EU MDR GSPR Checklist Template: Annex I Evidence Matrix for Technical Documentation
Downloadable EU MDR GSPR checklist template for Annex I evidence mapping, applicability, standards, gap analysis, ownership, and remediation tracking.
Ran Chen
Global MedTech Expert | 10× MedTech Global Access
Published 2026-04-30Last reviewed 2026-04-3020 min read
Why You Need a Structured GSPR Checklist
Before any medical device can bear the CE mark under Regulation (EU) 2017/745, the manufacturer must demonstrate conformity with all 23 General Safety and Performance Requirements (GSPR) in Annex I. While the regulation does not explicitly mandate a "checklist" format, Notified Bodies universally expect to see a structured GSPR evidence matrix in every technical documentation submission. Greenlight Guru, Qualio, and OpenRegulatory all offer GSPR checklist templates — but most are gated behind registration or subscription walls.
This article provides a complete, free GSPR evidence matrix template with every requirement mapped to applicable harmonised standards, evidence types, and practical guidance. It is designed as a companion to our EU MDR GSPR Complete Walkthrough — use that article for the detailed explanation of each requirement, and this template to build your actual compliance artifact.
If you prefer to work through Annex I in a browser before transferring the results into your controlled technical file, Pure Global AI offers a free EU MDR GSPR checklist. Use it as a scoping and gap-tracking aid; the approved evidence matrix in your QMS should still point to the current MDR text, standards, and controlled records.
How to Use This Template
Matrix Structure
Each row in the evidence matrix corresponds to one GSPR sub-requirement. The columns are:
| Column | Purpose | How to Fill |
|---|---|---|
| GSPR No. | Requirement number from Annex I | Pre-populated |
| Requirement Summary | Brief description | Pre-populated; cross-reference full text in Annex I |
| Applicable? | Whether this requirement applies to your device | Yes / No / Partial |
| Applicability Rationale | Justification for applicability decision | Required for every row, including "No" |
| Method of Compliance | How conformity is demonstrated (testing, analysis, inspection, design) | State the approach |
| Harmonised Standard(s) | Standards used to demonstrate compliance | List specific standard and clause |
| Evidence Document(s) | Actual proof — test reports, analyses, design documents | File names or document IDs |
| Document Location | Where in the technical file the evidence is found | Section/page reference |
| Responsible Owner | Person or team accountable for this requirement | Name and role |
| Status | Current compliance state | Compliant / In Progress / Gap |
| Gap Description | If not compliant, what is missing | Describe the gap |
| Remediation Plan | How and when the gap will be closed | Action, deadline, owner |
| Last Review Date | When this row was last assessed | Date |
Rules for Applicability
A GSPR may be marked "No" only if the device categorically does not involve that domain. For example, a pure software device may mark GSPR 16 (measurement function) as "No" if it performs no measurements. However, the rationale column must contain a clear justification. Notified Bodies frequently challenge blanket "Not Applicable" entries without justification.
Chapter I: General Requirements (GSPR 1–4)
GSPR Evidence Matrix — Chapter I
| GSPR | Requirement Summary | Typical Applicability | Key Harmonised Standards |
|---|---|---|---|
| 1.1 | Devices achieve the performance intended by their manufacturer | All devices | ISO 13485, device-specific standards |
| 1.2(a) | Risk management throughout design, manufacture, use | All devices | ISO 14971:2019, ISO/TR 24971:2020 |
| 1.2(b) | Risks reduced as far as possible without adversely affecting benefit-risk ratio | All devices | ISO 14971:2019 |
| 1.3 | Replaceable by less invasive alternatives where possible | All devices (consider in design rationale) | N/A (design documentation) |
