What are the reliable CRO solutions available for conducting clinical trials of medical devices?
When a new technology is created for the medical industry, regulation agencies set a few rules for market acceptance that must be complied by the manufacturers, so, a Medical Device Clinical Trial pathway begins.
To perform the mandatory activities for regulatory compliance can be time and money consuming, and for that reason Contract Research Organizations are ready to assist manufacturers with quality clinical and documentation services.
Our reliable CRO solutions provide the expertise you need for a successful Medical Device Clinical Trial. We have a deep understanding of the regulatory environment and use the latest technology to ensure the success of your trials.
Medical Device Clinical Trial: types and stages
A Medical Device Clinical Trial or clinical investigation refers to a study involving one or more human subjects, conducted to evaluate the safety or performance of a medical device. These clinical trials play a vital role in reducing the financial burden on the healthcare system as they provide access to innovative treatments.
Both in the United States and the European Union, medical devices might be subject to mandatory clinical trials before they can be made available in the market. This requirement is applicable to specific risk classes:
- In the European Union, all implantable devices falling under Class III and Class IIb categories must undergo clinical investigations as outlined in the EU MDR (Medical Device Regulation).
- In the United States, the FDA (Food and Drug Administration) mandates that all Class III devices must undergo clinical investigations as part of the premarket approval (PMA) process.
Clinical trials can be conducted during both the premarket and postmarket phases of the device’s life cycle, serving as an important means of assessment.
Premarket Clinical Investigation
A Premarket Clinical Investigation is conducted during the preparation for approval stage. The data collected at a series of activities is used to prove compliance with safety regulatory agencies. Overall, the Premarket Investigation process may include a pre-clinical trial, a pilot and a pivotal study.
Pre-clinical Trial
Before a human subject can be involved in a clinical investigation, pre-clinical activities must prove the safety of the device. These activities may contain different steps, including:
- Bench testing: rigorous testing of the device in a controlled laboratory setting to assess its functionality, performance, and reliability.
- Technical testing: evaluation of the technical aspects of the device, such as its design, materials used, and manufacturing processes, to ensure compliance with regulatory standards.
- Computer simulations: utilizing advanced computational models and simulations, researchers can simulate the behaviour and performance of the device under different conditions, helping with the identification of potential issues and optimization of its design.
- Animal studies: animals are employed in pre-clinical studies to assess the device’s safety, efficacy, and potential side effects. These studies provide valuable insights into the device’s biological interactions and its impact on living organisms.
Once the manufacturer considers the device suitable for clinical trials, they must obtain approval for their proposed investigation.
Pilot Study
Pilot studies play a significant role in the early stages of device development, typically conducted before the finalization of device design. These studies are employed when nonclinical testing fails to provide initial insights into device functionality and clinical safety. Pilot studies involve a very small number of patients, often 10 or fewer.
The primary objective of pilot studies is to gather a wide range of information that can be utilized for various purposes, including:
- Identifying necessary modifications to the device or procedure based on real-world application and feedback.
- Optimizing the technique employed by operators in handling the device.
- Clearing the intended use by assessing the device’s performance and safety in specific patient groups.
- Refining nonclinical test plans or methodologies based on observed outcomes in the pilot study.
- Developing subsequent clinical study protocols by incorporating lessons learned from the pilot study.
The data obtained from a pilot study serves as a valuable foundation for making informed decisions and optimizing the overall development and evaluation process of the medical device.
Pivotal Study
Is a crucial study conducted to obtain conclusive proof regarding the safety and efficacy of your medical device. These investigations typically involve a larger sample of subjects than the pilot. The outcomes of the pivotal study are utilized to obtain regulatory approval of the product.
It is important to know that the pivotal stage is not always precede by a pilot study, as specific medical device clinical trials activities always depend on the nature of your technology and the regulation pathway you are perusing.
Post-market follow-up
PMCF surveys are effective in gathering post-market clinical data and offer insights into device performance and user experiences, facilitating the acquisition of feedback from both healthcare professionals and patients by employing a questionnaire-based approach.
The nature of the survey may vary depending on the circumstances. For lower-risk devices and well-established technologies, a more general survey on user feedback can be employed. However, for products falling into high-risk categories, manufacturers should consider conducting more specific survey activities.
The European Union’s Medical Device Regulation (EU MDR) includes a distinct regulatory pathway, specifically Article 74(1), which outlines the requirements for conducting a clinical investigation as part of the Post-Market Clinical Follow-up (PMCF) process.
EU Regulatory for initiating a Clinical Trial
The European Union Medical Device Regulation (EU MDR) has established three distinct regulatory pathways for manufacturers to navigate. These pathways determine the necessary steps to ensure conformity and obtain a CE marking, which is essential for medical device companies operating within the EU market.
In addition to fulfilling the regulatory requirements, for initiating a clinical trial within the EU is necessary to obtain a CIV-ID (Clinical Investigation Identifier) and secure approval from the relevant competent authority.
It is important to know that the CIV-ID will eventually be replaced by a Single Identification Number, which will be tracked through the fully functional EUDAMED database. Although the complete implementation of EUDAMED was initially scheduled for spring 2024, it is essential to stay updated with the latest developments and official announcements regarding its launch
CRO services for Medical Device Clinical Trial
When it comes to clinical trials strategies, having a highly skilled and efficient team is crucial. A Contract Research Organization can ensure the success of these process. These are the key responsibilities and expertise of a CRO team can offer:
- Project and Quality Management
- Research and Clinical Trial Assistance
- Regulatory Affairs Management and Operation
- Data Analysis
- Statistical and Biostatistical Indication
As a leading CRO, ECLEVAR stands out with its agile approach and more than 20 years of experience in conducting pre and post-market studies for medical devices. Our services are designed to offer cost-effectiveness, time savings, and efficient management of regulatory constraints. By partnering with ECLEVAR, you can leverage their expertise to bring your medical device one step closer to the market.
You can trust ECLEVAR to handle the Medical Device Clinical Trial you need while ensuring safety and performance for your product. Contact us to provide innovative solutions and help you navigate the complexities of the regulatory landscape and achieve successful product launch.
