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GSPR MADE EASY: YOUR NO-STRESS GUIDE TO EU MDR SAFETY RULES
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The EU MDR requires all medical device manufacturers to show that their devices are safe, perform as intended, and remain reliable throughout their lifecycle. This is done by meeting the General Safety and Performance Requirements (GSPR) listed in Annex I of the Regulation. Article 10(4) makes this obligation mandatory manufacturers must comply with every applicable requirement in Annex I and provide evidence for it. In simple terms, GSPR is the foundation that proves a device is safe for patients and users. Annex I is divided into three main parts: overall safety principles (Chapter I), detailed design and manufacturing requirements (Chapter II), and requirements for information provided with the device, such as labels and IFUs (Chapter III). These cover everything from biological safety, chemical properties, software and electrical safety, sterility, usability, and measuring functions, to warnings and instructions for users. Manufacturers must review each requirement, decide whether it applies to their device, justify if it does not, and link evidence such as testing, risk management and validation reports if it does. To demonstrate conformity, manufacturers usually prepare a GSPR checklist or matrix. This document maps each GSPR clause to supporting evidence within the Technical Documentation. It ensures nothing is missed and helps Notified Bodies quickly verify compliance. Strong risk management, proper design controls, up-to-date standards, correct labelling, and a feedback loop from post-market surveillance all play important roles in meeting GSPR obligations. For beginners, the practical approach is simple: identify which GSPRs apply to your device, gather or generate evidence for each one, document clear justifications for non-applicable requirements, and maintain this matrix throughout the device lifecycle. Keeping the GSPR matrix updated especially when the device is modified ensures continued compliance and smooth Notified Body review. |
INTRODUCTION
For medical device manufacturers seeking market entry into the European Union, compliance with the regulatory framework established by the EU MDR regulation is essential. One of the cornerstone obligations under the Regulation is the fulfilment of the General Safety and Performance Requirements (GSPR) as laid down in Annex I. These requirements, together with the manufacturer’s obligations under Article 10(4), set the baseline for demonstrating that a device is safe, performs as intended, and maintains a high level of protection of health and safety throughout its lifecycle. In this blog we will explore what GSPR means in practice, how it links to Article 10(4) and Annex I, and practical steps manufacturers should implement to demonstrate conformity.
ARTICLE 10(4) AND THE MANUFACTURER’S OBLIGATION
What Article 10(4) Says
Article 10 of the EU MDR sets out the obligations of manufacturers. Sub‑paragraph (4) states that:
“Manufacturers shall ensure that devices comply with the general safety and performance requirements set out in Annex I.”
Thus, the Regulation makes explicit that complying with Annex I is a mandatory element of placing or making available a device on the market.
Implications for Manufacturers
This means that compliance with GSPR is not optional; it is a regulatory requirement, not simply a best practice. The manufacturer must:
- identify applicable requirements in Annex I and determine whether each is applicable or not;
- provide objective evidence that the device fulfils those that are applicable;
- justify why any given requirement is not applicable (if that is the case).
In short, one must embed the GSPR within the technical documentation and conformity assessment route.
Integration with Technical Documentation
The manufacturer must integrate this requirement into the Technical Documentation (per Annex II Section 4) and ensure traceability from each GSPR requirement to evidence (e.g., design output, verification/validation reports, risk management records).
By doing so, conformity to Article 10(4) is demonstrated within the full regulatory submission or Notified Body audit context.
STRUCTURE AND CONTENT OF ANNEX I (GSPR)
The GSPR set out in Annex I of the EU MDR are broadly divided into three chapters:
- Chapter I – General Requirements (Sections 1 to 9)
- Chapter II – Requirements regarding design and manufacture (Sections 10 to 22)
- Chapter III – Requirements regarding the information supplied with the device (Sections 23)
Chapter I – General Requirements
These establish the overarching safety principle: devices must be safe and effective, and must not compromise the clinical condition or safety of patients/users where risks are balanced against intended benefits. For example:
- Section 1: the device shall achieve its intended performance under normal conditions of use.
- Section 2: risks shall be eliminated or reduced as far as possible without adversely affecting the benefit‑risk ratio.
These requirements emphasise that risk management, device lifecycle control, and state‑of‑the‑art considerations are central.
Chapter II – Requirements regarding design and manufacture
This chapter is more specific and covers technical aspects: chemical, physical, biological properties (Section 10), infection/microbial contamination (Section 11), devices incorporating medicinal substances (Section 12), materials of biological origin (Section 13), construction and interaction with environment (Section 14), devices with measuring/diagnostic function (Section 15), protection against radiation (Section 16), electronic systems (Section 17) and further sections covering active implantable devices, mechanical/thermal risks, reuse, etc.
Chapter III – Information Supplied with the Device
This final chapter deals with the labelling, instructions for use (IFU), packaging and user information. For example, Section 23 details how information must accompany the device, be appropriate for the user, be legible, and include all residual risks. Manufacturers must therefore ensure their labelling and IFU reflect device characteristics, user training level, and residual risks.