| 1.4 | Performance not affected by normal conditions of use and stresses | All devices | Device-specific performance standards |
| 1.5 | Device usable in intended environment, compatible with other equipment | All devices | IEC 60601-1-2 (EMC), IEC 62366-1 (usability) |
| 1.6 | Characteristics and performance not adversely affected during lifetime | All devices | Aging/shelf-life studies, stability data |
| 1.7 | Transport and storage not adversely affecting device | All devices | ASTM D4169, ISO 11607 |
| 1.8 | Benefits must outweigh side effects | All devices | ISO 14971 benefit-risk analysis |
| 1.9 | State of the art considered in risk management and clinical evaluation | All devices | Literature review, SOTA analysis |
| 1.10 | Cooperation between manufacturers of combined/integrated devices | Systems and combos | Interface agreements |
| 2.1 | Risk control: eliminate or reduce risks as far as feasible | All devices | ISO 14971 |
| 2.2 | Risk reduction: adequate protection measures including alarms | All devices | ISO 14971, IEC 60601-1 |
| 2.3 | Users informed of residual risks | All devices | IFU, labeling |
| 2.4 | As low as reasonably practicable (ALARP) residual risks | All devices | ISO 14971 risk acceptability matrix |
| 3.1 | Include or allow connection to devices for safe removal of substances | Applicable devices | Device-specific |
| 3.2 | Safe injection/puncture where applicable | Injection/puncture devices | ISO 7864, ISO 11608 |
| 3.3 | Minimize risks from leakage or substance ingress at connections | Applicable devices | IEC 60601-1 |
| 3.4 | Biological risks minimized for tissues, cells, body fluids | Contact devices | ISO 10993 series |
| 3.5 | Compatible with substances/devices they contact | Applicable devices | Compatibility testing |
| 3.6 | Invasive body orifice devices — specific requirements | Invasive devices | Design documentation |
| 3.7 | Surgically invasive devices — specific requirements | Surgical devices | Design documentation |
| 3.8 | Implantable devices — specific requirements | Implants | ISO 10993, ISO 14698 |
| 4.1 | Infection risk minimization | All devices | ISO 11737, ISO 17664, ISO 17665 |
| 4.2 | Tissue, cell, or substance of animal origin | Applicable devices | Regulation (EU) 722/2012 |
| 4.3 | Minimize particulate contamination | All devices | ISO 14644, particulate testing |
| 4.4 | Substances — CMR, endocrine disruptors | Devices containing such substances | REACH, CLP Regulation |
| 4.5 | Nanomaterials — minimize exposure | Devices with nanomaterials | ISO/TR 10993-22 |
| 4.6 | Intended to deliver medicinal product — compatibility | Drug-delivery devices | Compatibility studies |
| 4.7 | Medicinal product subject to additional requirements | Combination products | Consult NB, Directive 2001/83/EC |
| 4.8 | Blood derivative or human tissue | Applicable devices | Regulation (EU) 2017/745 Art. 1(6) |
| 4.9 | Incorporates medicinal product | Combination devices | EMA/NB consultation |
Template Row Example — GSPR 1.2(a)
| Column | Entry |
|---|---|
| GSPR No. | 1.2(a) |
| Requirement Summary | Risk management applied throughout design, manufacture, and use |
| Applicable? | Yes |
| Applicability Rationale | All medical devices require systematic risk management |
| Method of Compliance | ISO 14971:2019 risk management process applied from design inputs through post-market |
| Harmonised Standard(s) | ISO 14971:2019; ISO/TR 24971:2020 |
| Evidence Document(s) | RM-001 Risk Management File; RM-002 Risk Management Report v3.2 |
| Document Location | Technical File Section 6 (Risk Management) |
| Responsible Owner | J. Mueller, RA Manager |
| Status | Compliant |
| Gap Description | — |
| Remediation Plan | — |
| Last Review Date | 2026-04-15 |
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Chapter II: Requirements Regarding Design and Manufacture (GSPR 5–22)
GSPR Evidence Matrix — Chapter II Sections
Chemical, Physical, and Biological Properties (GSPR 5–7)
| GSPR | Requirement Summary | Typical Applicability | Key Harmonised Standards |
|---|---|---|---|
| 5.1 | Chemical, physical, biological properties suitable for intended use | All devices | ISO 10993-1, ISO 10993-18 |
