The role of clinical trials in medical device registration is to determine whether a new device or drug is safe and effective for people. To study various ways to use standard or approved current treatments so that they will be highly effective and easier to use or reduce certain side effects.

What’s the Purpose of Clinical Trials?

The Clinical Trials aim to assess the efficiency, safety, and comprehensive impact of new medicine treatments, devices or drugs on human health. They help us know whether or not the latest pharmaceutical product or treatment is safe to use. 

Why are Clinical Trials Important for the Medical Industry?

Clinical trials are crucial for the medical industry to improve patients’ health. Clinical trials benefit humans by clarifying whether the pharmaceutical item will work on humans; that definitely can not be known by testing it on animals. Yet, there are many reasons why clinical trials are important. Here, you can check out the points we have elaborated on why it is necessary. 

• Guarantee that new treatments and devices are safe.
• Provide regulator data that is based on evidence.
• Enhance patient care & other outcomes.
• Supports in increasing medical knowledge and innovation.

When are Clinical Trials Necessary?

Clinical trials are the primary resource to ensure any pharmaceutical is suitable for humans if it’s safe for everyone and good enough to use. Researchers benefit from clinical trials because, with this only, they can make their knowledge better and more vast. It will help them learn more ways to prevent diseases and detect more health conditions. You can simply read the list to know when clinical trials in medical device registration are necessary. 

1. Developing and expanding more new drugs, treatments and medical devices.
2. Checking new uses of previously existing medicines.
3. Easily comparable to checking the effectiveness of the current treatment.
4. Can evaluate the long-term safety and benefits of the treatment.

What is the Main Goal of Clinical Trial?

Clinical trials in medical device registration aims to procure human health by ensuring it is safe for all. Benefits researchers by making them informed about the uses in the general population. 

When is a Clinical Trial Generally Required?

A clinical trial for a medical device is generally required when there is an obvious medical need. Clinical Trials are generally required when:-

• New pharmaceuticals are being developed.
• Some major changes are going to happen in already existing drugs.
• Medication effectiveness or safety needs

What are the Types of Clinical Trials?

There are several types of Clinical Trials, such as prevention, diagnostic, screening, treatment, and quality of life trials. 

What Type of Clinical Trial is Best?

Certainly, the best type of clinical trial usually depends on the study objective and goals. Specially, Randomized Controlled Trials (RCTs) are said to be the gold standard as they minimize bias and offer huge amounts of data on the effectiveness of treatment. 

What are the Benefits of Clinical Trials?

Clinical Trials offer many benefits to individual participants and the medical community. Participants in clinical trials mostly get a hold of certain access to new treatments before they are widely available. These patients are accessible for special clinical staff care. Additionally, these clinical trials further the medical knowledge and innovation in healthcare.

Who Runs Clinical Trials in Medical Device Registration?

Majorly, principal investigators run Clinical Trials. Although multiple organizations can run clinical trials, they include pharmaceutical companies, hospitals, academic medical centres, and clinics. 

Who Audits Clinical Trials in Medical Device Registration?

Regulatory authorities, such as the FDA in the U.S.A. or the EMA in the EU, audit clinical trials. Certainly, there are Institutional Review Boards (IRBs) or Ethics Committees that audit clinical trials to ensure they comply with ethical standards and regulatory requirements.

Who Gives Permission for Clinical Trial?

Permission for Clinical trials is given by the national regulatory body, i.e. Central Drug Standard Control Organization (cisco) & Drug Control General of India (DCGI). 

Who pays the Cost of Clinical Trials in Medical Device Registration?

The study sponsors typically cover clinical trial costs, including pharmaceuticals, biotech companies, government agencies, non-profit organizations, and academic institutions.  

How are Clinical Trials Approved?

Clinical Trials are approved with a long list of processes that count, detailed study of protocols, ethics committee, submission of protocols to the institutional review board called IRB and other necessary approvals from regulatory authorities.

What is the Eligibility for Clinical Trials in Medical Device Registration?

Eligibility for Clinical Trials varies and depends on the specific criteria the trial protocol defines. Contacting the best regulatory consultants to get the latest details is better. 

Clinical Trials in Medical Devices Registration:

According to the National Ethical Guidelines, “a clinical trials in medical device registration is a medical tool which does not reach its primary intended action in or on the human body by immunological, pharmacological, or metabolic means but which may be helped in its intended function by such means”.