DEMONSTRATING CONFORMITY: KEY ELEMENTS FOR MANUFACTURERS
To meet the GSPR requirement and satisfy Article 10(4), manufacturers should consider the following key areas:
1. Gap Analysis and GSPR Checklist
Start with a gap analysis: map your existing documentation (for example under the old MDD Essential Requirements) against the GSPR list in Annex I. Identify missing evidence, updated standards or design changes. Industry sources highlight that manufacturers should adopt a structured GSPR checklist, referencing harmonised standards, risk management outputs, verification/validation results, and traceability to each applicable requirement.
A robust checklist helps to maintain transparency and readiness for Notified Body review.
2. Technical Documentation Traceability (GSPR Matrix)
Develop a GSPR matrix: this links each clause in Annex I to the supporting evidence for your device (or justifies non‑applicability) and identifies the document reference and location within your Technical File.
Such traceability demonstrates to auditors/regulators that you have considered every requirement systematically, and you can justify any exclusions.
3. Risk Management and State‑of‑the‑Art Considerations
Risk management is central to fulfilling GSPR. For example, Chapter I, Section 4 requires manufacturers to implement and maintain a risk management system addressing known and foreseeable hazards, and to evaluate information from post‑market surveillance.
Also, “taking into account the generally acknowledged state of the art” is a recurring phrase in Annex I – so manufacturers must stay abreast of updated standards, guidance, scientific literature, and safety trends.
4. Design and Manufacture Controls
For the design/manufacture chapters (Chapter II), manufacturers must show how design controls, material selection, biological safety (e.g., ISO 10993), usability, cleaning/sterilisation, software cybersecurity and other factors were considered. For example, Section 10 addresses chemical/biological safety, and Section 17 covers electronic programmable systems. Ensuring that testing, verification, validation and supplier controls are documented is essential.
5. Labelling, IFU, Packaging and User Information
Under Chapter III, you must ensure your label and IFU are appropriate, legible, matched to the user’s skill level, and include all relevant information on residual risk, contraindications, warnings, symbols etc. For example Section 23.1(a) emphasises that instructions must be written in terms readily understood by the intended user.
Manufacturers should also ensure language requirements per Member State are addressed, though that is more broadly under Article 10(10) and other obligations.
6. Post‑Market Surveillance and PMS Integration
Though PMS is addressed elsewhere in the Regulation, Annex I implicitly requires that the device’s characteristics and performance “shall not be adversely affected during the lifetime of the device as indicated by the manufacturer…” (e.g., Section 6).
This means your PMS plan, vigilance system, periodic safety update reports (PSURs) and modification control process must feed back into your GSPR compliance and technical documentation.
PRACTICAL TIPS FOR IMPLEMENTATION BY MANUFACTURERS
- Maintain a live GSPR checklist/matrix: Reference harmonised standards, common specifications, test reports, risk management records and clinical evaluation evidence.
- Justify non‑applicability: If a requirement does not apply (e.g., device has no measuring function so Section 15 irrelevant), document clearly why and retain this justification.
- Link design changes to GSPR reviews: Whenever you modify the device, revisit the GSPR matrix to assess if new requirements now apply (e.g., incorporating software introduces Section 17).
- Use harmonised standards where available: Conformance to a harmonised standard creates a presumption of conformity to relevant GSPR – though you still must show device‑specific compliance.
- Involve multidisciplinary teams: Regulatory, quality assurance, design engineering, clinical/biocompatibility specialists should collaborate to address the broad technical and safety aspects of Annex I.
- Regularly update documentation: The state of the art evolves; your risk management file, PMS inputs, design control records and technical documentation must be reviewed periodically to ensure ongoing GSPR conformity.
- Prepare for Notified Body review: The GSPR matrix is often one of the first items scrutinised during conformity assessment. Being able to trace every GSPR requirement to documentation will facilitate audit readiness.
CONCLUSION
Compliance with the GSPR set out in Annex I of the EU MDR, and meeting the manufacturer obligation under Article 10(4), is a foundational step for any medical device manufacturer wishing to place devices on the EU market. By understanding the structure of the GSPR, integrating them into your technical documentation, and implementing a robust and traceable approach to design, manufacture, user information and post‑market surveillance, you will enhance your regulatory readiness and demonstrate your device’s safety and performance. Following a disciplined process from gap analysis, through checklist and matrix development, to evidence gathering and ongoing review positions your organisation for success, supports conformity assessment, and mitigates the risks of non‑compliance. In a highly regulated environment, the path to CE‑marking and market access is strengthened by strong GSPR governance.
HOW MORULAA CAN HELP
Morulaa HealthTech helps medical device manufacturers ensure full compliance with the General Safety and Performance Requirements (GSPR) under EU MDR 2017/745. We assist in preparing detailed GSPR checklists, performing gap analyses, and mapping technical documentation to Annex I requirements. Our team supports the creation of audit-ready GSPR matrices, aligned with Article 10(4), and integrates evidence from risk management, clinical evaluation, and harmonised standards. We also offer guidance on labelling, IFUs, and PMS feedback integration—ensuring a smooth path to CE marking and regulatory approval.