| 5.2 | Physical properties (tissue compatibility, etc.) | Contact devices | ISO 10993 series |
| 5.3 | Compatible with physical and chemical properties of tissues | Tissue-contact devices | ISO 10993-1 |
| 6.1 | Minimize risks from substance contact (toxicity, flammability) | All devices | ISO 10993-1, ISO 14971 |
| 6.2 | Minimize risk of substances leaking into/onto body | Fluid-path devices | Extraction studies |
| 6.3 | Minimize risks from contaminants and residues | All devices | ISO 10993-7, ISO 10993-18 |
| 6.4 | Compatible with intended tissues, cells, body fluids | Contact devices | ISO 10993-1 |
| 6.5 | Stable during intended lifetime, not degrading to unsafe levels | All devices | Aging, fatigue, degradation studies |
| 6.6 | Transport and storage stability | All devices | ASTM D4169, real-time/accelerated aging |
| 6.7 | Not compromised by substances in normal use | Applicable devices | Chemical compatibility |
| 7.1 | Devices for delivering/removing substances — specific controls | Delivery/removal devices | Dose accuracy, flow rate testing |
| 7.2 | Substance delivery — flow rate, accuracy, stability | Infusion/injection devices | ISO 8536, ISO 11608 series |
| 7.3 | Substance removal — rate, completeness | Dialysis, filtration devices | Performance testing |
| 7.4 | Environmental properties (traceability, environmental risk) | All devices (consider) | ISO 14001, EU Green Deal considerations |
Infection and Microbiological Properties (GSPR 8–9)
| GSPR | Requirement Summary | Typical Applicability | Key Harmonised Standards |
|---|---|---|---|
| 8.1 | Infection risk minimized (intended use, method of use) | All devices | ISO 14971, ISO 11737 |
| 8.2(a) | Non-reusable devices: single-use only | Single-use devices | ISO 15223-1 symbol requirements |
| 8.2(b) | Reusable devices: validated reprocessing instructions | Reusable devices | ISO 17664 series |
| 8.3 | Sterile devices — validated sterilization method | Sterile devices | ISO 11135, ISO 11137, ISO 17665 |
| 8.4 | Packaging ensures sterility to point of use | Sterile devices | ISO 11607 series |
| 8.5 | Non-sterile devices — maintain microbiological quality | Non-sterile devices | Bioburden testing |
| 8.6 | Microbial ingress protection for devices in use | Devices with fluid pathways | Integrity testing |
| 8.7 | Integral packaging or immediate container | Sterile devices | ISO 11607 |
| 9.1 | Barrier-related (intact skin, mucous membrane) — specific requirements | Barrier devices | ASTM F2100, EN 14683 |
| 9.2 | Blood establishment or blood derivative devices | Blood devices | Regulation (EU) 2017/745 Annex I |
Devices Incorporating Tissues or Substances of Animal Origin (GSPR 10–11)
| GSPR | Requirement Summary | Typical Applicability | Key Harmonised Standards |
|---|---|---|---|
| 10.1 | Conformity with animal tissue requirements (if applicable) | Devices with animal-origin materials | Regulation (EU) 722/2012 |
| 10.2 | Minimize infectious agent transmission | Animal-origin devices | TSE guidelines |
| 10.3 | Treatment, validation, testing of animal-origin materials | Animal-origin devices | ISO 22442 series |
| 10.4 | Nanomaterials — minimize exposure risks | Nanomaterial devices | ISO/TR 10993-22 |
| 11.1 | CMR or endocrine-disrupting substances — specific requirements | Devices with CMR substances | REACH, CLP, ISO 10993-1 |
| 11.2 | Intended to administer/transport medicinal products — specific requirements | Drug-delivery devices | Compatibility, extractables studies |
| 11.3 | Medicinal product incorporation — additional requirements | Combination products | Consultation per Article 1(8) |
Construction and Environmental Properties (GSPR 12–13)
| GSPR | Requirement Summary | Typical Applicability | Key Harmonised Standards |
|---|---|---|---|
| 12.1 | Adjustable or calibrated devices — designed for safe adjustment | Adjustable devices | IEC 60601-1 |
| 12.2 | Controls and indicators clearly visible, labeled | All devices | IEC 60601-1, ISO 15223-1 |
