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AI EU MDR GSPR Evidence Gap Review

Paste your device description and technical-document evidence. The agent inventories what you supplied, reviews it against EU MDR Annex I areas, and returns evidence references, gaps, missing documents, and prioritized next actions.

Free · no loginStructured outputPaste up to 50,000 charactersCurrent-source checks when useful

Paste your device and technical-document evidence

Try an example

Paste an IFU, device description, risk-management summary, verification and validation index, standards list, clinical evidence summary, or several excerpts together. Add document names and section or page references when available.

Separate documents with headings when possible. Do not paste patient-identifying information.0 / 50,000
Privacy: Pure Global does not publish this pasted text or generated workpaper. It is processed for this review and sent to our AI provider. Avoid patient-identifying information and confidential material you are not authorized to share.
About this agent

What to paste for a useful review

Start with the intended purpose and key device characteristics, then add excerpts or indices from the risk management file, verification and validation, biological evaluation, software and cybersecurity evidence, usability, clinical evaluation, labeling, sterilization, packaging, and post-market planning.

Include document names and section or page references when available.

Review consolidated EU MDR ↗

What is a GSPR checklist?
A GSPR checklist maps the General Safety and Performance Requirements in EU MDR Annex I to applicability decisions, evidence, standards, test reports, risk controls, labeling, and other technical documentation. This tool performs a preliminary AI review of the evidence text you paste.
Does every EU MDR Annex I requirement apply to every device?
No. Applicability depends on the device design, intended purpose, users, environment, and features. Each exclusion should be justified rather than assumed.
Is this checklist enough for CE marking?
No. It is a preliminary gap-assessment aid, not a conformity assessment or a complete technical documentation template. Manufacturers must use the current legal text and applicable standards and guidance.

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More European Union medical device resources

View the European Union resource hub →