The Medical Devices Cluster (MDC) has released a draft update to GN-14: Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices. The consultation is open to industries/ stakeholders from 2 to 30 May 2023. The consultation will result in a new GN-14 (revision 3) as an update of the current GN-14 (revision 2) published in June 2018. The finalized guideline is planned to be published on June 2023
The key update includes clarification notes on the classification of control materials and software, also clarifications to the risk classification rules 1-5. The overview of the updates is as follows:
- ● DEFINITIONS – Addition of the Standalone Software definition:
Standalone software (also known as SAMD in IMDRF technical documents) is a software and/or mobile application that is intended to function by itself and are not intended for use to control or affect the operation of other hardware medical devices.
- ● CHAPTER 4 The Determination of Device Risk Class by the Product Owner using the Rules-based System – Addition of the following points:
- - Control materials with qualitative and quantitative assigned values intended for one specific or multiple analytes should be placed in the same class as the IVD reagent(s);
- - Embedded software should have the same class as the IVD medical device itself;
- - Standalone software should be classified on its own by using the classification rules in this document.
- ● CHAPTER 5 Classification Rules – Updates regarding the classification rules:
RULE 1 (Class D Classification)
- Devices intended to be used to detect the presence of, or exposure to, a transmissible agent in blood, blood components, blood derivatives, cells, tissues or organs or any of their derivatives in order to assess their suitability for transfusion or transplantation, or cell administration.
- Devices intended to be used to detect the presence of, or exposure to, a transmissible agent that causes a life-threatening, often incurable disease with a high or suspected high risk of propagation.
- RULE 2
IVD medical devices intended to be used for blood grouping, or tissue typing to ensure the immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation, or cell administration, are classified as Class C, except when intended to determine the presence of the antigen or antibody for any of the following markers:
(the list of markers is not updated)
RULE 3 (Class C Classification)
● Update on point c):
in detecting the presence of an infectious agent where there is a significant risk that an erroneous result would cause death or severe disability to the individual, fetus, or embryo being tested or to the individual’s offspring (e.g. diagnostic assay for CMV, Chlamydia pneumoniae, Methycilin Resistant Staphylococcus aureus).
● Update on point e):
in determining infective disease status or immune status, and where there is a risk that an erroneous result will lead to a patient management decision resulting in an imminent life-threatening situation or severe disability for the patient or for the patient’s offspring (e.g. Enteroviruses, CMV, and HSV in transplant patients).
● Update on point f):
in screening for selection of patients for selective therapy and management, or in the diagnosis of cancer (e.g. personalised medicine).
(the current GN-14 draft also removed the previously available NOTE)
● Addition of point g):
to be used for disease staging, where there is a risk that an erroneous result would lead to a patient management decision resulting in a life-threatening situation for the patient or for the patient’s offspring (e.g. Brain type natriuretic peptide).
● Update on point k):
in screening for congenital disorders in the fetus or embryo (e.g. Spina Bifida or Down Syndrome).
● Addition of point l):
in screening for congenital disorders in new-born babies where failure to detect and treat such disorders could lead to life-threatening situations or severe disabilities (e.g. G6PD)
IVD medical devices intended for self-testing or near-patient testing are classified as Class C, except those devices from which the result is not determining a medically critical status, or is preliminary and requires follow-up with the appropriate laboratory test in which case they are Class B.
Rationale: (no change)
Examples for Self-testing/near patient testing Class C: Blood glucose monitoring, blood gases.
Examples for Self-testing Class B: (no change)
● Update to point a):
products for general use in clinical laboratory, or accessories which possess no critical characteristics, intended by the product owner to make them suitable for in vitro diagnostic procedures related to a specific examination (e.g. buffer solutions, washing solutions, general culture media and histological stains).
● Addition of example to point c):
specimen receptacles (e.g. plain urine cup).
- ● APPENDIX A Decision Trees of the Classification Rules
HSA adjusted the decision trees of the risk classification based on the revision made of Chapter 5 Classification Rules
Feedback of the draft guidance can be sent by email to HSA_MD_INFO@hsa.gov.sg indicating "Feedback on GN-14" in the email subject header.