| 13.1 | Safe disposal of waste (substances, sharps) | Applicable devices | IFU instructions |
| 13.2 | Minimize risks to environment during use and disposal | All devices | Environmental risk assessment |
Devices with Diagnostic or Measurement Function (GSPR 14–15)
| GSPR | Requirement Summary | Typical Applicability | Key Harmonised Standards |
|---|---|---|---|
| 14.1 | Measurement function designed for sufficient accuracy, precision, stability | Measuring devices | ISO 15197 (glucose), IEC 60601-2-33 (MRI), etc. |
| 14.2 | Measurements in legal units | Measuring devices | Council Directive 80/181/EEC |
| 14.3 | Accuracy maintained within specified limits under normal conditions | Measuring devices | Accuracy studies |
| 14.4 | Measurement function protected from disturbances | Measuring devices | IEC 60601-1-2 |
| 14.5 | User notified of measurement function malfunction | Measuring devices | Alarm requirements |
| 14.6 | Intended performance maintained under electromagnetic disturbances | Measuring devices | IEC 60601-1-2 |
| 14.7 | Software validated for intended use | Devices with software | IEC 62304, IEC 82304-1 |
| 15.1 | Diagnostic/measuring devices provide sufficient accuracy, precision, stability | Diagnostic devices | ISO 15197, device-specific standards |
| 15.2 | Measurements in legal units | Diagnostic devices | Council Directive 80/181/EEC |
| 15.3 | Assigned range of values, measurement uncertainty, and trueness stated | Diagnostic devices | CLSI EP05, EP06, EP17 |
Protection Against Radiation (GSPR 16–17)
| GSPR | Requirement Summary | Typical Applicability | Key Harmonised Standards |
|---|---|---|---|
| 16.1 | Minimize radiation exposure | Radiation-emitting devices | IEC 60601-1-3 |
| 16.2 | Dose planning and delivery accuracy | Therapeutic radiation devices | IEC 60601-2-1 |
| 16.3 | Ionizing radiation — minimize unintended or scattered radiation | Ionizing devices | IEC 60601-1-3, IEC 60601-2-44 |
| 16.4 | Information for avoiding or reducing radiation exposure | Radiation devices | IFU, dose displays |
| 16.5 | Non-ionizing radiation — minimize unintended exposure | Non-ionizing devices | IEC 60601-2-22 (laser) |
| 17.1 | Software and connected devices — interoperability, security | Software/connectable devices | IEC 62304, IEC 62443, MDCG 2019-16 |
| 17.2 | IT network security, data protection | Connected devices | MDCG 2023-1, IEC 62443 |
| 17.3 | Data migration, backup, recovery | Software devices | IEC 62304 |
Active Devices and Mechanical Risks (GSPR 18–20)
| GSPR | Requirement Summary | Typical Applicability | Key Harmonised Standards |
|---|---|---|---|
| 18.1 | Active devices — safe operation under normal and single-fault conditions | Active devices | IEC 60601-1 |
| 18.2 | Display of settings and status | Active devices | IEC 60601-1 |
| 18.3 | Emergency stop where applicable | Applicable active devices | IEC 60601-1 |
| 18.4 | Protection against electrical risks | Electrically powered devices | IEC 60601-1 |
| 18.5 | Minimize electromagnetic interference | Active devices | IEC 60601-1-2 |
| 18.6 | Electromagnetic immunity | Active devices | IEC 60601-1-2 |
| 18.7 | Battery status indication where applicable | Battery-powered devices | IEC 62133 |
| 18.8 | Alarm systems where applicable | Devices with alarms | IEC 60601-1-8 |
| 19.1 | Labels provide sufficient information for safe use | All devices | ISO 15223-1, ISO 20417 |
| 19.2 | Identification of device and manufacturer on label | All devices | ISO 15223-1 |
| 19.3 | IFU accompanies device or available electronically | All devices | EU MDR Art. 10(11), IFU requirements |
| 19.4 | IFU in language(s) of Member State where device made available | All devices | National language requirements |
| 20.1 | Protection against mechanical risks | All devices | IEC 60601-1, ISO 14971 |
| 20.2 | Minimize vibration risks | Applicable devices | ISO 5349 |
| 20.3 | Minimize noise risks | Applicable devices | ISO 9614 |
| 20.4 | Terminals and connectors safe to handle | Applicable devices | IEC 60601-1 |
Thermal and User-Related Risks (GSPR 21–22)
| GSPR | Requirement Summary | Typical Applicability | Key Harmonised Standards |
