Clinical Investigations For Medical Devices And In-Vitro Diagnostic Kits

CliniExperts efficiently support the sponsor to launch their medical device and In-vitro diagnostic with reduced time in Indian market.

With increasing regulatory complexity and public scrutiny, CliniExperts can assist medical device companies to provide evidence, enhance patient security, and meet requirements according to MDR 2017.


Are you a Medical Device or In-vitro Diagnostic kits manufacturer and require a clinical trials, research, Evaluation, Evidence, or Study?

Clinical Investigation for Medical Devices

A Clinical Investigation is a systematic investigation or study in human subjects, undertaken to assess the safety and/or performance of a medical device.

Primarily required for risky medical devices (Class B, Class C and Class D) without predicates but may also be required for Class A medical devices.

Medical Devices which are new and are not approved by countries like USA, UK, EU, Japan, Australia and Canada,may also require Clinical investigation in India.

Types of Clinical Investigation Studies as per
the new Medical Device Regulations, 2017:

Pilot clinical investigation

Pilot trials, which are limited in scope and size, provide an insight into a medical device's effectiveness, safety, and actions. Still, these trials can't be used to make definitive claims about its therapeutic or mechanical properties. As such, clinical pilot trials are conducted at the beginning of medical device development when there is little to no experience in its use in humans.

A clinical pilot investigation’s goals typically include assessing feasibility, exploring eligibility criteria and how they can be applied to the pivotal randomized controlled trial, assessing potential harm (preliminary Safety Evaluations), studying medical device mechanism, validating an outcome measurement, using a defined medical device mechanism to validate a surrogate outcome, and evaluating the logistical aspects of the pivotal trial performance.

Pilot trials are useful in determining the feasibility and acceptability of a protocol designed for pivotal trials. This can be done with relatively few patients.

Three phases of Medical Device Pilot Clinical Investigation –

  • Product Viability
  • Preclinical Research and Prototyping
  • Product Development and Testing
Pivotal clinical investigation

A pivotal trial is a clinical investigation that seeks to prove the efficacy and safety of a new medical device for regulatory authorities to approve its marketing.


Pivotal clinical trials, also known as "registration Studies," are essential because regulatory authorities will review their results to decide if a medical device has the safety and efficacy to be approved and made commercially.

Clinical Performance Evaluation for In-vitro diagnostic medical device

The Clinical Performance Evaluation means the systematic performance study of a new in vitro diagnostic medical device on specimens collected from human participants to assess its performance (whether it is suitable for the purpose(s) and the population(s) for which it is intended).

Required for risky IVD (Class B, Class C and Class D)without predicates and may also be required for Class A IVD's.

Medical Device / In-vitro Diagnostic Kits Biocompatibility Evaluation

CliniExperts provides biocompatibility tests for MD / IVD. These biocompatibility investigations are GLP compliant with ISO 10993 standards and FDA guidelines. The IVD medical device/IVD biocompatibility investigation is a cost-effective and efficient resource for evaluating new MD/IVD devices.

Biocompatibility can be defined as an indication of how well a Medical Device is to the biological system. The ISO 10993-1:2018 Standard defines biocompatibility in terms of the "ability of a medical device or material to perform with an appropriate host response in a specific application."

The objective of conducting tests to test biocompatibility is to assess the suitability of a device to be used by humans and to determine whether using the device could have harmful impacts on the human body. impacts. As per ISO 10993: International Organization of Standards (ISO): "The primary aim of this part of ISO 10993 is the protection of humans from potential risks arising from the use of medical devices." (ISO 10993-1:2018). Before undertaking biocompatibility testing it is essential for the manufacturer to understand devices' materials, manufacturing, sterilization, and other procedures. The ISO 10993-1:2018 standard focuses on the chemical analysis before the in-vitro biocompatibility tests.

The IVD's that mandatorily require Clinical Performance
Evaluation includes but not limited to

Process Involved

Send the dossier of your application with the dossier to CDSCO as well as the Ethics Committee

Meet in person with SEC at CDSCO

Get approval from CDSCO under the Medical Device Rule 2017

Site deletion or addition associated notification; as appropriate

The annual status reports are submitted to the Central Licensing Authority (CLA)

Periodic Safety Update Report (PSUR) data submitted for two years after approval

Compile clinical performance evaluation report/ clinical investigation report application dossier

Review by the Subject Expert Committee (SEC)

Receive SEC recommendations from SEC

CTRI registration is required CTRI before enrolling the initial participant

Major Protocol amendments, as applicable

After the closing of the site- The final CSR submission

Send the dossier of your application with the dossier to CDSCO as well as the Ethics Committee

Meet in person with SEC at CDSCO

Get approval from CDSCO under the Medical Device Rule 2017

Compile clinical performance evaluation report/ clinical investigation report application dossier

Review by the Subject Expert Committee (SEC)

Receive SEC recommendations from SEC

Site deletion or addition associated notification; as appropriate

The annual status reports are submitted to the Central Licensing Authority (CLA)

Periodic Safety Update Report (PSUR) data submitted for two years after approval

CTRI registration is required CTRI before enrolling the initial participant

Major Protocol amendments, as applicable

After the closing of the site- The final CSR submission

Send the dossier of your application with the dossier to CDSCO as well as the Ethics Committee

Meet in person with SEC at CDSCO

Compile clinical performance evaluation report/ clinical investigation report application dossier

Review by the Subject Expert Committee (SEC)

Get approval from CDSCO under the Medical Device Rule 2017

Site deletion or addition associated notification; as appropriate

Receive SEC recommendations from SEC

CTRI registration is required CTRI before enrolling the initial participant

The annual status reports are submitted to the Central Licensing Authority (CLA)

