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