Updated: 24th June 2026
Reviewed by: David Small BSc (Hons), MSc, MTOPRA (Founder & CEO)
Why EU MDR GSPRs Matter
This comprehensive guide explores what the GSPRs are, why they matter, and how manufacturers can ensure full compliance—helping you avoid costly delays, reduce regulatory risk, and bring safe, effective devices to the EU market.
New to the EU MDR?
GSPRs form the foundation of medical device safety and performance under Regulation (EU) 2017/745. For a complete overview of MDR requirements, including classification, Article 10 obligations, clinical evaluation, technical documentation, UDI, EUDAMED and CE marking, explore our EU MDR for Beginners Guide.
What Are the GSPRs?
The General Safety and Performance Requirements (GSPRs) are a detailed set of criteria that medical devices must meet to be legally placed on the EU market. They effectively replace the Essential Requirements (ERs) that were part of the MDD. The GSPRs are more rigorous and more comprehensive, reflecting the EU’s intent to enhance patient safety, device performance, and regulatory oversight.
The GSPRs are divided into three main chapters:
Chapter I: General Requirements
Focuses on overall safety, risk-benefit balance, and performance.
Includes requirements for risk management systems, usability, and compatibility.
Chapter II: Requirements Regarding Design and Manufacture
Covers biocompatibility, sterilisation, software validation, packaging, and more.
Includes special attention to devices containing substances that are carcinogenic, mutagenic, or toxic to reproduction (CMR).
Chapter III: Requirements Regarding Information Supplied with the Device
Addresses labeling, instructions for use (IFU), and transparency.
Requires all information to be understandable, accessible, and consistent.
Each requirement must be assessed for every device to ensure compliance. The goal is to ensure that devices are not only functional but safe under all intended conditions of use.
Why Are GSPRs Important?
Compliance with the GSPRs is not optional—it is mandatory. Failing to meet these requirements can result in rejected conformity assessments, product recalls, or inability to access the EU market. But beyond regulatory penalties, GSPRs are essential because they:
Ensure Patient Safety: By setting high standards, GSPRs help minimize the risk of harm to users and patients.
Support Device Performance: They ensure the product works as intended, across its entire lifecycle.
Enhance Market Confidence: Devices that comply with GSPRs are seen as more trustworthy by healthcare providers, users, and regulators.
Facilitate Global Trade: Many elements of the GSPRs align with international standards such as ISO 13485 and ISO 14971, making it easier to access markets outside the EU.
Key Steps to Ensure GSPR Compliance
Meeting the GSPRs requires a systematic, well-documented approach. Here are the essential steps medical device manufacturers should follow:
1. Conduct a Thorough Risk Assessment
Risk management is a central requirement of the GSPRs. Manufacturers must:
Implement a risk management system compliant with ISO 14971.
Identify hazards associated with the device.
Evaluate risks and benefits.
Implement risk controls and monitor their effectiveness throughout the device lifecycle.
Understanding Risk Management Under the EU MDR?
Risk management is at the heart of the General Safety and Performance Requirements (GSPRs). Discover how ISO 14971 helps manufacturers identify hazards, evaluate and control risks, demonstrate benefit-risk, and maintain a compliant Risk Management File throughout the medical device lifecycle.
2. Develop and Maintain a Robust Quality Management System (QMS)
A QMS aligned with ISO 13485 is critical for demonstrating GSPR compliance. Your QMS should include:
Design and development controls.
Supplier management.
Production and process control.
Complaint handling and post-market surveillance.
Implementing an ISO 13485 Quality Management System?
A robust Quality Management System forms the foundation of successful EU MDR compliance. Learn how ISO 13485 supports General Safety and Performance Requirements (GSPRs) through effective design controls, risk management, document control, supplier management and continual improvement throughout the medical device lifecycle.
3. Compile Detailed Technical Documentation
Your technical documentation must provide objective evidence that the device meets all relevant GSPRs. This includes:
Design specifications and drawings.
Clinical evaluation reports.
Verification and validation data.
Risk management documentation.
Labeling and user information.
This documentation should follow the structure outlined in Annex II and III of the MDR.
Building Your Technical Documentation?
