EU MDR GSPR Checklist: Annex I Evidence
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Map each applicable General Safety and Performance Requirement to controlled evidence and a documented compliance conclusion.
What is the EU MDR GSPR checklist?
The General Safety and Performance Requirements (GSPRs) in MDR Annex I define the safety and performance outcomes a device must meet. Technical documentation under Annex II must explain how the manufacturer demonstrates conformity. A GSPR checklist is the traceable evidence map for that explanation; it is not a certificate or a substitute for test reports.
Start with the device’s intended purpose, configuration, patient population, users and use environment. Confirm whether the product falls under MDR or IVDR; their Annex I requirements differ. A medical-device checklist cannot simply be relabeled for an IVD.
Checklist fields that make review possible
| Field | What to record | Common weakness |
|---|---|---|
| Requirement reference | Exact Annex I section and subparagraph | One row for a broad chapter hides applicable details |
| Applicability | Yes/no with a device-specific rationale | “Not applicable” without an explanation |
| Method of conformity | Standard, common specification or another justified method | Assuming a test standard covers every aspect of the requirement |
| Evidence | Controlled report identifier, revision and relevant section | A generic reference to the entire technical file |
| Conclusion and gaps | Supported result, remaining gap and owner | Marking compliant before final evidence exists |
| Change control | Review date, affected configuration and update trigger | Checklist no longer matches the marketed version |
Keep the legal requirement, method and evidence separate. A standard is a method supporting a conclusion; the report shows what was actually done. Determine whether a harmonized standard’s published reference and scope support the claimed presumption of conformity, and address gaps or other applicable requirements.
Practical evidence-map examples
The following examples illustrate the reasoning process rather than prescribing one universal test package:
| Requirement area | Device-specific question | Evidence to assess |
|---|---|---|
| Risk and benefit-risk | Have foreseeable hazards and residual risks been addressed for the claimed use? | Risk plan/file, benefit-risk conclusions and clinical evidence |
| Chemical/biological properties | What contact materials, durations and populations are relevant? | Material characterization and justified biological evaluation |
| Infection and contamination | Does the sterile/reprocessing claim match validated conditions? | Sterilization, packaging, cleaning or reprocessing validation as applicable |
| Electronic/software functions | Are safety, performance and security claims supported in the final configuration? | Software, electrical, cybersecurity and system verification/validation |
| Information supplied | Do labels and IFU communicate the approved purpose and residual risks? | Controlled labeling, translations and usability evidence where applicable |
Evaluate the actual subparagraphs, not just these headings. An IVD additionally requires the appropriate scientific-validity, analytical and clinical-performance evaluation under the IVDR framework.
From gap assessment to conformity conclusion
- Establish the product scope and applicable legislation.
- Assess every Annex I requirement and document nonapplicability.
- Identify methods, current standards and required evidence.
- Reconcile existing reports against device versions, claims and acceptance criteria.
- Assign missing evidence to owners and complete it before declaring conformity.
- Review the final matrix against the technical file, risk management, clinical evaluation and labels.
The Notified Body reviews applicable evidence within its conformity-assessment scope, but the manufacturer remains responsible for compliance and the Declaration of Conformity. A reviewer’s template is helpful only if it preserves the complete legal and technical mapping.
Maintain the checklist after CE marking
Reassess the matrix when design, materials, software, manufacturing, claims or labeling change, or when PMS, PSUR or clinical findings alter the evidence. A new standard edition calls for an applicability and state-of-the-art assessment rather than an automatic assertion that every existing report is obsolete.
Consult the Commission’s guidance index for current product and process guidance. Pure Global can support an Annex I gap assessment, evidence mapping and technical-documentation review with a clear distinction between completed conformity evidence and unresolved work.
For regulatory terminology and the authority framework, see the EU MDR.
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Frequently asked questions
No. It maps requirements to applicability rationales, methods and controlled evidence. Each compliance conclusion must be supported by the actual technical, clinical, quality or labeling records for the defined device.
The regulations have different Annex I requirements. A shared working method may help, but each checklist must map the correct regulation and device-specific requirements, including IVD performance evidence where applicable.
No. Assess every requirement and justify any nonapplicability for the actual intended purpose and configuration. An unexplained exclusion or a blanket chapter-level answer can hide an evidence gap.
No. A quality-management system supports compliance, but Annex I also requires product-specific safety and performance evidence. Standards, clinical/performance data, risk management and labeling must be mapped to the relevant requirements.
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