Clinical Performance Evaluation of IVD: Key Requirements
Clinical performance evaluation means the systematic performance study of a new in vitro diagnostic (IVD) medical device on a specimen collected from human participants to assess its performance.
Classification of In vitro diagnostic medical device
Classifications of IVDs are governed by the intended purpose of the devices.
Class A IVD - An in vitro diagnostic medical device shall be assigned to Class A:
If it is a reagent or an article which possesses any specific characteristic that is intended by its product owner to make it suitable for an in vitro diagnostic procedure related to a specific examination;
An instrument intended specifically to be used for an in vitro diagnostic procedure; or
A specimen receptacle.
Class B IVD -IVDs are assigned to class B, if it is intended to be used to obtain
Test results that are not for the determination of a medically-critical status
Preliminary test results which require confirmation by appropriate laboratory tests
Used for the assessment of the performance of an analytical procedure or a part thereof, without a quantitative or qualitative assigned value
Class C IVD -IVDs are assigned to class C, if it is intended for use in
Detecting the presence of, or exposure to, a sexually transmitted agent
Detecting the presence in cerebrospinal fluid or blood of an infectious agent with a risk of limited propagation; or an erroneous result that will cause death or severe disability to the individual or foetus
Pre-natal screening of women for rubella or toxoplasmosis
Screening for disease stages, for the selection of patients for selective therapy and management, or in the diagnosis of cancer
Human genetic testing, such as the testing for cystic fibrosis or huntington's disease
Monitoring levels of medicinal products, substances or biological components, where there is a risk that an erroneous result will lead to a patient management decision resulting in an immediate life-threatening situation for the patient being tested (for example, cardiac markers, cyclosporin or prothrombin time testing)
Management of patients suffering from a life-threatening infectious disease such as viral load of HIV or HCV
Screening for congenital disorders in the foetus such as down’s syndrome or spina bifida; intended to be used for self-testing; used for near-patient testing in a blood gas analysis or a blood glucose determination (anticoagulant monitoring, diabetes management, and testing for c-reactive protein and helicobacter pylori).
Class D IVD -In vitro diagnostic medical device intended to be used for detecting the presence of, or exposure to, a transmissible agent
That is present in any blood, blood component, blood derivative, cell, tissue or organ; in order to assess the suitability of the blood, blood component, blood derivative, cell, tissue or organ, as the case may be, for transfusion or transplantation
That causes a life-threatening disease with a high risk of propagation
If it is intended to be used for blood grouping or tissue typing according to the ABO system, the, the Duffy system, the Kell system, the Kidd system, the rhesus system (for example, HLA, Anti-Duffy, Anti-Kidd).
Application for grant of permission to conduct clinical performance evaluation of new in vitro diagnostic medical device - Form MD-24
To conduct any clinical performance evaluation in respect of a new in vitro diagnostic medical device on any specimen, including blood or tissue derived from human body, permission by the Central Licensing Authority is mandatory.
Clinical performance evaluation is required for risky IVD (Class B, Class C and Class D) without predicates. For Class A IVD, data on clinical performance evaluation may not be required, however in some cases the Central Licencing Authority (CLA), may consider such data necessary.
Clinical performance evaluation may be waived when the IVD is approved by the regulatory authorities of United Kingdom, United States of America, Australia, Canada or Japan and is marketed for at least two years in the above-mentioned country. However, in these cases the following should be fulfilled:
The CLA should be satisfied with the data of safety, performance and pharmacovigilance of the device approved in the respective country.
There should be no evidence or theoretical possibility, on the basis of existing knowledge, of any difference in the behaviour and performance of the device in Indian population.
The applicant would have to furnish an undertaking in writing to conduct post marketing study with the objective of safety and performance of such IVD as per protocol approved by CLA.
An application for grant of permission to clinical performance evaluation of new in vitro diagnostic medical device can be made to the Central Licensing Authority in Form MD-24 by a sponsor and should be accompanied with information specified in the Seventh Schedule of the MDR 2017. The information required is as follows:
Approval from an Ethics Committee, which is registered with the Central Licensing Authority
Source and quantity of samples which shall be used during evaluation
Device description including specification of raw material and finished product, data allowing identification of the device in question, proposed instruction for use, labels and regulatory status in other countries, if any
In house performance evaluation data used to establish stability, specificity, sensitivity, repeatability and reproducibility
Clinical performance evaluation plan stating in particular the purpose, scientific, technical or medical grounds and scope of evaluation
Case Report Form as specified in Table 6 of the Seventh Schedule
Undertaking by investigators as specified in Table 9 of the Seventh Schedule
The list of laboratories or other institutions taking part in the evaluation study
The scheduled duration for evaluation and, in case of devices for self-testing, the location and number of lay persons involved
An undertaking that the device in question conforms to the requirements of these rules, apart from aspects covered by evaluation and apart from those specifically itemised in the undertaking, and that every precaution has been taken to protect the health and safety of the patient, user and other persons
Performance evaluation report from a laboratory designated under sub-rule (1) of rule 19
Permission to conduct clinical performance evaluation - Form MD-25
The Central Licensing Authority, if satisfied, that the requirements have been complied with, grants permission to conduct clinical performance evaluation of new in vitro diagnostic medical device in Form MD-25. After grant of permission, clinical performance evaluation can be initiated based on clinical performance evaluation plan duly approved by a registered Ethics Committee.
Before enrolling the first participant, clinical performance evaluation needs to be registered with the Clinical Trial Registry of India. The clinical performance evaluation should be mandatorily initiated by enrolling first participant within a period of one year from the date of grant of permission, failing which prior permission from the CLA will be required to initiate clinical performance evaluation.
Annual status report of each clinical performance evaluation as to whether it is ongoing, completed or terminated should be submitted to CDSCO by the sponsor.
Medical Device Rule. 2017. MINISTRY OF HEALTH AND FAMILY WELFARE. (Department of Health and Family Welfare)