CDSCO or Central Drugs Standard Control Organisation, is a regulatory body which functions as a Central Licensing Authority (CLA) that provides the permission required for Clinical Performance Evaluation (CPE) for New In-Vitro Diagnostic Medical Devices. In this write-up, we are going to discuss Clinical Performance Evaluation for new IVD Medical Device. c
What are In-Vitro Diagnostics (IVDs) Medical Devices?
IVD products are devices & systems used to treat, prevent, or diagnose health conditions. These products are meant to be used in the collection & examination of biological samples such as tissue, blood, or saliva. An IVD device could be a regent, software, test kit, system, or instrument.
What are Form MD-24 and MD-25?
- MD-24 is an application form to grant permission to conduct a CPE.
- MD-25: It is the permission to conduct a CPE of a new In-vitro Diagnostics medical device (IVD).
Note: Any manufacturers or importers who want to conduct a clinical evaluation of new IVD can make an application form to the CLA.
Conditions for Conducting Clinical Performance Evaluation
Following are some conditions for Clinical Performance Evaluation:
- The Clinical Investigation plan needs to be approved through registration with the Clinical Trial Registry of India.
- The Clinical Evaluation needs to be conducted per the approved clinical evaluation plan & good clinical practice guidelines granted by the CDSCO.
- The analysis should be initiated within one year of getting the permission failing that, prior permission is required to start the analysis.
- The sponsor should submit the annual report of the analysis to the Central Licensing Authority (CLA), and if the study is terminated, it should be reported within thirty days.
- The sponsor and any person connected with the study are subjected to an audit by the authorised officers of the CLA.
- Any additional exemptions or conditions, in case any, imposed through CLA while granting the permission must be followed through the sponsor.
- If there is any injury to the subjects, the sponsor has to provide medical facilities to the subject.
- In case the sponsor fails to comply with the permission conditions, the CLA may suspend or cancel the permission either partly or wholly. The sponsor may appeal against such orders to the Central Government within thirty days, and the government will dispose of such appeal within sixty days.
Documents Required to Obtain Permission to Conduct Clinical Performance Evaluation
Following are some vital documents necessary to obtain permission to conduct a Clinical Performance Evaluation for a New IVD Medical Device:
- Complete Medical Device Description;
- Performance evaluation report by Central Device Testing Lab;
- In House Performance evaluation data;
- Performance evaluation plan;
- Case report form & undertaking as prescribed in the seventh schedule;
- Approval through the registered Ethics Committee;
- Quantity & Source of sample;
- Duration of evaluation;
- Laboratories participating in the study and undertaking that the medical device conforms to the rules & adequate precaution has been taken to protect the health & safety of the subjects.
Procedure to Obtain Clinical Performance Evaluation for IVD Medical Device
The permission to conducting of Clinical Performance Evaluation (CPE) for a new IVD medical device can be obtained through a sponsor by submitting an application Form MD-24 to the Central Licensing Authority (CLA) and submitting required essential documents and a fee prescribed in the Second Schedule of MDR, 2017. In case the application form complies with the statutory requirements, then the CLA will issue the approval in Form MD-25 or else, the application form will be rejected within ninety days from the date of application after allowing an explanation. No fees are required in case the organisation, institute, or hospital is run or funded through the Central Government or the State Government. In the public interest, the CLA has the authority to defer, abbreviate, and waive the requirement of CPE.
Important Tips for Conducting Clinical Performance Evaluation for IVD Medical Devices
Following are some important tips for conducting Clinical Performance Evaluation for IVD Medical Devices:
- The Applicant needs to have an undertaking from investigators.
- The Clinical Performance Evaluation plan should clearly state the objective, scientific, medical or technical grounds and scope of the evaluation.
- The Applicant needs approval from an Ethics Committee registered with the CLA.
The same issues can be faced in case the following points are left unchecked during the application procedure:
- The Applicant must register the Clinical Evaluation with the Clinical Trial Registry of India before enrolling the 1st participant for the Clinical Evaluation.
- The Clinical Evaluation plan needs to be initiated only after the registered Ethics Committee approves.
- The Clinical Evaluation should be conducted under the guidelines of Good Clinical Practices and the approved Clinical Evaluation Plan.
Clinical data for a particular device are continuously generated, collected, analysed, and evaluated through the systematic and planned process of clinical performance evaluation of medical devices. Additionally, it confirms a device’s effectiveness and safety, including any clinical benefits, for the manufacturer’s intended usage. Comparatively to the MDD, the MDR emphasises the extent and weighting of the clinical evaluation. For a device to be certified and given the CE mark, it must undergo a clinical review as part of the development process and adhere to the GSLA’s Essential Safety and Performance Requirements. As a result, every manufacturer of medical devices must go through this procedure with their product.
Read our Article:Top Differences Between Medical Devices and IVDs