General Safety and Performance Requirements under IVDR
Introduction
The GSPRs in Annex I of IVDR 2017/746 set the fundamental safety and performance standards that all in‑vitro diagnostic devices must meet to be placed on the EU market. They replace earlier “essential requirements” for IVDs and apply across all device classes (A to D).For manufacturers and authorised representatives, compliance means linking design, manufacture, performance evaluation, risk management and labelling back to the GSPRs.
Structure Of Annex i General Safety And Performance Requirements – Overview
Annex I is divided into three Chapters:
Chapter I – General requirements (clauses 1 to 8) covering overarching safety, performance and risk‑based obligations.
Chapter II – Requirements regarding performance, design & manufacture (clauses 9‑19) relating to device design, materials, performance characteristics, manufacturing and use conditions.
Chapter III – Requirements regarding the information supplied with the device (clauses 20) covering labelling, instructions for use (IFU), packaging and user information.
This structure helps in organising your technical documentation and in linking each requirement to relevant evidence (risk files, test reports, IFUs, etc).
Chapter I: General Requirements
Device suitability for intended purpose
Devices must be designed and manufactured so that, under normal conditions of use, they are suitable for their intended purpose, are safe and effective, and do not compromise the clinical condition or safety of patients, users or others. (Annex I, 1)
This means the manufacturer must clearly specify the intended purpose and ensure design/validation demonstrate suitability for that purpose.
Risk reduction “as far as possible”
The requirement to reduce risks means reducing them as far as possible without adversely affecting the benefit–risk ratio. (Annex I, 2)
In practice this demands a documented risk‑management process with state‑of‑the‑art measures, and trade‑offs must be justified.
Risk‑management system
Manufacturers are required to establish, implement, document and maintain a comprehensive risk‑management system throughout the device lifecycle. (Annex I, 3)
Risk management must be iterative, updated with production and post‑market data.
Design/manufacture – risk control
Risk control measures must align with established safety principles, considering the current state of the art. Residual risks must be judged acceptable. Users must be informed of residual risks. (Annex I, 4)
Use‑error considerations
Manufacturers must reduce risks related to use error by addressing ergonomic features, the environment of use, user knowledge/training, and the characteristics of intended users (lay, professional, disabled, etc). (Annex I, 5)
This emphasises human‑factors engineering, especially for IVDs intended for near‑patient or self‑testing.
Performance over lifetime
Devices must be designed/manufactured so that characteristics and performance over lifetime (as indicated by manufacturer) remain safe and effective under normal use and maintenance. (Annex I, 6)
This covers durability, maintenance, calibration, etc.
Packaging, storage, transport
Devices must be designed, manufactured and packaged so that their characteristics and performance are not adversely affected during transport and storage (taking into account manufacturer’s instructions). (Annex I, 7). Thus, conditions like temperature/humidity extremes must be assessed.
Benefit–risk judgement
All known and foreseeable risks, and any undesirable effects, must be minimised and be acceptable when weighed against the evaluated potential benefits of the device during normal use. (Annex I, 8)
Manufacturers must document the benefit–risk analysis showing that residual risk is justified by benefit.
Chapter ii: Requirements Regarding Performance, Design & Manufacturers
Performance characteristics (analytical + clinical)
Devices must be designed/manufactured so they are suitable for their intended purpose and achieve the performance stated by the manufacturer, taking into account the state of the art. (Annex I, 9.1)
Analytical performance (e.g., sensitivity, specificity, limits) and clinical performance (e.g., diagnostic sensitivity/specificity, predictive values) must be addressed. (Annex I, 9.1(a/b))
Performance must be maintained during lifetime. (Annex I, 9.2)Where calibrators/control materials are used, metrological traceability must be assured. (Annex I, 9.3)
For self‑testing or near‑patient testing devices, performance must be verified in the relevant environment or by lay persons. (Annex I, 9.4)
Chemical, physical & biological properties
Devices must be designed/manufactured so the requirements of Chapter I are fulfilled. Pay particular attention to incompatibility between materials/substances and specimens, analyte/marker, body fluids, etc. (Annex I, 10.1)
Packaging and manufacturing must minimise risk from contaminants/residues; special attention to CMR (carcinogenic, mutagenic, reproductive toxicity) substances and endocrine disrupting substances. (Annex I, 10.2‑10.4)
Devices must reduce risk of ingress of substances and risks linked to particle release including nanomaterials. (Annex I, 10.5‑10.6)
Infection/microbial contamination
Design, manufacture and packaging must eliminate or reduce as far as possible the risk of infection to users/patients/others. (Annex I, 11.1)
If labelled sterile or specific microbial state, the device must maintain that state through transport/storage until point of use. (Annex I, 11.2‑11.4)
Materials of biological origin
If applicable, this clause requires special attention to devices incorporating materials of human or animal origin, ensuring sourcing, processing, documentation, traceability, and minimised risk of infection/transmission. (Annex I, 12)
