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Summary

You must systematically evaluate your medical device against all General Safety and Performance Requirements (GSPR) in EU MDR Annex I to demonstrate comprehensive compliance with essential safety and performance standards. This structured checklist provides systematic assessment of each requirement’s applicability, identifies relevant standards, documents compliance evidence, and justifies any deviations from standard approaches.

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Regulatory Context

  • FDA
  • MDR
Under 21 CFR Part 820 (Quality System Regulation), comparable assessments include:
  • Design controls compliance per Section 820.30 ensuring systematic safety evaluation
  • Risk analysis documentation per design control requirements
  • Standards compliance verification for FDA-recognized consensus standards
  • 510(k) submission requirements for substantial equivalence demonstration
  • Essential performance validation per applicable FDA guidance documents
Special attention required for:
  • Software validation per FDA software guidance documents and standards
  • Cybersecurity requirements per FDA premarket cybersecurity guidance
  • Usability engineering per FDA Human Factors guidance requirements
  • Predicate device comparison for demonstrating substantial equivalence

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Overview

The General Safety and Performance Requirements Checklist serves as the comprehensive compliance verification tool that systematically demonstrates your medical device meets all applicable EU MDR essential requirements through structured evaluation, evidence documentation, and transparent justification of compliance approaches. This critical assessment transforms regulatory requirements into actionable compliance verification while providing regulatory authorities with clear evidence of systematic safety and performance consideration. GSPR Checklist Structure and Application follows the systematic organization of EU MDR Annex I requirements including General Requirements (GSPRs 1-9), Design and Manufacturing Requirements (GSPRs 10-22), and Information Requirements (GSPR 23). The checklist application process requires careful evaluation of each requirement’s applicability to your specific device based on intended use, design characteristics, and risk profile while ensuring that all applicable requirements receive appropriate attention and compliance verification. Systematic application includes determination of requirement applicability through device-specific analysis, identification of applicable harmonized standards that provide compliance pathways, and documentation of objective evidence that demonstrates conformity with each applicable requirement. Applicability Assessment and Justification ensures that each GSPR requirement receives appropriate consideration through systematic evaluation of device characteristics, intended use, and design features that determine requirement relevance. Applicability assessment requires careful analysis of device functionality and characteristics to determine which requirements apply, consideration of intended use and user population to assess relevance of specific safety and performance requirements, and evaluation of device design and technology to determine applicable technical requirements. Clear justification must be provided for any requirements marked as not applicable, including device-specific technical reasoning that explains why certain requirements don’t apply to your device design or intended use. Harmonized Standards Identification and Application provides systematic pathways to GSPR compliance through application of recognized technical standards that provide presumption of conformity with essential requirements. Standards identification requires reference to the Official Journal of the European Union for current harmonized standards, selection of standards that address your device’s specific technical characteristics and safety requirements, and documentation of how standards application supports compliance with specific GSPR requirements. Key standards for software medical devices include EN 62304 for software lifecycle processes, IEC 82304-1 for health software requirements, EN ISO 14971 for risk management, and EN 62366-1 for usability engineering. Evidence Documentation and Traceability establishes clear connections between GSPR requirements and objective evidence that demonstrates compliance through systematic documentation and cross-referencing. Evidence documentation requires identification of specific documents from your technical file that provide compliance evidence, clear description of how evidence addresses specific GSPR requirements, and establishment of traceability links between requirements, evidence, and compliance conclusions. Evidence must be current, relevant, and sufficient to support compliance claims while enabling independent verification by regulatory authorities and notified bodies. Software-Specific GSPR Compliance addresses the unique requirements for software medical devices including software development lifecycle compliance, cybersecurity considerations, and user interface requirements. Software GSPR compliance requires particular attention to GSPR 17 requirements for electronic programmable systems including software development according to recognized lifecycle standards, risk management including cybersecurity risk assessment, and verification and validation of software performance and safety. Additional software considerations include GSPR 18.8 requirements for protection against unauthorized access, mobile platform considerations if applicable, and integration with network security requirements. Risk Management Integration ensures that GSPR compliance assessment aligns with systematic risk management activities while demonstrating that identified risks have been appropriately controlled and residual risks are acceptable. Risk management integration requires demonstration of how risk analysis findings support GSPR compliance, evidence that risk controls address GSPR requirements where applicable, and documentation of how GSPR compliance contributes to overall benefit-risk assessment. Integration activities ensure that GSPR compliance and risk management activities reinforce each other while providing comprehensive safety evidence. Clinical Evaluation Alignment verifies that GSPR compliance claims are supported by appropriate clinical evidence and that clinical evaluation conclusions support GSPR compliance assertions. Clinical alignment requires confirmation that clinical evaluation addresses GSPR requirements where applicable, evidence that clinical data supports performance claims made in GSPR compliance, and demonstration that benefit-risk analysis supports GSPR compliance conclusions. Effective alignment ensures that technical compliance and clinical evidence provide consistent and mutually supportive safety and performance evidence. Post-Market Surveillance Integration establishes connections between GSPR compliance verification and ongoing post-market monitoring activities that ensure continued compliance throughout the device lifecycle. Surveillance integration requires identification of GSPR requirements that require ongoing monitoring, establishment of post-market procedures that monitor continued compliance with applicable requirements, and implementation of change control procedures that address GSPR implications of device modifications. Effective integration ensures that GSPR compliance remains valid throughout the commercial device lifecycle. Documentation Quality and Regulatory Review Preparation ensures that GSPR checklist documentation meets regulatory standards for clarity, completeness, and regulatory review efficiency. Documentation quality requirements include clear and specific compliance statements that avoid generic or vague assertions, comprehensive evidence references that enable independent verification, and logical organization that facilitates regulatory and notified body review. Quality documentation prevents regulatory queries while enabling efficient compliance assessment and approval processes. Continuous Compliance Monitoring and Updates establishes procedures for maintaining GSPR compliance currency throughout the device lifecycle including updates for device changes, regulatory evolution, and new evidence availability. Compliance monitoring includes systematic review of GSPR compliance when device changes are implemented, monitoring of regulatory guidance updates that may affect compliance approaches, and procedures for updating compliance documentation when new evidence becomes available. Effective monitoring ensures that GSPR compliance remains current and accurate while supporting ongoing regulatory obligations and commercial success. Your GSPR Checklist activities must demonstrate systematic compliance verification with all applicable EU MDR essential requirements while providing transparent, evidence-based documentation that supports confident regulatory approval and ongoing market authorization. Well-executed GSPR compliance verification provides regulatory authorities with clear evidence of comprehensive safety and performance consideration, enables efficient regulatory review and approval processes, and establishes the compliance foundation for successful long-term market presence through demonstrated adherence to essential safety and performance requirements.