A compliant GSPR checklist is only one part of your EU MDR technical documentation. Discover How to Structure a Medical Device Technical File to learn how Annex II documentation should be organised, including device descriptions, risk management, clinical evaluation, verification and validation, and post-market surveillance evidence. :contentReference[oaicite:0]{index=0}
4. Provide Accurate and Clear Labeling and Instructions for Use
Chapter III of the GSPRs outlines requirements for the information supplied with the device. Ensure:
Labeling is legible, durable, and includes all required symbols and warnings.
Instructions for use are clear, comprehensive, and understandable by intended users.
Electronic IFUs (eIFUs) are compliant with relevant EU regulations if applicable.
Need Help with Medical Device Labelling?
Compliant labelling is a key requirement of the EU MDR General Safety and Performance Requirements (GSPRs). Learn how Medical Device Labelling supports regulatory compliance through correct symbols, UDI, manufacturer information, warnings, Instructions for Use (IFU) and Annex I labelling requirements.
5. Address Specific Device Types and Special Requirements
Certain types of devices have additional requirements, such as:
Devices incorporating medicinal substances.
Devices containing nanomaterials.
Devices that are implantable or active.
Make sure you understand any additional GSPRs that may apply based on your device’s classification and intended use.
6. Conduct a GSPR Checklist Assessment
Many manufacturers use a GSPR checklist to methodically address each requirement. For each GSPR:
State whether it is applicable.
Provide a justification if it is not applicable.
Offer objective evidence of compliance where it is applicable.
A well-maintained GSPR checklist is essential for a successful conformity assessment with your Notified Body.
Looking for the Complete GSPR Checklist?
This guide explains how to demonstrate compliance with the EU MDR General Safety and Performance Requirements. If you need a requirement-by-requirement breakdown of Annex I, explore our comprehensive EU MDR GSPRs Checklist and Compliance Guide, including practical explanations, applicability and evidence requirements for each General Safety and Performance Requirement.
7. Engage with a Notified Body Early
If your device requires Notified Body involvement, engage early in the process. Submit:
Technical documentation.
GSPR checklist.
Clinical data and risk assessments.
Their feedback can help identify gaps early, reducing delays during the conformity assessment process.
Preparing for Notified Body Review?
A well-prepared GSPR checklist is a key part of every successful EU MDR conformity assessment. Learn how Notified Bodies assess technical documentation, review General Safety and Performance Requirements (GSPRs), and identify common reasons for delays or non-conformities during CE marking.
Worked Example: Demonstrating Compliance with GSPR 10 – Chemical, Physical and Biological Properties
One of the most common challenges for manufacturers is demonstrating how each applicable General Safety and Performance Requirement has been addressed within the technical documentation. The example below illustrates how a manufacturer might complete part of a GSPR checklist for a reusable surgical instrument.
Example Device
Reusable stainless steel surgical forceps intended for use during general surgical procedures.
| GSPR | Applicability | Evidence | Technical Documentation Reference |
|---|---|---|---|
| GSPR 10 – Chemical, Physical and Biological Properties | Applicable | Material specification confirming medical-grade stainless steel; Biological Evaluation Report prepared in accordance with ISO 10993; Supplier material certificates; Risk Management File assessing biocompatibility risks | Section 3 – Device Description; Section 8 – Biological Evaluation; Section 10 – Risk Management |
| Justification | The device has prolonged contact with intact tissue. Biological evaluation confirms that the selected materials are suitable for the intended clinical use and no unacceptable biological risks remain after implementation of risk controls. |
Need to Demonstrate Biological Safety?
Many General Safety and Performance Requirements require manufacturers to demonstrate biological safety using objective evidence. Learn how Biological Evaluation for Medical Devices supports EU MDR compliance through ISO 10993, biocompatibility assessments and biological risk management.
Key Learning Points
When completing a GSPR checklist, manufacturers should avoid simply writing “Compliant” or “Meets Requirement”. Instead, every applicable requirement should be supported by objective evidence contained within the technical documentation.
A robust GSPR checklist should:
- Confirm whether each requirement is applicable.
- Explain why a requirement is applicable (or not applicable).
- Reference the exact supporting reports and technical documentation.
- Demonstrate traceability between the GSPR, risk management activities and verification evidence.
- Be maintained throughout the product lifecycle as the device or supporting evidence changes.
By taking this approach, manufacturers can demonstrate to their Notified Body or Competent Authority that compliance has been systematically assessed rather than assumed.