|---|---|---|---|
| 21.1 | Minimize risks from high/low temperatures or radiation | Applicable devices | IEC 60601-1 |
| 21.2 | Local heat delivery — controls and monitoring | Thermal devices | IEC 60601-2-35 |
| 22.1 | Ergonomic design for intended user population | All devices | IEC 62366-1, IEC 62366-2 |
| 22.2 | Usability validated for intended users and use environment | All devices | IEC 62366-1 |
Chapter III: Requirements Regarding the Information Supplied with the Device (GSPR 23)
GSPR Evidence Matrix — Chapter III
| GSPR | Requirement Summary | Typical Applicability | Key Harmonised Standards |
|---|---|---|---|
| 23.1 | Information supplied with device identifies manufacturer and device | All devices | ISO 15223-1, ISO 20417 |
| 23.2(a) | UDI on label | All devices (except custom-made) | EU MDR Art. 27 |
| 23.2(b) | Batch/serial number on label | All devices | ISO 15223-1 |
| 23.2(c) | Expiry date or date of manufacture | All devices | ISO 15223-1 |
| 23.2(d) | Storage and handling instructions | All devices | ISO 15223-1 |
| 23.2(e) | Sterile statement and sterilization method | Sterile devices | ISO 15223-1 |
| 23.2(f) | Single-use symbol if applicable | Single-use devices | ISO 15223-1 |
| 23.2(g) | Caution for reprocessing if applicable | Reusable devices | ISO 17664 |
| 23.2(h) | IFU or information on where to obtain IFU | All devices | ISO 20417 |
| 23.2(i) | If applicable: critical warnings, contraindications | All devices | ISO 20417 |
| 23.2(j) | For implantable: card with device identification | Implantable devices | EU MDR Art. 18 |
| 23.2(k) | For implantable: patient implant card information | Implantable devices | EU MDR Art. 18 |
| 23.2(l) | Instructions for device under MDR Art. 1(2) | Applicable devices | EU MDR |
| 23.3 | IFU content requirements (general) | All devices | EU MDR Annex I Section 23.4 |
| 23.4(a) | Intended purpose | All devices | Device description |
| 23.4(b) | Intended user profile | All devices | IEC 62366-1 user profile |
| 23.4(c) | Patient population | All devices | Clinical evidence |
| 23.4(d) | Medical conditions and contraindications | All devices | Clinical evidence, RM file |
| 23.4(e) | Expected clinical benefit | All devices | CER, clinical data |
| 23.4(f) | Performance data (sensitivity, specificity, accuracy, etc.) | All devices | Performance testing |
| 23.4(g) | Risks, undesirable effects, warnings | All devices | RM file, ISO 14971 |
| 23.4(h) | User training requirements | All devices | Training plan |
| 23.4(i) | Clinical evaluation summary methodology | All devices | CER, Annex XIV |
| 23.4(j) | IT network requirements for connected devices | Connected devices | MDCG 2019-16 |
| 23.4(k) | Cybersecurity information | Connected devices | MDCG 2023-1, SBOM |
Cross-Reference: GSPR to Technical File Sections
| GSPR Chapter | Technical File Section (per Annex II) | Key Evidence Documents |
|---|---|---|
| Chapter I (General) | Section 1 (Device description), Section 6 (Risk management) | Risk Management File, Benefit-Risk Analysis |
| GSPR 5–7 (Chemical/Physical) | Section 4 (Manufacturing), Section 5 (Verification/validation) | ISO 10993 reports, Chemical characterization |
| GSPR 8–9 (Infection) | Section 5 (Verification/validation) | Sterilization validation, ISO 17664 report |
| GSPR 10–11 (Substances) | Section 1 (Device description), Section 5 | Toxicological assessment, animal-origin dossier |
| GSPR 14–15 (Measurement) | Section 5 (Verification/validation) | Accuracy/precision studies, calibration data |
| GSPR 16–17 (Radiation/Software) | Section 5 (Verification/validation) | IEC 60601 test reports, IEC 62304 lifecycle docs |
| GSPR 18–20 (Active/Mechanical) | Section 5 (Verification/validation) | IEC 60601 test reports, EMC reports |
| GSPR 21–22 (Thermal/Usability) | Section 5 (Verification/validation) | Thermal testing, usability validation report |
| GSPR 23 (Labeling/IFU) | Section 3 (Labeling) | Label artwork, IFU draft, UDI assignment |
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Status Tracking Dashboard Template
