CellCarta’s expertise in IVD Regulation (IVDR) allows you to navigate the in vitro diagnostic (IVD) development process in the EU with ease.
Studies requiring assays and IVDs with a medical purpose must conform to IVDR, which outlines requirements for clinical trial initiation.
Our expertise in IVDR makes us the ideal partner to support IVD development and submission. We’ll work with you to implement effective strategies and personalized support, boosting submission success and trial efficiency.
To date, CellCarta has assisted with 37 Clinical Performance Study packages across 27 EU countries, totaling over 190 individual submissions.
Pamela Swatkowski, Vice President of Regulatory Affairs, provide valuable insight into the complexities behind IVDR’s requirements and submission process. Their knowledge and expertise provide the tools needed to overcome any regulatory challenges, streamlining the path towards successful IVD development.
Our expertise in assay development and clinical regulation can guide the transition of your investigational clinical trial assay to IVD CDx. Our CDx services include IVDR performance evaluation, supporting study submissions for major complex markets like the EU and US.
Wondering if your clinical trial assay is subject to IVDR legislation? CellCarta has developed a useful infographic to determine the situations in which your assay must adhere to IVDR requirements to aid with the submission process.
Our IVDR services are backed by an expert regulatory team.
Regulatory Expertise
Assay Development
Dynamic Services
Personalized Support
Global Market Understanding
In addition to our IVDR services, our expert-led services can enhance the success of your clinical trial submission.
Global sample management, transport, and biorepository services.
Our QMS is embedded across every stage of your study, from planning to reporting and archiving.
Support across all clinical trials, delivering expertise in biomarkers, regulation, data analytics, and more.
IVDR is applicable whenever testing occurs on EU patient samples, irrespective of laboratory location, and when a testing laboratory employs clinical trial assays developed in-house or utilizes a CE-IVD kit for off-label use, provided that the test results serve a medical purpose.
No, exploratory assays not intended for medical management decisions of patient care or treatment, are not subject to IVDR. These include stratification and endpoint analysis, or other exploratory assays, for which correlation with clinical parameters is investigated retrospectively without impact on patient treatment (medical purpose).
Our team’s expertise in IVDR and its previous version, IVDD, as well as assay and CDx development, ensures personalized support for your study. CellCarta has previously created or collaborated on 37 clinical performance study packages following IVDR legislation, across 27 EU countries, resulting in over 190 individual approvals.