Common Sources of Evidence Used to Demonstrate GSPR Compliance
Although every medical device is different, manufacturers typically rely on a combination of technical documentation, testing reports and quality management system records to demonstrate compliance with the General Safety and Performance Requirements. The table below provides examples of the evidence commonly used for different areas of Annex I.
| GSPR Area | Typical Evidence | Relevant Standard or Regulation |
|---|---|---|
| Risk Management | Risk Management Plan, Risk Analysis, Risk Management Report | EN ISO 14971 |
| Design and Manufacture | Design inputs, design outputs, design verification and validation records | ISO 13485 |
| Biological Safety | Biological Evaluation Plan, Biological Evaluation Report, ISO 10993 test reports | EN ISO 10993 Series |
| Clinical Performance | Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER), PMCF data | MDR Article 61 & Annex XIV |
| Software Safety | Software development file, verification testing, cybersecurity documentation | IEC 62304 |
| Usability | Usability Engineering File, formative and summative usability studies | IEC 62366-1 |
| Electrical & Mechanical Safety | Electrical safety testing, EMC reports, performance testing, verification reports | IEC 60601 Series (where applicable) |
| Labelling & Instructions for Use | Device labels, Instructions for Use (IFU), symbols, artwork approval records | MDR Annex I & EN ISO 15223-1 |
| Sterility & Packaging | Sterilisation validation, packaging validation, shelf-life and transport validation reports | ISO 11135, ISO 11137, ISO 11607 (as applicable) |
| Post-Market Surveillance | PMS Plan, PMS Report, PMCF Plan, PMCF Evaluation Report, Vigilance records | MDR Articles 83–86 |
Developing a New Medical Device?
Compliance with the General Safety and Performance Requirements (GSPRs) begins during product development, not after design is complete. Explore our guide to Medical Device Design and Development to learn how design controls, user needs, verification, validation and risk management support successful EU MDR compliance from concept to market.
Designing Devices That Are Safe and Easy to Use?
Many EU MDR General Safety and Performance Requirements (GSPRs) focus on reducing use-related risks through good design. Learn how IEC 62366-1 Usability Engineering helps manufacturers identify user needs, minimise use errors, validate user interfaces and demonstrate compliance through a comprehensive Usability Engineering File (UEF).
Need to Demonstrate Clinical Safety and Performance?
Clinical evaluation is a fundamental requirement for demonstrating compliance with the EU MDR General Safety and Performance Requirements (GSPRs). Discover how Medical Device Clinical Evaluation supports CE marking through Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), literature reviews, benefit-risk assessment and ongoing clinical evidence throughout the device lifecycle.
Developing Medical Device Software?
Software used in or as a medical device must also comply with the EU MDR General Safety and Performance Requirements (GSPRs). Learn how IEC 62304 supports compliant software development through lifecycle planning, software safety classification, verification, validation, cybersecurity and ongoing maintenance for embedded software and Software as a Medical Device (SaMD).
Key Takeaway
Manufacturers should not rely on a single document to demonstrate compliance with the General Safety and Performance Requirements. Instead, each applicable GSPR should be supported by objective evidence that can be traced directly to the relevant section of the technical documentation. A well-structured GSPR checklist links every requirement to the supporting reports, standards and quality management records, making it easier for Notified Bodies and Competent Authorities to verify compliance during conformity assessment.
Common Pitfalls in GSPR Compliance
Avoid these common mistakes to ensure a smoother path to compliance:
Underestimating the Scope: Manufacturers sometimes think GSPRs only apply to the design stage. In reality, they apply throughout the product lifecycle.
Weak Risk Management Files: Incomplete or poorly justified risk files can lead to non-compliance.
Lack of Justification for Non-Applicability: Simply stating “not applicable” is not enough. You must provide a clear rationale.
Inconsistent Documentation: Ensure consistency between your labeling, IFU, technical file, and risk documentation.
Frequently Asked Questions About The EU MDR GSPRs
The General Safety and Performance Requirements (GSPRs) are the essential safety and performance criteria set out in Annex I of Regulation (EU) 2017/745 (EU MDR). Every medical device placed on the European market must demonstrate compliance with all applicable GSPRs before it can receive CE marking. Manufacturers are required to document this compliance within their technical documentation using a GSPR checklist.
No. Not every requirement in Annex I applies to every medical device. Manufacturers must assess each GSPR individually, determine whether it is applicable to their device and provide a clear justification where a requirement is considered not applicable. This assessment should be documented within the GSPR checklist.
