Clinical Performance Evaluation for New IVD Medical Device
Ganesh Nair | Updated: Sep 16, 2022 | Category: CDSCO
In vitro diagnostic devices are the medical instruments that are used to conduct tests on samples extracted out of the human body; these include blood, tissue or cells. These devices shall examine the samples and give out results which are used by medical professionals to identify, treat and prevent diseases. The Medical device rules of 2017 have set rules for grant of permission to conduct a clinical performance evaluation of IVD medical devices. This article shall entail the process of obtaining a Clinical Performance Evaluation for a New IVD Medical Device.
Table of Contents
Which forms are applicable to Clinical Performance Evaluation for New IVD Medical Device?
There are two forms that are applicable to Clinical Performance Evaluation for New IVD Medical Device:
| S.no | Form Names | Purpose |
| 1. | MD-24 | The application for the grant of permission to conduct a clinical performance evaluation. |
| 2. | MD-25 | The permission granted by CLA for clinical performance evaluation of new in-vitro diagnostics. |
Who can apply for Clinical Performance Evaluation for New IVD Medical Device?
Any importer or manufacturer of a medical device can apply for the Clinical performance evaluation. They are required to submit their application to the Central licensing authority.
Classification for Clinical Evaluation of medical devices
| S.no | Class of medical devices | Requirements |
| 1. | Class A | The article must be suitable to carry out a specific examination in the invitro diagnostic devices. |
| 2. | Class B | The device should not have the capacity to display any information that is medically critical for the patient. The device manufacturer must confirm the preliminary test results of the device with lab reports to analyse the device’s performance. |
| 3. | Class C | The device in this category should be able to detect the presence of infectious agents, cerebrospinal/ blood fluids etc. Devices that shall be used to manage life-threatening diseases such as HIV and HCV.Devices that are used for screening of diseases in foetus.Devices used for monitoring levels of medicinal drugs, substances and biological components. |
| 4. | Class D | If the device is used to deal with any component that involves blood, cell tissue, or an organ. Then it shall fall under Class D of the IVD. Any devices that are used to deal with life-threatening diseases will be Class D devices. |
Pre-condition for Clinical Performance Evaluation
- The registered ethics committee must approve the plan for investigation before starting the clinical performance evaluation.
- The clinical performance evaluation must be in accordance with Good clinical practices as issued by the CDSCO.
- The study must begin within one year of receiving the permit. If the applicant fails, he will have to re-take permission for the study.
- An annual status report needs to be sent to the Central licensing authority.
- If for any reason, the study is terminated, the same must be informed to the Central licensing authority.
- The sponsor and any team member can be subjected to inspection by the authorised officers of CDSCO.
- If the applicant is found flouting any of these guidelines, then the Central licensing authority shall have the right to terminate the permission.
- The applicant shall have the right to appeal against the central government within the span of 30 days.
Documents required for Clinical Performance Evaluation of medical device
An applicant must have the following documents for the Clinical Performance Evaluation of a medical device:
- A detailed description of medical device
- Performance evaluation report the given by Central device testing lab
- Data retrieved from In house testing
- Performance evaluation plan
- Undertakings and case report as per the seventh schedule
- Approval received from the registered Ethics Committee
- Source of the sample
- Quantity of the sample
- Duration of evaluation
- The declaration from laboratories that shall conduct the health and safety measures for the device.
Process for obtaining Clinical Performance Evaluation of medical device
The applicant needs to follow these steps to obtain a Clinical Performance Evaluation of the medical device:
- The applicant must submit Form MD-24 to obtain permission for a Clinical Performance Evaluation of the medical device.
- The applicant must submit this form to the Central Licensing Authority (CLA), CDSCO[1].
- The applicant must attach relevant documents as mentioned in the list above. Along with this, the applicant must also pay the prescribed fee as mentioned in the Second Schedule of the MDR, 2017.
- If the applicant fulfils all the requirements, then he shall be granted approval for the evaluation in Form MD-25.
- If the CLA does not grant the application within the next 90 days, then the application will stand rejected.
- In case of rejection, CLA shall also give a proper reason for rejection.
- In case the applicant is an organisation, hospital or institute funded or run by the Central Government or the State government, no fee shall be charged.
Conclusion
The CDSCO carries out the clinical performance evaluation of medical devices to ensure that the in vitro diagnostic device is safe to be used on human beings. The trials conducted on these devices are compared with various reports to check their accuracy and reliability. The validity of permission for testing shall be valid for a period of one year, within which the applicant needs to start the study/evaluation.
Read our Article:Application Procedure for Class A and B Medical Devices
