IVD Performance Evaluation Studies
Are you looking for an experienced partner to generate accurate and trustworthy clinical evidence, compliant with applicable regulations and guidelines, for your IVD device?
Our IVD experts are happy to support you in your IVD Performance Evaluation Studies. Don’t hesitate to contact us for more information.
What are IVD Performance Evaluation Studies?
To safeguard the safety and performance of IVD devices, the IVD regulation (EU) 2017/746 and the WHO have defined requirements that manufacturers of IVD devices have to comply with.
According to the EU Regulation on In vitro diagnostic products, an IVD Performance Evaluation Study should consist of three aspects:
- Scientific validity report
- Clinical performance studies
- Analytical performance studies
At QbD, we use our in-depth knowledge of IVD regulations/guidelines to help our clients and partners generate high-quality clinical evidence, compliant with the applicable guidances, to demonstrate the performance of their IVD devices.
That’s why we offer analytical and clinical performance studies in collaboration with renowned clinical laboratories, blood banks and state-of-the-art private laboratories in Europe.
Our Performance Evaluation Study service includes:
- Qualification of and communication with the evaluation center
- Training and monitoring of the study site
- Drafting evaluation protocols
- Data source verification and data analysis
- Compiling performance study reports for the technical documentation of your IVD device
Our studies will be conducted in line with the standard ISO 20916:2019 in vitro diagnostic medical devices (clinical performance studies using specimens from human subjects) good study practice, and will comply with the national or regional requirements for ethics committee approval.
The design of the protocols and reports will be in line with the IVD Regulation, hence will meet the notified body’s expectations.
Why QbD Group?
In vitro diagnostics that are placed on the European market must meet the requirements of their respective European Regulations.
Conforming products will receive the CE mark as evidence of compliance, demonstrating their safety and performance.
Obtaining the required clinical evidence may be challenging…
- Save valuable time by becoming familiar with European and WHO requirements by relying on our IVD experts with more than 30 years of expertise in IVD regulation.
- Let go of your worries and enjoy our personalized step-by-step approach
- Meet the expectations of your notified body with an optimal study design and high-quality reports based on our extended expertise in organizing performance evaluation studies
- Increase the cost-efficiency of your studies through our customized approach: only pay for what you need
All studies can be designed in accordance with applicable standards, such as:
- ISO 20916:2019 standard
- Common specifications for class D devices
- CLSI standards
- WHO standards
We can provide you with the full Performance Evaluation Documentation or customized service. To date, all of our final applications for CE marking have been successful.
Yes, CE-marking studies are performed in European labs on European samples.
Yes, studies can be organized to be compliant with WHO standards.
Yes, near-patient testing compliant with IVD Regulation (EU) 2017/746 can be organized.
Yes, but this depends on the analyte. Needs will be assessed on a case-by-case basis.
Interested in our PES service? Don’t hesitate to contact us and provide the details of your request including scope, IFU (if available) and expected timelines. We will contact you shortly to discuss these details and further steps.