Under the IVD Regulation, the General Safety and Performance Requirements (GSPRs) of Annex I are more demanding that their IVD Directive counterparts, the Essential Requirements. Where the IVD Directive included 13 Essential Requirements, the IVD Regulation has 20 GSPRs that must be considered. 

IVD manufacturers must demonstrate conformity with the GSPRs, including the use of justification, validation, and verification of the solutions used to meet the applicable requirements. For those requirements which are considered to not be applicable, a justification of this fact must be provided.

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What does a completed IVDR GSPR Checklist include? 

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• The general safety and performance requirements that apply to the device and an explanation as to why others to not apply;

• The method or methods use to demonstrate conformity with each applicable requirement;

• The standards, common specifications, or other solutions applied to meet the requirement;

• The precise identity of the controlled documents offering evidence of conformity with each standard, common specification or other method applied to demonstrate conformity with the general safety and performance requirements. The information referred to under this point shall incorporate a cross-reference to the location of such evidence with the full technical documentation.

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What are the IVDR GSPR Requirements? 

 

The GSPRs are separated into three chapters:

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• Chapter I (GSPRs 1 – 8) examines the General Requirements related to risk management, risk control, and benefit-risk. The eight GSPRs in this chapter apply to all devices. 

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• Chapter II (GSPRs 9 – 19) deals with Requirements Regarding Performance, Design, and Manufacture. This chapter is broken down into the following subsections:

o    Performance characteristics
o    Chemical, physical and biological properties
o    Infection and microbial contamination
o    Devices incorporating materials of biological origin
o    Construction of devices and interaction with their environment
o    Devices with a measuring function
o    Protection against radiation
o    Electronic programmable systems
o    Devices connected to or equipped with an energy source
o    Protection against mechanical and thermal risks
o    Protection against the risks posed by devices intended for self-testing or near-patient testing.

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• Chapter III (GSPR 20) focuses on Requirements Regarding Information Supplied With The Device, specially the following aspects:

o    Label and instructions for use
o    General requirements regarding the information supplied by the manufacturer
o    Information on the label
o    Information on the packaging which maintains the sterile condition of a device
o    Information in the instructions for use.

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The applicability of the requirements listed in Chapters II and III should be examined on a case-by-case basis, depending on the nature of the device in question. 

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How to use this GSPR Checklist 

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• Download this easy-to-use GSPR template as a Microsoft Word document straight to your PC

• Sample text has been included in blue italics throughout the checklist to aid as guidance for your own data 

• Easily identify the standards or other solutions that are relevant to your device, and to each GSPR

• Helpful suggestions are included on the available methods that could be used to demonstrate conformity to each GSPR

• It's fully free - no catch! 

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