General Safety and Performance Requirements (GSPR)

Several new requirements and topics have been introduced in medical device regulations, emphasizing the importance of specific minimum essential product characteristics; in this context GSPRs (General safety and performance requirements), play a fundamental role. . This concept is not unique to the EU MDR 2017/745 but is also present in other global medical device regulations, such as those in Canada and Australia, where they are referred to as “essential principles.”

Within the EU MDR 2017/745, these minimum essential product characteristics are outlined in 23 General Safety and Performance Requirements (GSPR) categorized into three main chapters as specified in Annex I:

Chapter 1 – General requirements (GSPR 1 to 9) Chapter 2 – Design and Manufacturing requirements (GSPR 10 to 22) Chapter 3 – Labeling and Instructions for Use (GSPR 23)

In this article, our main focus will be on discussing the General Requirements (GSPR 1 to 9), which encompass safety and performance requirements. The remaining requirements will be addressed in separate posts, allowing for a comprehensive exploration of each topic.

By examining and understanding the General Requirements outlined in the EU MDR 2017/745, medical device manufacturers can gain valuable insights into the fundamental criteria that must be met to ensure the safety and performance of their products. These requirements serve as a framework for evaluating the compliance of medical devices with established standards and guidelines, promoting the delivery of safe and effective healthcare solutions to patients.

Through in-depth analysis and discussion, we will delve into each General Requirement, providing valuable guidance and insights to assist manufacturers in navigating the complex landscape of regulatory compliance. Our aim is to foster a comprehensive understanding of these requirements, empowering manufacturers to develop and deliver high-quality medical devices that meet the stringent safety and performance standards set forth by the EU MDR.

In subsequent posts, we will explore the Design and Manufacturing requirements, as well as the Labeling and Instructions for Use requirements, providing a holistic examination of the EU MDR 2017/745 and its impact on medical device manufacturers. By breaking down these requirements into digestible segments, we aim to provide clarity and practical guidance to ensure compliance and facilitate successful market access for medical devices within the European Union.

Compliance to GSPR is an essential steps in the framework of design and development process and it should be addressed rather early in the design control process.

Section 1 of GSPR: General Requirements

Let’s start to have a look to the General Safety and Performance Requirements listed in the EU MDR 2017/745.

GSRP 1: Performance and Safety

The initial safety and performance requirement outlined in the EU MDR 2017/745 emphasizes the critical importance of designing medical devices in a manner that ensures the absence of any potential safety hazards or risks to patients, users, and individuals in close proximity. This requirement revolves around the concept of creating devices that are both suitable and safe for their intended purpose.

To meet this requirement, manufacturers must carefully evaluate and address any potential safety concerns associated with their devices. This entails conducting thorough risk assessments and implementing appropriate measures to mitigate risks throughout the device’s lifecycle. The ultimate goal is to develop a device that not only fulfills its intended purpose effectively but also maintains an acceptable level of risk in relation to the benefits it offers to patients.

Regardless of the specific intended purpose of the device, the safety aspect remains paramount. The risk-benefit analysis should always weigh in favor of patient safety, ensuring that the potential risks associated with the device are justifiable and outweighed by the positive impact on patient health and well-being.

GSRP 2: Reduction of Risks

The second Safety and Performance requirement outlined in the EU MDR 2017/745 emphasizes the need to minimize risks associated with medical devices while maintaining an acceptable balance between risk and benefit. Manufacturers are expected to diligently work towards reducing risks to the greatest extent possible without compromising the overall benefit-risk ratio.

In certain instances, it may be possible to further reduce risks through modifications to the device’s design. However, it is crucial to consider the potential impact of these changes on the device’s performance and benefits. While reducing risks is essential, it should not come at the expense of compromising the device’s effectiveness or its ability to provide significant benefits to patients.

Manufacturers must conduct comprehensive risk assessments and carefully evaluate any proposed design changes to determine their impact on both risk reduction and device performance. This requires striking a delicate balance between mitigating risks and preserving the device’s intended purpose and functionality. It is imperative to avoid unnecessary alterations that could negatively affect the overall risk-benefit ratio.

Finding the optimal equilibrium between risk reduction and device performance requires a thorough understanding of the device’s intended use, its inherent risks, and the potential benefits it offers to patients. This involves meticulous evaluation and consideration of various factors such as clinical evidence, user feedback, and post-market surveillance data.

GSRP 3: Risk Management System

The Safety and Performance Requirement highlighted in the EU MDR 2017/745 emphasizes the crucial role of risk management activities throughout the entire lifecycle of a medical device. As indicated by the title itself, this requirement underscores the significance of ongoing risk management processes in ensuring the safety and effectiveness of the device.

