Clinical Investigation of Medical Devices

Medical Device Clinical Investigation / Trials

A medical device can be defined as a medical instrument that is not able to achieve its primary function in or on the body using pharmacological or immunological means. However, such devices may assist in fulfilling their intended function.

A clinical investigation of a medical device is the systematic examination of a medical device in human or animal participants to evaluate its safety, effectiveness, and performance. According to the Medical Device Rules of 2022 (MDR 2022), medical devices are classified into four categories based on their intended use and risk level. Medical devices can be classified as - low risk-Class A, low to moderate risk-Class B, moderate to high risk– Class C, and high risk– Class D.

It can be an instrument, apparatus, appliance, implant, material, or any other article. The manufacturer intends it to be used specifically for humans or animals for one or several of the following purposes:

• Detection, diagnosis, prevention, monitoring;

• The treatment or relief of any physiological condition, state or illness.

• Replacing or modifying the anatomy, or supporting a congenital deformity.

• Supporting and sustaining life

• Disinfection of medical equipment; or

• Control over conception.

Clinical Investigation of Medical Devices: Key Requirements

Clinical Investigation is mandatory for Medical Devices which are new and are not authorized by USA, UK, Japan, EU, Australia, and Canada Countries.

Any clinical investigation conducted by a sponsor cannot be done without the approval of the CDSCO/institutional ethics committee. Risky medical devices (Class B-C, Class C, and class D) are subject to clinical investigation without predicates. For Class A medical equipment, data on the clinical investigation may not need to be collected apart from a few exceptions. However, in some cases, the Central Licensing Authority(CLA) may consider data from clinical investigation necessary.

Clinical investigation can be omitted when the device that is being studied is recognized by the regulators of the United Kingdom, United States of America, Australia, Canada, or Japan and is being marketed for a minimum of two years in the mentioned country. In these situations, the following requirements must be met:

• The CLA must be satisfied with the evidence of safety and performance, as well as the pharmacovigilance of the drug accepted in the nation of the device.

• There is no evidence or theoretical probability on the basis of the current research that there is a difference in the performance and behavior of the device within an Indian population.

• The applicant must provide a written commitment to conduct post-marketing clinical studies/performance to ensure the safety and performance of this medical device under the protocols that have been approved by CLA.

Application To Get The Grant The Permission To Conduct Clinical Investigation For Medical Device – Form MD 22

An application to grant permission for clinical investigation of an investigational device for medical purposes must be made to Central Licensing Authority using Form MD-22. Sponsors should submit the form along with the information listed in the Seventh Schedule MDR 2022.

Permission To Conduct Medical Device Investigation – Form MD 23

If CLA is satisfied with all requirements, the Central Licensing Authority will grant permission to conduct clinical investigations for investigational medical devices in Form MD-23. Once permission has been granted, clinical investigation can begin based on a clinical investigation plan that has been approved by an accredited Ethics Committee.

Before enrolling the participant, the clinical investigation must be registered with the Indian Clinical Trial Registry. You must start the clinical investigation by enrolling the first participant within one year after the grant of permission. Otherwise, permission from the CLA is required.

Types Of Clinical Investigation As Per The Medical Device Regulations 2022

Pilot Clinical Investigation –
A pilot clinical investigation refers to a clinical investigation that is performed on human participants for the first time. Pilot clinical investigations are performed in a small group of patients with the condition or disease being studied to obtain specific information about the device prior to initiating the pivotal clinical study. A pilot clinical investigation is an exploratory study that provides information about the safety and performance of a device but does not provide support for any specific therapeutic or mechanistic claims. A pilot clinical investigation usually has the following objectives:

• Evaluation of feasibility (e.g., preliminary device performance).

• Examining eligibility criteria and their application to pivotal controlled investigations, ascertaining possible harm (preliminary Safety Evaluations).

• Studying device mechanism

• Validating a method to determine an outcome measure

• To validate a surrogate outcome, use a defined device method.

• Evaluation of the logistics of pivotal investigations for performance

Pivotal Clinical Investigation –
Pivotal clinical investigations are definitive or confirmatory study that gathers evidence to support the safety and effectiveness of the medical device intended for use. Pivotal clinical investigations are conducted in a larger population with the condition or disease being studied. Data from the pilot clinical investigation must also be submitted for a pivotal study. A clinical investigation must be conducted in India for any investigational medical device that is being developed in India. Data generated, and a Pilot clinical investigation should be done.

Pivotal studies are required for any investigational medical devices that do not have a predicate device but have been approved for sale or distribution in another country than India. These pivotal studies should be done primarily to show safety and effectiveness in Indian patients when the device is used as directed in the prescribing instructions. To ensure that data from the pilot study is consistent with data generated in India, pivotal clinical investigations on Indian subjects must be conducted before any data from the pilot study can be submitted. The sponsor should submit an annual status report on each clinical investigation to CDSCO, detailing whether it is currently ongoing, completed, or terminated.

Reference Medical Device Rule. 2017. MINISTRY OF HEALTH AND FAMILY WELFARE. (Department of Health and Family Welfare)