A Medical Device/IVD CRO differs from a Pharma CRO in several ways—ranging from terminology and regulatory frameworks to the types of studies conducted. While both operate under shared principles of patient safety, clinical integrity, and data reliability, the aspects regarding compliance and market approval can look very different. Understanding these differences is essential when choosing the right partner for your clinical investigation.
In this article, some of the differences are highlighted. One of the easiest differences identified, lies in terminology. Pharmaceutical studies refer to their main study document as the "Clinical Study Protocol." In the medical device world, it becomes the "Clinical Investigational Plan," while in the in vitro diagnostics (IVD) space, it is called the "Clinical Performance Study Plan." Despite describing a similar purpose—the study’s design, conduct, and objectives—each term reflects its own specialized regulatory environment.
Beyond terminology, however, are more impactful differences regarding regulatory pathways, clinical evidence requirements, and the type of support teams need from their CRO partner. These aspects define how efficiently a study progresses and, ultimately, how smoothly a product reaches market readiness:
Guidelines/Standards
- Pharma clinical trials are governed primarily by ICH E6 (R3)/GCP guidelines.
- Medical Device studies adhere to ISO 14155:2020 standards, which cover medical device investigations.
- IVD performance studies follow ISO 20916:2019.
Regulatory Frameworks
In the European Union, three different sets of legislative regulations reinforce these distinctions:
- Clinical Trial Regulation, (EU No 536/2014)
- Medical Device Regulation (EU 2017/745)
- In Vitro Diagnostics Regulation (EU 2017/746)
Each regulation requires a different approach to submissions and compliance. Understanding the correct pathway ensures your study proceeds without unnecessary delays or regulatory setbacks.
Study Purpose and Design
- Pharmaceutical studies are often developed for the pre-market, innovative phases, designed for product approval.
- In Medical device studies post-market surveillance and observational investigations are more common in the EU, due to the MDR 2017/745 requirements.
- IVD performance studies are different in their setup and may utilize existing samples (blood, tissue), sometimes without direct subject contact.
This diversity in study purpose impacts all aspects from trial recruitment to data collection strategies and ethical review requirements. Choosing the right CRO means recognizing these differences, as studies are tailored to specific product categories and regulatory expectations.
Expertise and Client Support Needs
Pharmaceutical CROs typically collaborate with pharma companies that already possess extensive clinical trial expertise, dedicated regulatory teams, and clearly defined development strategies. These clients usually have infrastructures in place for global study management and compliance, enabling CROs to focus primarily on operational excellence—delivering large-scale, multi-country trials with precision and reliability.
Medical device manufacturers, in contrast, are often smaller or mid-sized companies bringing breakthrough technologies to market. Many are navigating the clinical and regulatory landscape for the first time, seeking a CRO that can provide both strategic direction and practical, hands-on support. From designing lean yet compliant investigations to preparing documentation for CE marking under the MDR, device-focused CROs act as an extension of the client’s team—translating technical innovation into clinical evidence.
IVD manufacturers face another set of unique challenges. Their studies require specialized knowledge of analytical performance, sample handling, and ISO 20916-compliant methodologies. Unlike pharmaceutical or traditional device studies, IVD trials often involve close coordination between laboratories, hospitals, and data management experts. An experienced IVD-focused CRO helps bridge these elements seamlessly, ensuring that each study delivers credible clinical performance data aligned with IVDR requirements.
Because medical device and IVD companies often operate within tighter budgets and timelines than big pharma, their studies demand creative solutions and operational efficiency. CROs specialized in these fields are designed to:
- Operate with flexibility and cost efficiency.
- Provide end-to-end guidance from protocol design to submission support.
- Align each study with MDR or IVDR requirements for clinical and performance evidence.
- Serve as long-term partners, empowering manufacturers to achieve regulatory milestones and market readiness.
This combination of flexibility, expertise, and strategic partnership enables medical device and IVD-focused CROs to help clients bring their innovations to patients safely, effectively, and on schedule.
Navigating medical device and IVD studies can be complex, but expert help is available. Reach out to Celien, for a free 30-minute consultation and discover how streamlined project management and regulatory insight can support your next study.