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.
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:
In both MDR and IVDR General Safety and Performance Requirements are divided into three chapters:
Putting that in layman's terms, MDR and IVDR contain the following general requirements:
Chapter 2 of Annex I of MDR/IVDR provides GSPR related to development and production, specifically covering the following:
Within each of these positions, the GSPR defines key aspects that should be considered by designers and manufacturers.
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:
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.
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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.
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).
Need EC REP or PRRC for the EU?
Contact us right now:
+49 176 67510274
info@mdrc-consulting.com
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:
In both MDR and IVDR General Safety and Performance Requirements are divided into three chapters:
Putting that in layman's terms, MDR and IVDR contain the following general requirements:
Chapter 2 of Annex I of MDR/IVDR provides GSPR related to development and production, specifically covering the following:
Within each of these positions, the GSPR defines key aspects that should be considered by designers and manufacturers.
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:
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.
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