Periodic Safety Update Report (PSUR) data submitted for two years after approval

Major Protocol amendments, as applicable

After the closing of the site- The final CSR submission

Send the dossier of your application with the dossier to CDSCO as well as the Ethics Committee

Medical Step 1

Compile clinical performance evaluation report/ clinical investigation report application dossier

Meet in person with SEC at CDSCO

Medical Step 2

Review by the Subject Expert Committee (SEC)

Get approval from CDSCO under the Medical Device Rule 2017

Medical Step 3

Receive SEC recommendations from SEC

/

Site deletion or addition associated notification; as appropriate

Medical Step 4

CTRI registration is required CTRI before enrolling the initial participant

The annual status reports are submitted to the Central Licensing Authority (CLA)

Medical Step 5

Major Protocol amendments, as applicable

Periodic Safety Update Report (PSUR) data submitted for two years after approval

Medical Step 6

After the closing of the site- The final CSR submission

Medical Device / IVD Clinical research and CRO services Offered ByCliniExperts

CliniExperts is equipped to develop and conduct studies and then use the results to meet the specifications set out by your Medical Device or IVD Manufacturing company's objectives in the most cost-effective, efficient, and efficient way.

  • MD/IVD Clinical Study Project Management
  • Study of MD / IVD site selection / recruitment
  • MD / IVD design input study to optimize the endpoints
  • MD / IVD documentation preparation and review (protocol, case report forms, patient information, clinical investigation brochure, required consent forms, etc.)
  • Management, identification, and control of qualified third-party independent parties (e.g., central laboratory) as required
  • Patient Insurance Arrangement
  • Competent Authority and Ethics Committee submission and liaison.
  • Regulatory Compliance management For MD / IVD
  • Monitoring of MD / IVD study (Study site visits at the beginning, regular monitoring visits, and closing-out visits)
  • MD / IVD Data Management Services (such as data management plan generation, data review, data transfers, etc.
  • Final report
  • Trial Master File maintenance
  • Quality Control

Frequently Asked Questions

Which class of Medical Devices require clinical investigation in India?

Clinical Investigation is required in India to examine all Medical Devices / in vitro diagnostic kits class A, B, D, and C; if the device falls within the scope of an investigational medical instrument that doesn't have a predicate, is made in India or if its a new Medical Device / in vitro diagnostic kits.

Form MD 24 is an application form to get the grant or permission to conduct a performance evaluation of a new in-vitro diagnostic kit.

The study must be initiated within one calendar year of receiving the permission. If permission is not granted, it will need to be approved in advance. The sponsor should submit an annual status report on the study to Central Licensing Authority. If the investigation ends, it should also be reported within thirty days.

Each individual, sponsor, clinical researcher, organization, and any other investigator participating in a clinical inquiry or his agent who has permission to do so shall keep the data, record, registers, etc., for seven years from the end of the clinical investigation. The Central Licensing Authority and any other authorized officers may require such information.

Clinical investigation of medical products is the process of obtaining data to evaluate the safety and performance of medical products in their intended use. This medical device performance study includes any side effects or risks the product may cause during its use.

Form MD 22 is an application to get the grant of permission to conduct clinical investigation of medical devices without predicate devices or new ones.

A “clinical investigation plan” is a document that describes the reasons, objectives, design methodology, monitoring, and statistical considerations. It also includes the proposed analysis, monitoring, conduct, and record-keeping for the clinical investigation.

Pilot studies for drug or device development are typically performed as a priori at the beginning of the process. They can be conducted when little or no clinical experience is available with the device or drug. Pilot studies refer to clinical trials that gather specific essential information about a device or drug before starting the pivotal trial. These trials will be used to make precise claims about safety and efficacy. A pivotal study is a clinical test that attempts to show the efficacy of a new drug, and it can be used to gain marketing approval from the regulatory authority. A pivotal clinical study aims to demonstrate that a novel experimental drug is more efficient than an existing standard-of-care drug.

The Central Licensing Authority can, if satisfied with the application, grant permission to conduct clinical investigation of medical device in Form MD 23.

According to the Global Harmonization Task Force, medical devices classified under the "Medical Devices Rules 2022" are categorized based on associated risks. Class A – Low Risk Class B – Low to Moderate Risk Class C – Moderate to High Risk Class D - High Risk

An investigational medical device in relation to a medical device, other than in vitro diagnostic Medical Device, means a medical device specified (i) which does not have its predicate device (ii) which is licensed by Manufacturing/Loan License/Import License. This license covers new intended use, new population, new material, or major design modification.

The application for a test license to import a medical device is filed under form MD-16.

The license pertaining to the import for test, evaluation, clinical investigations is granted using form MD-17 by the Central Licensing Authority.

The results of clinical investigation may not be required to be submitted where the investigational medical device is approved by the regulatory authorities of either the United Kingdom or the United States of America or Australia or Canada or Japan or EU and the said device has been marketed for at least two years in that country and the Central Licencing Authority is satisfied with the data of safety, performance and pharmacovigilance of the device.

No. Medical devices requiring clinical investigation but claiming substantial equivalence to a predicate device shall not be marketed unless the Central Licensing Authority has approved it.

Clinical performance evaluation is the systematic performance assessment of an in vitro diagnostic medical device using a specimen taken from humans to evaluate its performance.IVD Clinical investigation is the ability of the diagnostic kit to perform its intended function as claimed by the manufacturer. It includes the analytic and, where applicable the clinical performance that supports the intended purpose.