and GSPRs.

• Evaluate each GSPR as A/NA and record a justification when non-applicable.

• Document Solutions Applied (harmonized standards, common specifications, state of the art, MDCG).

• Conclude overall conformity to Annex I based on compiled evidence.

Your needs:

• MDR GSPR checklist

• MDR GSPR checklist for MDR decision-making

• Reduce rework, speed up reviews, and strengthen audit readiness.

Use this checklist when compiling or updating EU MDR technical documentation to show structured, reviewable evidence against Annex I requirements.

It ensures consistency across teams. A/NA means each GSPR is assessed for applicability; it matters because “NA” must be justified. Traceability links each GSPR to controlled evidence; it matters because reviewers must find proof quickly.

• Maintain controlled identifiers, approvals, and revision history.

• Compile evidence with document number, revision, and file location.

• Assign item numbers to connect evidence and GSPR entries.

• Document solutions applied and methods used for conformity.

• Record NA justifications and keep them device-specific.

• Provide a clear conclusion on Annex I conformity.

At Lexqara, we streamline GSPR traceability, evidence mapping, and technical documentation alignment so your files are consistent and inspection-ready. Resource Center [https://lexqara.com/resource-center] and Regulatory Strategy [https://lexqara.com/services/regulatory-strategy]. EU MDR (Regulation (EU) 2017/745) [https://eur-lex.europa.eu/eli/reg/2017/745/oj]. Download the template and request a short gap assessment.