GSPR · Annex I
GSPR compliance with evidence you can trace
GSPR compliance means showing, for every General Safety and Performance Requirement in MDR Annex I, whether it applies to the device, how it is met and which evidence proves it. The GSPR checklist is part of the technical documentation (Annex II, Section 4) and is usually the first place a notified body reviewer looks. In MDRpilot each requirement is a row with applicability, justification for non-applicable items, the method and harmonised or other standards used, and the linked evidence documents.
Who it is for
- Regulatory teams building a GSPR checklist for the first time
- Manufacturers converting MDD Essential Requirements to MDR GSPR
- Teams preparing for a technical documentation review
Key capabilities
Full Annex I checklist
All GSPR sections with applicability and justification.
Standards per row
Applied standards are recorded per requirement and per product.
Suggested evidence links
Uploaded reports are matched to rows by standard; you confirm each link.
Bulk status updates
Set status for groups of rows when a decision applies to all of them.
XLSX export
Export the checklist for review or submission.
How Annex I is organised
| Chapter | Scope |
|---|---|
| Chapter I (Sections 1–9) | General requirements: safety and performance, risk management, risk reduction, benefit-risk, and residual risk |
| Chapter II (Sections 10–22) | Design and manufacture: chemical, physical and biological properties, infection and contamination, devices with a measuring function, radiation, software and electronic systems, active devices, mechanical risks, devices for lay persons |
| Chapter III (Section 23) | Information supplied with the device: label and instructions for use |
What a defensible GSPR row contains
- Applicability: yes, no, or applicable with justification
- For non-applicable rows, a reason that follows from the device description
- The method used to demonstrate conformity, such as a standard, test or analysis
- The standard and edition, if one is applied
- A reference to the controlled document that holds the evidence
How evidence reaches the matrix
When you upload a test report, MDRpilot reads it for the standard it follows and its verdict. Reports that pass and match a standard listed on a GSPR row are proposed as evidence for that row with a confidence score. You confirm or reject each proposal. A report that fails is never linked as evidence; it adds a gap note to the row instead.
How the workflow runs
- 1
Load the checklist
Start from the Annex I structure for the product.
- 2
Decide applicability
Use the device description to justify non-applicable rows.
- 3
Assign methods and standards
Record how each requirement is met.
- 4
Attach evidence
Upload reports and confirm the suggested links.
- 5
Review gaps
Rows without evidence appear in the readiness view.
Connected to the rest of the file
MDRpilot is not a stand-alone document generator. Requirements, evidence and documents share one product record.
Each step reads from the same product record. A test report linked to a GSPR row can verify a risk control, a change to the device class flags the documents that depend on it, and the audit readiness view counts what is still open across all of them.
Limitations
- MDRpilot does not decide whether a standard is sufficient for a requirement; it records your choice.
- Automated reading of test reports can misread poorly scanned documents; every link requires confirmation.
- Harmonised standard status changes over time; check the current list published in the Official Journal.
MDRpilot is documentation and workflow software. It is not a medical device, not a notified body and not a regulatory authority. It does not certify devices or guarantee compliance; AI-generated drafts must be reviewed and approved by qualified people in the manufacturer's organisation.
Frequently asked questions
What does GSPR stand for?
General Safety and Performance Requirements, set out in Annex I of Regulation (EU) 2017/745. They replaced the Essential Requirements of the Medical Devices Directive.
Can MDRpilot manage GSPR evidence?
Yes. Each GSPR row can hold linked evidence files, and uploaded test reports are proposed as evidence when their standard and verdict match. You confirm every link.
Do I need a justification for non-applicable GSPRs?
Yes. The technical documentation should explain why a requirement does not apply. MDRpilot provides a field for this justification on every row.
Is using a harmonised standard mandatory?
No. Harmonised standards give a presumption of conformity for the requirements they cover, but other methods can be used if you justify them.
Can I export the GSPR checklist?
Yes, as an XLSX file, and it is included in the technical file export.
Related workflows
- MDR technical documentation under Annex II and Annex IIIWhat MDR Annex II and Annex III require in the technical documentation, section by section, and how each section is handled in MDRpilot.Read more
- ISO 14971 risk management software connected to your evidenceMaintain an ISO 14971:2019 risk management file per device: plan, hazard analysis, risk controls, verification of controls and benefit-risk, linked to GSPR and PMS.Read more
- Technical file software for MDR devicesBuild and maintain an MDR technical file per device: Annex II and III structure, section status, AI-assisted drafts, linked evidence and DOCX, PDF or ZIP export.Read more
- MDR gap analysis that turns findings into actionsFind what is missing between your current documentation and EU MDR: GSPR evidence, clinical data, PMS, QMS procedures and change-related gaps, with clear next actions.Read more
- Audit readiness for MDR and ISO 13485 auditsPrepare for notified body and internal audits with a readiness score, a list of missing actions across technical file, QMS and CAPA, and an audit simulator.Read more
Guides and resources
- What Is GSPR Compliance?What the General Safety and Performance Requirements are, how Annex I is organised, how to document GSPR compliance and the mistakes reviewers find most often.Read more
- MDR Annex II and Annex III ExplainedSection-by-section explanation of MDR Annex II (technical documentation) and Annex III (technical documentation on post-market surveillance), with what reviewers look for.Read more
- How to Build an MDR Technical FileA practical sequence for building an MDR technical file: intended purpose, classification, GSPR, risk, verification, clinical evaluation, labelling, PMS and final review.Read more
References
- Regulation (EU) 2017/745 on medical devices (MDR) — EUR-Lex, Publications Office of the European Union.
- Guidance: MDCG endorsed documents and other guidance — European Commission.
Always check the consolidated text of the regulation and the current version of each guidance document before relying on it.
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