According to the regulation, the risk management process, following the principles outlined in ISO 14971, should be conducted as a continuous and comprehensive endeavor. It mandates specific activities that must be undertaken as part of the risk management framework. These activities include:

1. Development of a risk management plan tailored to each type of device being manufactured.
2. Identification and analysis of all known and foreseeable hazards associated with the device.
3. Estimation and evaluation of the risks associated with the identified hazards.
4. Implementation of appropriate measures to eliminate or control the identified risks.
5. Regular evaluation and review of production and post-production information to ensure that risk estimations remain up to date.
6. Re-evaluation of risk control measures whenever necessary, based on the collection and analysis of production and post-production information.

These steps may appear familiar to organizations that have already established a robust risk management process aligned with the requirements of ISO 14971 and ISO 24971. Compliance with these standards ensures that the risk management activities conducted by the organization are comprehensive, systematic, and in line with industry best practices.

By adhering to this Safety and Performance Requirement, manufacturers demonstrate their commitment to proactive risk management and the continuous improvement of their devices’ safety profiles. It provides a structured framework for identifying, assessing, and mitigating risks associated with medical devices, ultimately enhancing patient safety and supporting positive health outcomes.

Implementing an effective risk management process not only ensures compliance with regulatory requirements but also instills confidence in healthcare professionals, regulatory authorities, and patients. It demonstrates the manufacturer’s dedication to maintaining the highest standards of safety and performance throughout the lifecycle of their medical devices.

Furthermore, integrating risk management activities into the overall quality management system allows for a more comprehensive approach to device development, manufacturing, and post-market surveillance. It promotes a proactive mindset, encouraging early identification and mitigation of potential risks, thus minimizing the likelihood of adverse events and maximizing the benefits delivered to patients.

GSPR 4: Risk control measures and residual risks

The Safety and Performance Requirement being discussed here maintains a strong connection to the risk management process. Its focus lies on the evaluation and acceptability judgment of the overall residual risk and the risks associated with each identified hazard.

Within the framework of this requirement, the MDR places an additional obligation on manufacturers, as stated in SPR 4. According to this provision, manufacturers are required to inform users about any residual risks associated with their devices. Although the interpretation of this statement may not be crystal clear, it can be understood as the need to include all residual risks, including foreseeable adverse events and side effects identified through the rigorous risk management process, in the Information for Users.

By including this information, manufacturers aim to provide users with a comprehensive understanding of the potential risks associated with the use of the medical device. This transparency fosters informed decision-making and promotes the safe and effective utilization of the device. Users, such as healthcare professionals and patients, should have access to detailed information about potential risks, enabling them to make well-informed choices regarding device usage and potential mitigation strategies.

It is important for manufacturers to integrate this requirement into their risk management activities and ensure that all relevant residual risks are effectively identified, assessed, and communicated. This can be achieved by diligently documenting and reporting residual risks in the Information for Users, taking into consideration any adverse events or side effects that may arise during device use.

By providing comprehensive and accurate information on residual risks, manufacturers demonstrate their commitment to patient safety and their responsibility to effectively manage and communicate potential risks associated with their devices. This requirement aligns with the overarching goal of the MDR, which is to enhance patient safety and improve overall health outcomes.

GSPR 5: Risks related to use

The text of the fifth Safety and Performance Requirement can be summarized as follows:

When it comes to mitigating risks associated with use errors, the manufacturer is obligated to:

(a) Minimize ergonomic risks associated with the device’s design and the intended usage environment (design for patient safety).

(b) Take into account the technical knowledge, experience, education, training, and usage environment of the intended users, as well as their medical and physical conditions (design for various user groups, such as laypersons, professionals, disabled individuals, and others).

This requirement primarily focuses on a specific category of risks, namely those arising from use errors. It is closely tied to the usability process and aligns with the principles outlined in ISO 62366, which addresses usability engineering for medical devices. The evaluation of usability or human factors is intricately connected to the risk management process. As such, risks associated with user interactions must be meticulously identified, assessed, and mitigated to the greatest extent possible.

Manufacturers are responsible for ensuring that their devices are designed in a way that minimizes the potential for use errors. This involves considering human factors and ergonomics to optimize device usability and user safety. By analyzing and understanding the intended users’ characteristics, skills, knowledge, and the environments in which the device will be used, manufacturers can tailor the design to enhance user performance and reduce the likelihood of errors.

To meet this requirement, a comprehensive usability evaluation should be conducted as part of the device development process. This evaluation should encompass activities such as user research, task analysis, user interface design, and usability testing. By integrating usability engineering into the overall risk management process, manufacturers can effectively identify and address potential use-related risks, thereby enhancing the overall safety and performance of the device.

The usability evaluation should adhere to the principles outlined in ISO 62366, which provides guidance on the application of usability engineering to medical devices. This standard emphasizes the iterative nature of the usability process, encouraging manufacturers to continually gather user feedback, evaluate usability issues, and implement necessary design improvements.

GSPR 6: Device lifetime

The Safety and Performance Requirement emphasizes the importance of maintaining the characteristics and performance of the device throughout its entire lifecycle. Not only should the device operate effectively under normal conditions, but it should also uphold safety standards in the face of reasonably foreseeable maintenance or storage errors, as well as abnormal (stress) conditions.

