General Safety and Performance Requirements (GSPRs) checklist
What are the general safety and performance requirements?
Compliance with the general safety and performance requirements is one of the most basic requirements for placing a medical device on the European market. The requirements are a set of product characteristics that European authorities consider essential to ensure that any new device is safe and works as intended throughout its lifetime.
The GSPR contains twenty-three requirements according to Medical Device Regulation (MDR) and twenty requirements according to In-Vitro Diagnostics Regulation (IVDR). Manufacturers wishing to CE mark their equipment must meet these requirements and should be able to demonstrate that they have complied with the GSPR.
Chapter I - GENERAL REQUIREMENTS
The first chapter contains general requirements that may apply to all medical devices.
- Clinical safety
- Device performance
- Risk management evaluation
- Benefit-risk evaluation
- Risk reduction and control
The performance of the medical device should prove how well it can perform. The performance of the device should not be affected by transport and storage. Manufacturers will have to provide documented evidence that this is compliant.
The risk evaluation involves:
- A risk management plan
- Identifying and analysing the known and foreseeable risks
- Estimate and evaluate the risks associated with the device
- Evaluate the impact of information from the production phase and post-market surveillance system on hazards
- Evaluate the frequency of occurrence and estimate the associated risks
Manufacturers will also have to compare the benefits of using this device to its risks. Benefit-risk evaluation is based on:
- The impact analysis from risk evaluation
- Evaluate the overall risk
- Benefit-risk ratio, and risk acceptability
Chapter II - REQUIREMENTS REGARDING DESIGN AND MANUFACTURE
This chapter focuses on the chemical, physical and biological properties
The device should be designed and manufactured to ensure the characteristics and performance requirements referred to in Chapter I are fulfilled, but special attention should be paid to materials and substances used regarding
- material properties
- biophysical/modelling research
- mechanical properties
- surface properties
Chapter III - INFORMATION SUPPLIED WITH THE DEVICE
This chapter focuses on the key information supplied by the manufacturer along with the device. The information should be available on the label, instructions for use, and on the packaging that maintains a device's sterile condition.
For the end user's safety and protection, a manufacturer has a legal obligation to run a series of GSPR checks regularly.
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