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General Safety & Performance Requirements — Annex I overview

Applies to

Both MDR 2017/745 and IVDR 2017/746. Each regulation contains its own Annex I (GSPR), with mostly parallel structure and some IVDR-specific elements.

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.

What are the GSPR?​

The General Safety and Performance Requirements (GSPR) in Annex I are the fundamental technical and clinical requirements that every medical device and IVD must meet before it can bear a CE mark. They are the EU equivalent of what other systems call "essential requirements" or "essential principles."

Meeting the GSPR is not optional — it is the central legal obligation on manufacturers. The CE mark declaration of conformity is, at its core, a manufacturer's statement that all applicable GSPR have been met.

Structure of Annex I​

Annex I of both MDR and IVDR is divided into three chapters:

ChapterContentPages in this site
Chapter I — General RequirementsFundamental safety obligations — that devices are safe, perform as intended, and risks are acceptableChapter I — General requirements
Chapter II — Requirements Regarding Design and ManufactureSpecific technical requirements for how devices are designed, constructed, and validatedChapter II — Design & construction
Chapter III — Requirements Regarding the Information Supplied with the DeviceLabelling, instructions for use (IFU), and symbolsChapter III — IFU & labelling

The 23 GSPR at a glance (MDR)​

MDR Annex I contains 23 GSPR (IVDR has the same structure with some modified requirements):

Chapter I — General Requirements​

  1. Devices shall not compromise clinical condition or safety of patients (general safety principle)
  2. Risk management — risks shall be eliminated or reduced as far as possible; risk-benefit acceptable
  3. Devices shall achieve intended performance during normal conditions of use
  4. Devices shall be designed, manufactured, and packaged appropriately
  5. State-of-the-art shall be taken into account

Chapter II — Design & Manufacture (selected GSPR)​

  1. Chemical, physical, and biological properties
  2. Infection and microbial contamination
  3. Devices incorporating a medicinal substance
  4. Devices manufactured from tissues or cells of human or animal origin
  5. Devices incorporating CMR substances or endocrine disruptors
  6. Interaction with the environment
  7. Devices with a measuring function
  8. Protection against radiation
  9. Requirements for medical devices connected to or equipped with an energy source
  10. Protection against mechanical and thermal risks
  11. Protection against risks posed to the patient or user from energy supplied or emitted
  12. Protection against risks posed by medical devices intended for self-testing or near-patient testing
  13. Electromagnetic disturbance — protection from and emission of
  14. Protection against mechanical risks (continued)
  15. Devices intended to be used in combination with other devices or equipment
  16. Requirements for devices incorporating software or software that are devices in themselves
  17. Active devices and their connection to patients
  18. Particular requirements for active implantable devices

Chapter III — Information supplied​

The IFU, labelling, and symbols requirements are set out in a single section of Chapter III.

"Applicable" GSPR — the key concept​

Not all 23 GSPR apply to every device. The manufacturer must determine which GSPR are applicable based on the device's:

  • Intended purpose
  • Device type and technology
  • Intended users (patient, layperson, professional)
  • Conditions of use

A simple wound dressing will have far fewer applicable GSPR than an active implantable device. The technical documentation must include a GSPR cross-reference table documenting:

  • Which GSPR apply
  • Which GSPR are not applicable (and why)
  • For each applicable GSPR: how conformity is demonstrated (harmonised standard, common specification, or other means)

How GSPR conformity is demonstrated​

There are three routes to demonstrating GSPR compliance:

1. Harmonised European standards​

If a harmonised standard fully covers a GSPR, and the manufacturer complies with it, a presumption of conformity applies for that GSPR. This is the most efficient route.

Examples:

  • EN ISO 14971:2019 → GSPR 1 and 2 (risk management)
  • EN ISO 10993-1:2018 → GSPR 10 (biological safety)
  • EN 62304:2006+A1:2015 → GSPR 17 (software)
  • EN ISO 15223-1 → Chapter III labelling requirements

2. Common Specifications (CS)​

Where the Commission has published Common Specifications covering specific GSPR or device categories, compliance with the CS also creates a presumption of conformity. Manufacturers may depart from a CS but must document the justification and demonstrate equivalent or better conformity.

3. Alternative solutions​

Manufacturers may demonstrate GSPR compliance without using harmonised standards or CS — through test reports, clinical evidence, scientific literature, or other documented means. The burden of proof is on the manufacturer.

Risk management is the backbone​

GSPR 1 and 2 (Chapter I) — the general safety principle and the risk management requirement — underpin every other GSPR. The risk management process (following EN ISO 14971) must:

  • Identify all hazards associated with the device
  • Estimate the associated risks
  • Evaluate the risks against acceptability criteria
  • Implement risk controls (in priority order: inherent safety by design → protective measures → information for safety)
  • Verify residual risks are acceptable
  • Consider the overall residual risk in light of clinical benefit

The risk management file is a living document — it must be updated throughout the device lifecycle.

GSPR for IVDs — key differences​

IVDR Annex I largely mirrors MDR Annex I, but with modifications for the in vitro context:

  • References to specimen handling and contamination rather than patient contact
  • Specific requirements for measuring function accuracy and precision (traceability to SI units where applicable)
  • Requirements for near-patient testing and self-testing interfaces
  • IFU requirements specific to IVDs (expected values, interference, limitations)

Official references​

ReferenceDescription
MDR Annex IFull GSPR text (23 requirements)
IVDR Annex IIVDR equivalent GSPR
MDR Art. 5(2)Presumption of conformity from harmonised standards
MDR Art. 9Common Specifications
EN ISO 14971:2019Risk management
MDCG 2022-14Guidance on the GSPR