The medical device may be an instrument, appliance, apparatus, material, implant or other article, whether it may used alone or in combination, containing software or an accessory intended by its manufacturer to be especially used for human beings or animals for one or more of the specific purposes of:

• Detection, diagnosis, prevention, monitoring;
• Treatment or alleviation of any state of health, physiological condition, or illness;
• Modification or replacement or support of the anatomy or congenital deformity;
• Supporting or sustaining life;
• Disinfection of medical devices; or
• Control of conception.

Clinical Investigation of Medical Devices:

Application to perform a clinical investigation for the investigation of a medical device is to be made to the CLA (CDSCO) through Form MD-22 by a sponsor, along with the details mentioned in the Seventh Schedule (page 202). The permission to conduct a clinical investigation granted by the CLA for an investigational medical device through Form MD-23 (Rule 52 of the Medical Devices Rules, 2017)

The application fee for conducting a pilot or pivotal clinical investigation is INR 100,000, and the application fee is INR 25,0 for conducting a clinical performance evaluation00. Per rule 51(2), no fee is payable by any organization, institute, or hospital run or funded by the Central or State Government for the conduct of a clinical investigation.

Key steps for Conducting Compliant Clinical Investigation of Investigational Medical Device?

Here you can checkout the key steps for conducting clinical trials in medical device registration:-

• Get approval from the CLA.
• Get approval from a registered ethics committee.
• Prospectively register the trial with the CTRI (Clinical Trials Registry of India).
• Comply with The Medical Devices Rules of 2017, Guidelines of Good Clinical Practice, and ethical principles defined in the National Ethical Guidelines for Health Research and Biomedical Involving Human Participants 2017 published by the ICMR.
• The enrollment of participants in the clinical investigation should start within a year of getting approval from the CLA. Prior permission should be obtained from the CLA if the applicant cannot initiate enrollment within the prescribed time frame.

Clinical Performance Evaluation of New In Vitro Diagnostic Medical Devices:

Application to perform a clinical performance evaluation of a new in vitro diagnostic medical device is to be made to the CLA through Form MD-24 by the sponsor, along with the applicable fee (mentioned in the Second Schedule) and details (mentioned in sub-rule 2 of Rule 59, page 159). If all needs are satisfactorily met, the permission granted by CLA to conduct a clinical performance evaluation of new in vitro diagnostic medical devices through Form MD-25.

Regulatory Requirements for a Clinical Trial

According to the Medical Device Rule, clinical trials must be performed according to well-established international guidelines, like the international standard ISO 14155, “Clinical investigation of medical devices in humans – Good clinical practice”. 

The ethical orientation must depend on the principles of the current version of the “Declaration of Helsinki” of the World Medical Association. The general requirements for clinical trials are described in Article 62 of the MDR to demonstrate device compliance. An ethics committee established under national law that approval is required for the “Clinical trials” and “other clinical trials” and are thus subject to authorization. 

Protecting the subjects participating in the trial is the primary concern of clinical trials. Risks associated with the medical device should be identified before the planning and conducting of a clinical trial of the medical device by DIN EN ISO 14971 (Annex H) “Medical devices – Application of risk management to medical devices”. 

Purpose of the Clinical Trial in Medical Device Registration

According to Article 62 of the MDR, clinical investigations on medical devices are conducted for one or more of the following purposes:

• To establish and verify that a medical device is designed, manufactured and packaged to be appropriate, under normal use conditions, for one or more of the specific purposes mentioned in Article 2(1) and to perform as intended by the device manufacturer
• To establish and verify the clinical advantages of a device as specified by its manufacturer
• To establish and verify the clinical safety of the device and to identify any undesirable side effects associated with the device that may occur under normal conditions of use and to identify whether these pose acceptable risks compared to the benefits given by the device

When is a Clinical Trial Generally Required?

Here you can checkout the clinical trials that are generally required:-

• In the case of a new medical device with new properties and functions for which no other comparable medical device exists
• In the case of changes to a medical device that affect clinical safety and performance
• In the case of a new indication for a medical device (intended use)
• When using unknown and new materials
• For medical devices of risk class III (with exceptions, see section Class III and implantable devices) or implantable devices.