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GSPR Chapter II — Requirements regarding design and manufacture

Regulatory basis

MDR 2017/745, Annex I, Chapter II (GSPR 6–22) and equivalent provisions in IVDR 2017/746, Annex I, Chapter II. These are specific technical requirements for how devices must be designed and manufactured.

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 II translates the general principles of Chapter I into specific technical requirements. The applicable GSPR will vary significantly by device type — a passive wound dressing has far fewer applicable Chapter II requirements than an active implantable device.

GSPR 6 — Chemical, physical, and biological properties​

Devices must be designed and manufactured such that:

  • The choice of materials considers toxicity, biocompatibility, and suitability for function
  • Materials are compatible with biological tissues, cells, and body fluids they contact
  • Leachables and extractables are minimised and within acceptable limits
  • Nanomaterials are specifically addressed where used

The key harmonised standard is the EN ISO 10993 series (Biological evaluation of medical devices), which includes:

  • ISO 10993-1: Evaluation and testing within a risk management process
  • ISO 10993-3: Tests for genotoxicity
  • ISO 10993-5: Tests for in vitro cytotoxicity
  • ISO 10993-10: Tests for skin sensitisation
  • ISO 10993-12: Sample preparation and reference materials

For devices with medicinal substance components, additional pharmaceutical standards apply.

GSPR 7 — Infection and microbial contamination​

Devices and their manufacturing processes must be designed to:

  • Reduce the risk of infection to the patient, user, and third parties
  • Facilitate handling of contaminated devices safely (e.g. sharps)
  • Clearly state the intended microbial state (sterile, clean, or unspecified)

For sterile devices:

  • Must be manufactured and sterilised by an appropriate validated method
  • The validated sterility assurance level (SAL) must be ≤ 10⁻⁶ for implantable devices
  • Packaging must maintain sterility until point of use

Key standards: EN ISO 11135 (sterilisation by EtO), EN ISO 11137 (radiation sterilisation), EN ISO 17665 (steam sterilisation), EN ISO 11607 (sterile packaging).

GSPR 8 — Devices incorporating a medicinal substance​

Where a device incorporates a medicinal substance (drug-device combination under MDR Rule 14):

  • The safety, quality, and usefulness of the incorporated substance must be verified
  • A consultation with EMA or a national medicines authority is required as part of notified body assessment
  • The substance must comply with applicable pharmaceutical requirements

See Devices incorporating a medicinal substance for full detail.

GSPR 9 — Devices with human/animal tissues​

Where a device incorporates non-viable tissues or cells of human or animal origin:

  • Viral inactivation and TSE risk reduction must be demonstrated
  • For animal-derived materials: species, source, and processing must be justified
  • Specific standards apply: EN ISO 22442 series (use of animal tissues in medical devices), Ph. Eur. chapter 5.2.8 (minimising TSE risk)

See Devices with human/animal tissues.

GSPR 10 — CMR substances and endocrine disruptors​

Devices must not incorporate carcinogenic, mutagenic, or reprotoxic (CMR) substances (categories 1A or 1B per Regulation (EC) 1272/2008) or endocrine disrupting substances unless:

  • Their presence is technically unavoidable, and
  • The manufacturer justifies that patient/user risk is acceptable, and
  • No suitable alternatives exist

MDCG 2020-10 provides guidance on this requirement. Specific restrictions apply to phthalates, BPA, and other substances in devices contacting patients.

GSPR 11 — Interaction with the environment​

Devices must be designed to minimise risks from:

  • Electromagnetic interference (both susceptibility and emission)
  • Environmental conditions (temperature, pressure, humidity) affecting performance
  • Compatibility with other devices or equipment used in combination

GSPR 12 — Devices with a measuring function​

Where a device incorporates a measuring function (clinical relevance):

  • Must be designed to provide sufficient accuracy, precision, and stability
  • Measurement uncertainty must be clearly stated in the IFU
  • Calibration and traceability to SI units (or appropriate reference standards) must be established
  • Verification and calibration intervals must be specified

GSPR 13 — Protection against radiation​

Devices that emit radiation (ionising or non-ionising) intended for diagnostic or therapeutic purposes:

  • Must emit only radiation necessary for the intended purpose
  • Exposure must be measurable and controllable
  • Protection from stray radiation for patients, users, and third parties
  • Compliance with applicable radiation protection legislation

For ionising radiation devices: specific requirements on dose display, dose reduction features, and protection modes.

GSPR 14 — Active devices: energy sources​

Devices that depend on an external energy source must:

  • Continue to function safely during power failure where a sudden stop would be dangerous
  • Indicate when power is insufficient to maintain safe operation
  • Be protected against foreseeable interference with power supplies

GSPR 15 & 16 — Mechanical and thermal risks​

Devices must be designed to reduce risk from:

  • Mechanical hazards: fracture, sharp edges, moving parts, vibration, noise
  • Thermal hazards: burns from contact with hot surfaces or inappropriate temperature output
  • Risks must be addressed within the risk management process under EN ISO 14971

GSPR 17 — Devices for self-testing or near-patient testing​

Where devices are intended for use by lay persons (self-test) or near-patient settings:

  • Designed to be as simple as possible to use correctly
  • Instructions must be clear and understandable for the intended user (including those with no medical training)
  • Results must be interpretable by the intended user
  • Risk of incorrect use must be minimised through design (error detection, clear interfaces)
  • Usability studies are required — typically following IEC 62366-1 (Usability engineering)

GSPR 18 — Electromagnetic compatibility (EMC)​

Devices must be designed and manufactured to:

  • Achieve adequate immunity to electromagnetic disturbance
  • Limit electromagnetic emission to not interfere with other equipment or infrastructure
  • Be safe in the electromagnetic environment in which they are intended to operate

Key standard: EN 60601-1-2 (Electromagnetic disturbance requirements for medical electrical equipment).

GSPR 19–22 — Active and implantable devices​

Higher-level requirements for:

  • Protection against risks from connected or networked devices (interoperability)
  • Implantable device specific requirements including battery life, fixation, and degradation
  • Software requirements (covered separately in GSPR 17 for software-as-device)
  • Active implantable device specific requirements for longevity and in-situ function

Documenting Chapter II compliance​

In the technical documentation's GSPR cross-reference table, each applicable Chapter II GSPR must be linked to:

  1. The harmonised standard, CS, or other solution used
  2. The evidence of compliance (test reports, analysis, calculations)
  3. Any deviations from harmonised standards and their justification

Official references​

ReferenceDescription
MDR Annex I, Chapter IIGSPR 6–22 full text
EN ISO 14971:2019Risk management
EN ISO 10993-1:2018Biological evaluation
EN 60601-1:2006+A1:2013Medical electrical equipment
IEC 62366-1:2015+A1:2020Usability engineering
EN 62304:2006+A1:2015Software lifecycle
MDCG 2020-10CMR and endocrine disruptors guidance