Construction & interaction with environment
Devices must be constructed so that they perform safely under the intended conditions of use and in the environment in which they will be used—including compatibility with other devices if applicable. (Annex I, 13)
Measuring functions
For devices with measuring functions, accuracy, calibration, influence of environment, drift, reference intervals must be addressed. (Annex I, 14)
Protection against radiation
If devices emit or are exposed to radiation (ionising or non‑ionising) then design/manufacture must ensure protection of users/patients/others. (Annex I, 15)
Software / electronic programmable systems
If the device contains software, or is software, design lifecycle, validation, security, reliability, updateability must be addressed. (Annex I, 16)
Devices connected to energy source
If a device is connected to or equipped with an energy source (electrical, hydraulic, pneumatic, etc), risk from source must be minimized — include shielding, insulation, safe design. (Annex I, 17)
Protection against mechanical/thermal risks
Devices must be designed/manufactured so mechanical and thermal risks (heat, pressure, vibration, sharp edges, unstable parts) are addressed and minimised. (Annex I, 18)
Self‑testing / near‑patient testing risks
Devices intended for self‑testing or near‑patient testing must be designed so lay persons or use in non‑laboratory environments do not compromise safety or performance; instructions must reflect that environment. (Annex I, 19)
Chapter III: Requirements Regarding The Information Supplied With The Device
General information requirements
Manufacturers must supply information which allows identification of device and manufacturer, and any relevant safety and performance information for users or others. (Annex I, 20.1)
Labelling information
Labels must include information such as device name, manufacturer, intended purpose, CE marking, UDI, warnings/precautions, storage conditions, batch/serial, etc. (Annex I, 20.2)
Packaging of sterile devices
Where devices are supplied sterile or in a particular microbial state, packaging must clearly indicate that state, instructions for maintaining state, and warnings if packaging integrity is compromised. (Annex I, 20.3)
Instructions for use (IFU)
IFUs must include information for safe and proper use of the device: intended purpose, user type, specimen requirements, performance characteristics, contraindications, warnings, storage/handling, interpretation of results, residual risks, disposal, symbols, and more. (Annex I, 20.4)
Mapping GSPR Compliance In Technical Documentation
When preparing your technical documentation (for conformity assessment under IVDR), each GSPR clause must be mapped in a checklist (GSPR matrix) showing: applicability (yes/no), reference to where evidence is located (risk file, test reports, IFU, design verification, etc). This mapping supports demonstration of conformity and audit readiness.
Linking GSPR to risk management (e.g., ISO 14971), performance evaluation (Annex XIII), post‑market performance follow‑up, and labelling is essential.
Key Implementation Tips For IVD Manufacturers
Define and document the intended purpose clearly: user type (lay/professional), environment (lab/home/POC), specimen types, analyte/marker.
Set up or enhance a risk‑management system that covers the entire lifecycle and links to both design & post‑market surveillance.
For analytical and clinical performance, ensure validation/verification covers lay use or near‑patient settings if applicable (GSPR 9.4).
For software/connected devices, ensure lifecycle processes (development, validation, update, cybersecurity) are aligned with GSPR 16.
Ensure labelling and IFU content covers all required elements (GSPR 20), including residual risk disclosures and usage limits.
Establish procedures for transport/storage stress and validate device performance under those conditions (GSPR 7).
Maintain traceability of materials, especially if using biological origin materials (GSPR 12) or materials exhibiting wear/debris (GSPR 10).
Use the GSPR checklist in your QMS, link evidence, cross‑reference to design verification and performance evaluation documentation.
Common Pitfalls And Audit Focus Areas
Treating the GSPRs as a static checklist rather than a life cycle‑oriented system. (As noted in commentary)
Declaring a GSPR clause “not applicable” without justified rationale and evidence.
Lack of documented proof of performance maintenance over lifetime (GSPR 9.2) or real‑world use environment (GSPR 9.4).
Inadequate addressing of use‑error risk, especially for lay/self‑testing devices (GSPR 5 & 19).
Insufficient labelling/IFU details, especially residual risks, limitations, user training, or language suitability.
Overlooking packaging/transport/storage impact on performance (GSPR 7).
In software devices or connected IVDs, insufficient documentation of cybersecurity, updates or algorithm changes (GSPR 16).
Conclusion
The GSPRs in Annex I of IVDR form the foundational safety and performance backbone for IVD devices placed in the EU market. Compliance requires not only meeting individual clauses, but integrating them into your design, manufacture, risk management and post‑market systems. Mapping each clause to evidence, cross‑linking documentation and maintaining ongoing oversight are key to audit‑ready submission.
How Morulaa Can Help With GSPR Compliance
Morulaa ensures your devices meet the General Safety and Performance Requirements (GSPR) in IVDR. We help you understand and implement each requirement throughout the product lifecycle. Morulaa assists in creating technical documentation and GSPR matrices to map each requirement to your design, manufacturing, and risk management processes, ensuring audit-readiness.