Description:
This IVDR GSPR checklist documents compliance to Annex I of Regulation (EU) 2017/746 and supports technical documentation expectations in Annex II.4.

• Define controlled identifiers: [Device Name], Manufacturer name, Document Number, Revision, Approval, and Revision History.

• State the checklist Objective and include the device intended purpose statement.

• Build an evidence of conformity table with Document Number, Revision, and exact location in the Technical Documentation.

• Assign a unique item number [X] to ensure traceability between evidence and each GSPR line.

• Evaluate each GSPR as A/NA and document a justification for non-applicable items.

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

• Provide a clear Conclusion on compliance to IVDR Annex I.

Your needs:

• IVDR GSPR checklist

• IVDR GSPR checklist for IVDR decision-making

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

Use this checklist when compiling or updating IVDR technical documentation to prove structured, reviewable evidence against Annex I requirements.

It standardizes decisions. A/NA confirms applicability; it matters because “NA” must be device-specific and justified. Traceability item [X] links each GSPR entry to controlled evidence; it matters because reviewers must find proof quickly.

• Maintain identifiers, approvals, and revision control.

• Map evidence to GSPRs with item numbering and document locations.

• Record solutions applied and methods used for conformity.

• Keep document numbers and revisions aligned to controlled records.

• Justify non-applicable GSPRs consistently.

• Conclude compliance to Annex I based on compiled evidence.

At Lexqara, we streamline GSPR evidence mapping, traceability tables, and technical documentation alignment for IVDR submissions. Resource Center [https://lexqara.com/resource-center] and Regulatory Strategy [https://lexqara.com/services/regulatory-strategy]. IVDR (Regulation (EU) 2017/746) [https://eur-lex.europa.eu/eli/reg/2017/746/oj]. Download the template or request a short gap assessment.