GSPR: General Safety and Performance Requirements for medical devices in the EU

GSPR or General Safety and Performance Requirements is a concept specific to European medical device legislation, one of the central concepts of European Medical Device (MDR) and In Vitro Medical Device (IVDR) Regulations. As the name suggests, GSPR is a list of requirements regarding the safety and efficacy of medical devices sold in Europe.

If we turn to the essence of these requirements, it becomes clear that GSPR is the pivotal element of the European regulations MDR 2017/745 and IVDR 2017/746. In other words, the ultimate goal of MDR and IVDR is to make sure that every medical device on the EU market is GSPR compliant. And, in fact, all actions taken by a manufacturer to achieve MDR (IVDR) compliance to have the right to affix the CE-marking, are ultimately aimed at achieving GSPR compliance. General Safety and Performance Requirements are set forth in Annex I to the MDR and Annex I to the IVDR.

GSPR and Essential requirements

The concept of General Safety and Performance Requirements appeared in the European regulatory system along with the entry into force of MDR 2017/745 and IVDR 2017/746. Prior to this, the term Essential requirements was used in Europe, as introduced in Directives MDD 93/42 (medical devices), IVDD 98/79 (in vitro diagnostic devices) and AIMDD 90/385 (active implantable medical devices).

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The Essential requirements of the MDD/IVDD were set out in two chapters of Annex I to these directives and included 13 items. At the same time, GSPR are presented in three chapters of Appendix 1 of the MDR/IVDR and include 23 items. Thus, with the transition to the new legislation, the approach to the requirements for the effectiveness and safety of medical devices has not fundamentally changed, but the scope of the requirements has increased significantly, since the GSPR covers many aspects that were not taken into account in the Essential requirements. In particular, the following aspects were added:

• Requirements for devices containing medicinal products
• Special requirements for products containing tissues of human or animal origin
• Disposal requirements
• Information security aspects
• Requirements for devices intended for use by non-professionals (self-use)
• General requirements for labeling.

GSPR structure

In both MDR and IVDR General Safety and Performance Requirements are divided into three chapters:

Chapter 1 - General Requirements

Putting that in layman's terms, MDR and IVDR contain the following general requirements:

• Products must work in accordance with their design and intended functionality;
• They must not endanger the health or safety of the patient, user or any other person;
• The risks associated with a medical device should be reduced to the maximum extent possible, but not so much that they adversely affect the benefit-risk balance;
• Manufacturers must maintain a risk management system that continues to be updated throughout the product lifecycle;
• Manufacturers and product designers must provide all necessary measures to protect patients and users in cases where risks cannot be completely eliminated;
• Manufacturers should provide patients and users with information about any potential risks. This information should be clear, easy to understand and take into account the level of technical knowledge of users;
• Products must withstand the stresses of normal use throughout their life cycle;
• Products must be designed, manufactured and packaged in such a way as to protect them from damage during transport and storage;
• Designers and manufacturers must make every effort to minimize the negative consequences of using the product. They must also ensure that the potential risks are acceptable compared to the potential benefits of the product to users.

Chapter 2 - Requirements regarding design and manufacture

Chapter 2 of Annex I of MDR/IVDR provides GSPR related to development and production, specifically covering the following:

• Chemical, physical and biological properties
• Possibility of microbial contamination
• Use of substances that are considered drugs
• Use of biological materials
• Interaction with the environment
• Ability to diagnose or measure
• Radioactive properties
• Electronic programming systems
• Active products and products connected to other devices
• Active implantable devices
• Ability to withstand mechanical and thermal risks
• Ability to safely transfer energy or substances to a user or patient
• The possibility of using the product by non-professionals.

Within each of these positions, the GSPR defines key aspects that should be considered by designers and manufacturers.

Chapter 3 - Requirements regarding the information supplied with the device

The last chapter of Annex I deals with the information that the manufacturer must provide the user with the product. The general provisions of this chapter state that each medical device must be accompanied by the information necessary to identify the device and its manufacturer, as well as any safety and performance information relevant to the user. Chapter 3 discusses the information that must be provided:

• On the product label
• In the user manual
• On the packaging of the device, intended to maintain its sterile condition.

Conclusion

GSPR are requirements that every manufacturer of medical devices selling their products in the European Union must comply with, regardless of the type and class of products. These requirements are aimed at ensuring the safety and efficacy of medical devices. Moreover, acceptable safety and efficacy must be ensured throughout the entire life cycle of a medical device. In this connection, a systematic risk management process is needed, which must be constantly updated both before and after the product is placed on the market. The technical documentation of the product must demonstrate compliance with the GSPR and be organized in such a way as to clearly demonstrate this compliance.