How Regulatory Requirements Impact Medical Device Database Builds in the US and EU

Understanding the Role of Regulations in Medical Device Studies 

Medical devices are essential in modern healthcare, ranging from simple bandages to advanced implantable technologies like pacemakers and robotic surgical systems. Before these products can reach the market, they must comply with stringent regulatory requirements, particularly those set forth by the FDA (United States) and EU MDR (European Union Medical Device Regulation). 

These regulations significantly impact the database build process in clinical trials for medical devices, influencing how data is collected, stored, managed, and reported. 

Device Risk Classification: A Foundation for Database Strategy 

The FDA categorizes devices into three classes based on their risk levels: 

Classification	Risk Level	Requirements	Examples
Class I	Low	General Controls	Bandages, Surgical Tools
Class II	Moderate	Special Controls (510(k))	Infusion Pumps, Wheelchairs
Class III	High	Premarket Approval (PMA)	Pacemakers, Implants

In the EU, the MDR (Regulation 2017/745) now mandates more rigorous post-market surveillance and safety monitoring, driving the need for robust data systems capable of supporting long-term and real-time safety reporting. 

Why Medical Device Database Builds Are Unique 

Building a database for a medical device trial is not the same as for a pharmaceutical study. Device trials typically have smaller sample sizes but complex data requirements, especially when involving long-term follow-up, post-market studies, and unique device identifiers (UDI-DD). 

A well-executed medical device database build ensures compliance with both FDA and EU MDR standards, supporting safety, effectiveness, and traceability throughout the device’s lifecycle. 

Key Components of a Medical Device Database Build 

1. Comprehensive Data Planning

Database builds must integrate structured data (via eCRFs/EDC) and unstructured data (e.g., imaging, ePROs, device-generated data). Using ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate) ensures data integrity in alignment with GCP. 

2. Regulatory-Specific Configuration

Device-specific information, like UDI identifiers, must be built into the EDC platform. This helps with adverse event tracking, device recalls, and regulatory reporting. 

3. Customization by Trial Design

• Bilateral case support: Allow for data collection from both limbs/organs within the same patient ID. 

• Role-based CRF access: Tailored visibility for roles like Independent Assessors. 

• Multi-protocol support: Designs should accommodate future protocol amendments, which are common in device studies. 

4. Integrated Lab and Safety Reporting

• Central and local lab data can be normalized using built-in conversion factors. 

• Alerts for out-of-range lab values based on age/gender reference ranges. 

• Safety Tracker and automated email alerts streamline AE and Device Deficiency reporting to regulatory bodies. 

Choosing the Right EDC System for Your Device Trial 

A successful EDC system for device trials must: 

• Be cost-effective and scalable. 

• Support decentralized trials and real-time analytics. 

• Easily integrate with IRT systems and other APIs for device assignment tracking. 

Example: Integration with IRT 

Devices assigned in the IRT system (using lot numbers or catalog numbers) are automatically linked to subjects in the EDC, ensuring traceability and data accuracy. 

How BioBoston Consulting Supports Database Builds for Medical Devices 

At BioBoston Consulting, we specialize in customized clinical data management solutions for medical device trials across all classes (I–III). Our team has the regulatory knowledge and hands-on expertise to design cost-efficient, compliant, and scalable databases. 

What Sets BioBoston Consulting Apart? 

• Global ePRO libraries segmented by region. 

• Single-database solutions that support multi-site and multi-regional trials. 

• Experience with diverse franchises using global CRF libraries for streamlined CRF versioning. 

• Strong emphasis on data accuracy, system usability, and regulatory readiness. 

Cost Efficiencies Through Smart Design 

• Reusable forms and configurations reduce set-up time. 

• Automated tracking and alerts lower manual workload. 

• Lessons from past device trials help streamline study timelines and lower costs. 

 

Start Your Device Trial Strong — Partner with BioBoston Consulting 

Whether you are preparing for a Class I feasibility study or a Class III PMA trial, BioBoston Consulting provides unmatched expertise in medical device database builds and clinical data management. From protocol to approval, we help you navigate the complex regulatory landscape in both the US and EU with precision and efficiency. 

🔹 Contact BioBoston Consulting today to transform your clinical data into regulatory success.
🔹 Let’s build a better, safer future for medical technology — together.