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GSPR Chapter I — General requirements

Regulatory basis

MDR 2017/745, Annex I, Chapter I (GSPR 1–5) and equivalent provisions in IVDR 2017/746, Annex I, Chapter I. These requirements are foundational — they apply to every device regardless of type or class.

Disclaimer

This site provides general information only and does not constitute legal or regulatory advice. Always consult the official regulation text and a qualified regulatory professional.

Overview​

Chapter I of Annex I sets out the overarching principles that govern all medical devices. They establish:

  1. The fundamental safety obligation
  2. The risk management requirement
  3. The performance requirement
  4. Design, manufacture, and packaging obligations
  5. The state-of-the-art obligation

Every subsequent GSPR in Chapters II and III flows from these foundational requirements.

GSPR 1 — Fundamental safety principle​

Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. They shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of health protection and safety.

What this requires in practice​

  • The device must perform as claimed under the conditions of use described in the intended purpose
  • Risks must be acceptable — not zero, but weighed against benefit
  • The risk-benefit balance is assessed from the patient's perspective (not the manufacturer's commercial interest)
  • The standard is not absolute safety but acceptable risk at a level compatible with high health protection

This is the foundation of the EU's risk-benefit approach to medical device regulation.

GSPR 2 — Risk management​

The solutions adopted by the manufacturer for the design and manufacture of the devices shall conform to safety principles, taking account of the generally acknowledged state of the art.

For the purposes of reducing risk, the manufacturer shall manage risks so that the residual risk associated with each hazard as well as the overall residual risk is judged acceptable.

The required risk reduction hierarchy is:

  1. Eliminate or reduce risks as far as possible through inherent safe design and manufacture
  2. Where residual risks cannot be eliminated, take adequate protective measures including alarms
  3. Provide information for safety (warnings, precautions, contraindications in labelling and IFU)

Risk management standard​

The harmonised standard EN ISO 14971:2019 (Application of risk management to medical devices) provides the operational framework for GSPR 2 compliance. Key elements:

ElementDescription
Risk management planDocuments scope, responsibilities, and criteria for risk acceptability
Hazard identificationSystematic identification of all foreseeable hazards and hazardous situations
Risk estimationProbability of harm × severity of harm
Risk evaluationComparison against acceptability criteria
Risk controlSelection and implementation of controls in priority order
Residual risk evaluationIs the residual risk after controls acceptable?
Overall risk-benefitIs the overall residual risk acceptable in light of clinical benefit?
Production and post-productionRisk management continues throughout the device lifecycle

The risk management file is a living document and must be updated as PMS data accumulates post-market.

GSPR 3 — Performance under conditions of use​

Devices shall be designed, manufactured, and packaged in such a way that their characteristics and performance during their intended use are not adversely affected under transport and storage conditions (for example, fluctuations of temperature and humidity), taking account of the instructions and information provided by the manufacturer.

Implications​

  • Stability and shelf-life must be established and validated
  • Transport and storage conditions (temperature, humidity, vibration, pressure) must be defined and tested
  • Performance degradation over the stated shelf-life must be within acceptable limits
  • Accelerated ageing studies are commonly used to support shelf-life claims

GSPR 4 — Design, manufacture, and packaging​

The known and foreseeable risks, and any unacceptable adverse effects, shall be minimised while ensuring a positive benefit-risk ratio for the device through proper design, manufacture and the provision of adequate information.

This GSPR bridges the general principles of GSPR 1–3 with the specific design and construction requirements of Chapter II. It requires:

  • Foreseeable misuse is considered in design (not just intended use)
  • Packaging is designed to maintain device integrity and sterility (if applicable) throughout the stated shelf life and transport conditions
  • Design decisions are documented and justified in technical documentation

GSPR 5 — State of the art​

Devices shall achieve the performance intended by their manufacturer.

This seemingly simple requirement encompasses the obligation to take into account the generally acknowledged state of the art — current scientific knowledge, clinical evidence, and technical capability — when designing and manufacturing a device.

Manufacturers cannot justify a suboptimal design by claiming they lacked knowledge that was available in the scientific literature. The state of the art:

  • Is not defined by the most advanced research, but by what is generally acknowledged in the relevant field
  • Evolves over time — technical documentation must be updated to remain current
  • Is assessed at the time of design and at each subsequent review/update

The interaction between GSPR 1–5​

These five requirements work together:

GSPR 5: State of the art informs what is achievable
         ↓
GSPR 2: Risk management identifies and controls hazards
         ↓
GSPR 1: The residual risk-benefit is acceptable
         ↓
GSPR 3 & 4: Design, manufacture, and packaging realise
             the safe, effective device

A failure at any level cascades. A manufacturer who does not follow the state of the art (GSPR 5) cannot demonstrate adequate risk management (GSPR 2), cannot guarantee performance (GSPR 3), and ultimately cannot meet the fundamental safety principle (GSPR 1).

Official references​

ReferenceDescription
MDR Annex I, Chapter IGSPR 1–5 (full text)
IVDR Annex I, Chapter IEquivalent IVDR provisions
EN ISO 14971:2019Risk management for medical devices
MDCG 2022-14Guidance on GSPR application