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Clinical Investigation for Medical Devices
A Clinical Investigation for Medical Devices is a systematic study conducted in human subjects to evaluate the safety, performance, and clinical benefits of a medical device. It provides essential clinical evidence for regulatory approval and market access. Clinical investigations are particularly important for medium and high risk devices that do not have an equivalent predicate device. In some cases, even low risk devices may require investigation if new technology or intended use introduces potential risks.
When Clinical Investigation for Medical Devices is Required
In India (Medical Device Rules, 2017):
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Required for new medical devices not approved in major regulatory markets such as the USA (FDA), EU (CE marking), UK (MHRA), Japan (PMDA), Australia (TGA), and Canada (Health Canada).
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Mandated when there is no predicate device or when the manufacturer intends to introduce new technology or a novel intended use.
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Overseen by the Central Drugs Standard Control Organization (CDSCO) and must be approved by the Drugs Controller General of India (DCGI) before initiation.
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Conducted as per Schedule Y and Good Clinical Practices (GCP) guidelines, with ethics committee approval.
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Essential for generating clinical data to support device registration and post-market approval.
In the EU (MDR 2017/745):
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Clinical investigations are required for most Class III devices and implantable devices, unless sufficient clinical evidence can be justified from existing data.
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Class IIb devices may also require clinical investigations if equivalence cannot be demonstrated or if sufficient clinical data is not available.
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Sponsors must submit an application to the relevant National Competent Authority and ethics committee in the EU Member State where the investigation will be conducted. (If you want to conduct a clinical investigation in India, the process is different and explained below section)
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Conducted in accordance with ISO 14155:2020 (Clinical investigation of medical devices for human subjects — Good clinical practice).
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Data from medical device clinical investigations form a key part of the Clinical Evaluation Report (CER), which is mandatory for CE marking.
When Clinical Investigation for Medical Devices is NOT Required
A clinical investigation for medical devices is not always required for every device. In certain cases, sufficient evidence from existing clinical data, equivalence to other devices, or compliance with regulations may be enough to demonstrate safety and performance. The following situations outline when a clinical investigation may not be necessary
A clinical investigation for medical devices is not always required for every medical device applied for MDR CE Certification. In certain cases, sufficient evidence from existing clinical data, equivalence to other devices, or compliance with regulations may be enough to demonstrate safety and performance. The following situations outline when a clinical investigation may not be necessary
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The device is a modified version of an existing product from the same manufacturer.
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The manufacturer has demonstrated equivalence of the modified device to the marketed one, approved by the Notified Body.
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The marketed device’s clinical evaluation is sufficient to confirm the modified device meets safety and performance requirements.
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The device is equivalent to another marketed product from a different manufacturer, with a contract ensuring full access to technical documentation.
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The clinical evaluation complies with Regulation (EU) 2017/745.
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The device has been lawfully marketed or put into service under Directive 90/385/EEC or 93/42/EEC.
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Medical device Clinical evaluations are based on sufficient clinical data.
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Evaluations follow relevant product-specific common specifications (CS), if available.
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Applicable to devices such as sutures, staples, dental fillings, orthodontic appliances, dental crowns, screws, wedges, plates, guides, pins, clips, or connection devices.
Types of Medical Device Clinical Investigation Studies
We help conduct your medical device clinical investigation in India
If you want to conduct a clinical investigation in India, the process is explained below
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In India, clinical investigations for medical devices are regulated by the Central Drugs Standard Control Organization (CDSCO).
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Sponsors (manufacturers or their authorized agents) must submit an application to the Drugs Controller General of India (DCGI) for approval.
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Approval from an Ethics Committee registered with CDSCO is also mandatory.
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The studies must follow Indian GCP guidelines and comply with the Medical Device Rules, 2017.
RegHelps SRC support foreign sponsors by:
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Preparing and submitting applications to CDSCO/DCGI.
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Coordinating with ethics committees.
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Designing and managing the study as per ISO 14155:2020 and Indian GCP.
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Ensuring compliance with both national and international requirements.
In summary, both India’s Medical Device Rules, 2017 and the EU MDR 2017/745 highlight the importance of clinical investigations to establish the safety and performance of high risk and innovative devices. While India focuses on new devices not yet approved in reference countries, the EU MDR mandates clinical evidence for Class III, implantable, and devices without sufficient supporting data.
At RegHelps SRC, we simplify this complexity by guiding sponsors through every step from regulatory submissions to ethics committee approvals, study design, monitoring, and final reporting. Whether you are planning a clinical investigation in India or the EU, our team ensures compliance with the latest requirements while helping you achieve timely market access.
service related FAQ’s
Any medical device or new in vitro diagnostic medical device that is imported or manufactured for the purpose of clinical investigation, clinical performance evaluation, testing, evaluation, demonstration, or training must be kept in containers with labels clearly indicating:
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Name of the product or code number
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Batch or lot number
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Serial number (wherever applicable)
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Date of manufacture
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Use-before date
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Storage conditions
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Name and address of the manufacturer
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The specific purpose for which it has been manufactured
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“For Clinical Investigation / Evaluation Only – Not for Sale”
Form MD-22: This is the application form submitted to the Central Licensing Authority (CLA) (i.e., DCGI under CDSCO) to seek permission for conducting a clinical investigation of a new medical device or an investigational medical device without a predicate device in India.
Form MD-23: If the CLA is satisfied with the application, it grants permission to conduct the clinical investigation through Form MD-23. This permission allows the sponsor to begin the study in accordance with an approved clinical investigation plan reviewed by a registered Ethics Committee.
Additional requirements:
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The clinical investigation must be registered with the Clinical Trials Registry – India (CTRI) before the enrolment of the first participant.
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The first participant must be enrolled within one year of the grant of permission; otherwise, fresh permission from the CLA is required.