Use this tracking summary at the top of your GSPR checklist to give management and reviewers an at-a-glance view:
| Metric | Target | Current |
|---|---|---|
| Total GSPR sub-requirements | [Count all sub-clauses for your device] | — |
| Applicable | — | [Count] |
| Not Applicable (with rationale) | — | [Count] |
| Compliant | = Applicable | [Count] |
| In Progress | 0 | [Count] |
| Gap (remediation required) | 0 | [Count] |
| Overall compliance % | 100% | [%] |
| Next scheduled review | — | [Date] |
Tips for Notified Body Submissions
Never leave the rationale column blank — even for clearly inapplicable GSPRs, a one-line justification prevents follow-up questions
Use harmonised standard references — referencing specific clauses of harmonised standards creates a presumption of conformity that simplifies review
Link evidence documents directly — use document IDs and section references that match your technical file table of contents
Assign owners — each GSPR should have a named responsible person to ensure accountability and traceability
Track review dates — the GSPR checklist is a living document that must be updated when the device, standards, or regulations change
Address gaps explicitly — a documented gap with a remediation plan is far better than an undocumented gap that a reviewer discovers
Maintain version control — the GSPR checklist should have its own document control header with version history
Cross-reference PMCF — where clinical evidence supports GSPR compliance, link directly to the relevant CER section and PMCF data
Common GSPR Compliance Mistakes
| Mistake | What Notified Bodies Flag | How to Fix |
|---|---|---|
| Blank applicability rationale | "Insufficient justification for N/A determination" | Write a specific reason for every "No" |
| Generic evidence references ("see tech file") | "Unable to locate specific evidence for this GSPR" | Reference exact document ID, section, and page |
| Missing cybersecurity evidence for connected devices | "No SBOM or vulnerability management plan" | Add MDCG 2023-1 documentation for all software/connectable devices |
| No usability validation | "IEC 62366-1 validation report not provided" | Include formative/summative usability study reports |
| Outdated standards | "Referenced standard not harmonised under MDR" | Check latest harmonised standards list (updated periodically by EC) |
| GSPR 10.4 (nanomaterials) ignored for devices with coatings | "Nanomaterial assessment not provided" | Assess all coatings and surface treatments for nanoscale components |
| No cross-reference to risk management | "GSPR compliance disconnected from risk file" | Link risk control measures to specific GSPR requirements |
Recommended Reading
ISO 20417:2026 Guide: FDA Rec# 5-149, July 1 2029 DoC Window & ISO 15223-1
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Key References
| Document | Description |
|---|---|
| Regulation (EU) 2017/745, Annex I | Full text of all 23 GSPR |
| Regulation (EU) 2017/745, Annex II | Technical documentation structure |
| MDCG 2020-5 | Clinical evidence — equivalence |
| MDCG 2019-16 | Cybersecurity for medical devices |
| MDCG 2023-1 | Cybersecurity expectations (2026 update) |
| ISO 14971:2019 | Risk management |
| ISO 10993-1 | Biocompatibility evaluation |
| ISO 15223-1 | Symbols for labels and labeling |
| ISO 20417:2026 | Information to be supplied by manufacturer (FDA Rec# 5-149; not currently an OJEU-cited harmonised standard — see ISO 20417:2026 operating guide) |
| ISO 17664 series | Reprocessing instructions |
| IEC 62304:2006/Amd 1:2015 | Software lifecycle |
| IEC 62366-1:2015/Amd 1:2020 | Usability engineering |
| IEC 60601-1:2005/A2:2020 | General requirements for active devices |
Sources: Regulation (EU) 2017/745 Annex I (GSPR full text); Greenlight Guru GSPR Checklist Template methodology; OpenRegulatory GSPR Checklist Template structure; Qualio GSPR Checklist framework; MDCG 2020-5, 2019-16, 2023-1 guidance documents; EU MDR Annex II technical documentation requirements; ISO 14971:2019, ISO 10993-1:2018, IEC 62304:2006, IEC 62366-1:2015.