Compliance should be supported by objective evidence contained within the technical documentation. This may include risk management files, clinical evaluation reports, biological evaluation reports, verification and validation testing, software documentation, usability engineering files, labelling, Instructions for Use (IFU) and post-market surveillance records. The evidence required will depend on the device and its intended purpose.
Yes. Manufacturers are expected to prepare and maintain a General Safety and Performance Requirements checklist as part of their technical documentation. The checklist demonstrates how each applicable requirement has been addressed and provides traceability to the supporting evidence reviewed by the Notified Body or Competent Authority.
Several harmonised and internationally recognised standards support compliance with the GSPRs, including EN ISO 14971 for risk management, EN ISO 13485 for quality management systems, EN ISO 10993 for biological evaluation, IEC 62304 for medical device software and IEC 62366-1 for usability engineering. Manufacturers should select standards that are relevant to their specific device.
The GSPR checklist should be reviewed and updated whenever there are significant changes to the device, its intended purpose, design, manufacturing process, applicable standards or regulatory requirements. It should also be reviewed as part of ongoing post-market surveillance activities to ensure the technical documentation remains current throughout the product lifecycle.
Yes. A Notified Body may raise non-conformities if the GSPR checklist is incomplete, lacks objective evidence, contains insufficient justifications or cannot demonstrate traceability to the supporting technical documentation. A well-prepared checklist is essential for a successful conformity assessment under the EU MDR.
Yes. Class I medical devices must also demonstrate compliance with the applicable General Safety and Performance Requirements. Although most Class I devices are self-certified, manufacturers are still required to maintain technical documentation, including a GSPR checklist, and make it available to Competent Authorities upon request.
The Role of Patient Guard in GSPR Compliance
Navigating EU MDR compliance can be overwhelming—especially when it comes to the detailed expectations of the GSPRs. At Patient Guard, we provide expert regulatory support to help you:
Perform GSPR gap assessments.
Compile compliant technical documentation.
Conduct risk management and clinical evaluations.
Liaise with Notified Bodies.
Our team of regulatory experts has helped hundreds of clients bring their devices to the EU market with confidence.
Summary
The General Safety and Performance Requirements are a cornerstone of the EU MDR. They are designed to protect patients, ensure performance, and raise the bar for device quality across the EU.
Achieving compliance isn’t just about ticking boxes. It requires a strategic, structured approach across your organisation—from R&D to post-market surveillance. With the right preparation and expert guidance, you can meet these requirements efficiently and bring your device to market successfully.
Need help navigating GSPR compliance? Contact Patient Guard today for regulatory support tailored to your medical device and market goals.
References
This guide is based on the following legislation, international standards and official regulatory guidance relating to the General Safety and Performance Requirements (GSPRs) under Regulation (EU) 2017/745 (MDR).
| Organisation | Reference | Why it's relevant |
|---|---|---|
| European Union | Regulation (EU) 2017/745 on Medical Devices (MDR) | Contains Annex I, which sets out the General Safety and Performance Requirements (GSPRs) that every medical device must satisfy before being placed on the European market. |
| European Commission | MDCG Endorsed Documents and Other Guidance | Provides official Medical Device Coordination Group (MDCG) guidance supporting implementation of the GSPRs, technical documentation, clinical evaluation, post-market surveillance and conformity assessment under the MDR. |
| European Commission | Notified Bodies for Medical Devices | Provides official information on the role and responsibilities of Notified Bodies responsible for assessing conformity with the MDR, including compliance with the General Safety and Performance Requirements. |
| International Organization for Standardization (ISO) | ISO 13485:2016 – Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes | Defines the internationally recognised Quality Management System requirements that support manufacturers in implementing and maintaining processes necessary to demonstrate compliance with the MDR GSPRs. |
| International Organization for Standardization (ISO) | ISO 14971:2019 – Medical Devices – Application of Risk Management to Medical Devices | Provides the internationally recognised framework for risk management, supporting the identification, evaluation and control of risks as required throughout Annex I of the MDR. |
The General Safety and Performance Requirements, recognised standards and regulatory guidance continue to evolve. Manufacturers should always consult the latest published legislation, recognised standards and official guidance when demonstrating compliance with Annex I of Regulation (EU) 2017/745.
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