The EU IVD Regulation 2017/746 calls for evidence of conformity to the applicable General Safety and Performance Requirements (GSPRs) to be provided in the device technical documentation. Under the IVD Regulation, the 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 requirements to 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. This justification will demonstrate to a reviewer that you have duly considered each and every requirement individually according to your specific device.
The GSPR Breakdown
The GSPRs are separated into three chapters within Annex I:
• Chapter I (GSPRs 1 – 8) examines the General Requirements related to risk management, risk control, and benefit-risk.
• 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.
• 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.
TIP! While the eight GSPRs in Chapter I apply to all devices regardless of device type, the applicability of the requirements listed in Chapters II and III must be examined on a case-by-case basis, depending on the nature of the device in question.
What should you include in your GSPR checklist?
The completed checklist must include:
- 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 appliable 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.
10 steps to successful completion of your checklist
Completion of your GSPR checklist is generally one of the last activities that is carried out during the conformity assessment process. Generation of all other relevant conformity assessment documentation prior to the completion of the GSPR checklist will allow you to precisely identify the location of the evidence within the completed technical documentation, and to ensure that you have indeed achieved conformity with the requirements.
Follow these 10 steps to help you successfully complete your GSPR checklist:
Step 1: Create a template for your checklist, or download our free checklist template here
Step 2: Closely examine each GSPR with your specific device in mind.
Step 3: Indicate whether the GSPR is applicable. Remember that GSPRS 1-8 all apply!
Step 4: Consider what methods you have used to demonstrate conformity.
Depending on the GSPR in question, this could include for example, the development of an approved risk management system, or conducting analytical or clinical performance studies.
Step 5: Reference the solutions that you applied to meet the requirement.
This might include harmonised standards, common specifications, other ISO standards, CLSI guidelines, guidance documents (e.g. MDCG), or even internal standards that have been established within your own organisation.
Step 6: Precisely identify the specific location of the evidence showing that you are conformance with the requirement.
This could include a test report or protocol, an externally issued certificate (such as ISO 13485 certificate), your risk management file, internal standard operating procedures (SOPs), performance evaluation reports, or any other documentation that you consider relevant to the GSPR in question.
Remember to reference the exact sections of these documents that are supporting the requirement!
Step 7: Where possible, provide hyperlinks to the location of the evidence to make it as easy as possible for a reviewer to check and to cross-reference between documents.
Step 8: For any GSPRs that were indicated as being not applicable to your device, ensure that you adequately justify this fact within the checklist, leaving no room for doubt regarding the accuracy of that claim.
Step 9: Include a tab of standards you have referenced throughout your checklist, complete with their relevant revision information where applicable.
Step 10: Record the author and approver information, to include names, job titles, signatures and dates.
What does a completed GSPR Checklist look like?
Well, we have a few examples we can share!
The below excerpts provide an example of how you could present both an applicable and a non-applicable GSPR, along with the level of detail that a reviewer might expect to see on your checklist.
The text shown is intended to be used for illustrative purposes only and should be adapted to accurately align with the documentation and procedures within your own organisation.
Example of an applicable GSPR:
Example of a potentially non-applicable GSPR:
Need support in the compilation of your GSPR checklist?
At Trinzo, we are here to support you by:
- performing a gap analysis of your existing IVDD essential requirements to identify any remediation that must be completed to comply with the GSPRs,
- assisting you in identifying which of the GSPRs are applicable to your device,
- auditing your GSPR checklist in advance of your notified body audit, to identify any potential future findings,
- remediating your risk management files, performance documentation, and labelling material to bring you into compliance with the GSPRs.