This requirement recognizes that devices may undergo various maintenance procedures, such as repairs, servicing, or storage, during their lifespan. It is crucial to ensure that these activities do not compromise the device’s safety or performance. The manufacturer must take appropriate measures to minimize the risks associated with such situations.

In practical terms, this means that the device should be designed and constructed in a way that safeguards its integrity and functionality. Adequate instructions and precautions should be provided to users and maintenance personnel, guiding them on the proper handling, storage, and maintenance procedures to minimize the likelihood of errors that could jeopardize safety.

Furthermore, the requirement acknowledges the existence of abnormal or stress conditions that may occur during the device’s use. These conditions might subject the device to higher levels of stress, such as extreme temperatures, pressure, or environmental factors. The manufacturer must ensure that the device maintains its safety and performance characteristics even under such challenging circumstances.

To meet this requirement, manufacturers should consider the potential risks and challenges associated with maintenance and storage activities, as well as abnormal conditions that the device might encounter during its lifetime. Risk assessment and risk management processes should be applied to identify, evaluate, and mitigate any potential hazards or adverse effects resulting from these situations.

GSPR 7: Packaging, transport, storage

Here below is what it is mentioned for the specific Safety and Performance Requirement:

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

Basically, it is essential that manufacturing process and packaging are able to protect the device characteristics during transportation and storage.

GSPR 8: Risk-benefit ratio

This particular point highlights the crucial connection between the risk management process and compliance with ISO 14971. According to the MDR requirements, all identified risks must be minimized to the greatest extent possible, including risks that were initially considered acceptable.

The principle of risk minimization emphasizes the importance of continuously striving to reduce risks associated with a medical device. Even if a risk is initially deemed acceptable, manufacturers are expected to make ongoing efforts to minimize it further. This approach reflects the commitment to enhancing the safety and performance of medical devices throughout their lifecycle.

To determine whether a risk is acceptable, a comprehensive risk-benefit analysis is conducted. This analysis weighs the evaluated risks against the anticipated benefits to the patient and/or user resulting from the device’s performance under normal conditions of use. The aim is to strike a balance where the benefits outweigh the risks, ensuring that the device provides meaningful advantages to its intended users.

Throughout our discussions, we have delved into the intricate details of conducting a thorough risk-benefit analysis and how it should be documented. The analysis requires a comprehensive assessment of the identified risks, their severity, and the likelihood of their occurrence. Simultaneously, it involves a careful evaluation of the potential benefits that the device offers, including improvements in patient outcomes, quality of life, or treatment efficacy.

The documentation of the risk-benefit analysis is of utmost importance. It should clearly outline the methodology employed, the data sources utilized, and the criteria used to determine the acceptability of risks. This documentation serves as a critical reference point for regulatory authorities, notified bodies, and other stakeholders involved in evaluating the device’s compliance with applicable regulations.

GSPR 9 : Devices without a medical purpose

Annex VXI of the EU MDR 2017/745 provides a specific list of a particular type of devices named “Devices without a Medical Purpose”.

The MDR clarifies that these devices shall be compliant with GSPR from 1 to 8; moreover it is clearly mentioned that the devices ‘shall not present any risk’ or ‘no more than the maximum acceptable risks’ consistent with a high level of protection for safety and health.

Devices without an intended medical purpose will need to demonstrate compliance with CSs which will address, at the very least, the application of risk management and, where necessary, clinical evaluation regarding safety.

Compliance Checklist for Technical Documentation

In order to facilitate the control of the compliance of the technical documentation before submission of the dossier to the notified body, 4EasyReg has prepared a compliance checklist with a detailed list of all the requirements for technical documentation according to MDR 2017/745.

This Technical Documentation Checklist will be an essential tool to simplify the assessment of the conformity of your technical dossier. This 15-pages checklist is provided as a word file, thus fully editable to make it suitable according to the type of product your organization is bringing to the market.

Conclusions

In conclusion, we went through the first group of General Safety and Performance Requirements for the EU MDR 2017/745. It is worth to highlight once again the importance of the GSPR for compliance to the MDR requirements; the demonstration of GSPR compliance is a key point for the CE marking process and for the technical dossier of any medical device ready to enter in the European Market.

4EasyReg GSPR Checklist

4EasyReg has made available a GSPR checklist that will help you to ensure compliance of your devices and related documentation with the safety and performance requirements for the EU MDR 2017/745. This is a 50 pages word document, fully editable and customazible according to your need. The first page of the document provides some general instructions on how to use the checklist and how to align it based on the type of medical device under assessment.

Similarly, the analogue GSPR checklist for IVDR 2017/746 has also been made available. The structure is the same, it is a word document of around 80 pages with containing suggestions on the ISO standards and internal documentation to reference on the checklist in order to demonstrate compliance to each of 20 GSPRs present in the Annex I of the EU In-Vitro Diagnostic Medical Device Regulation 2017/746.

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