NAMSA Helped an AI-based Medical Device Software Manufacturer Transition from MDD to MDR Without Requiring a New Clinical Investigation

Two people discussing and signing a document at a desk with a laptop.

Client Background

A European MedTech company with an AI-based Medical Device Software (MDSW) intended to diagnose arrhythmia contacted NAMSA’s regulatory team. The company sought to perform a gap assessment to transition their clinical evaluation from MDD to MDR. Additionally, they aimed to expand their intended population to include a vulnerable population.

Project Scope

The company faced several challenges:

Transition their clinical evaluation documentation from MDD to MDR compliance.
Expand the intended use to a vulnerable population with insufficient clinical evidence.
Demonstrate scientific validity and safety for the expanded population without conducting a new clinical investigation.

The Solution

NAMSA’s regulatory experts and medical writers undertook the following steps to address these challenges:

MDD to MDR Gap Assessment:

Identified gaps in the existing clinical evaluation documentation and determine the additional clinical evidence required to support the expanded use to a vulnerable population.
Conducted a thorough review of the current clinical data, preclinical data, and existing literature. Compared the findings against MDR requirements to identify deficiencies.

PMCF Strategy Development:

Identified the need for additional clinical evidence to support the expanded use.
Delivered a PMCF strategy gap assessment containing approaches to evaluate how to generate the required clinical data and demonstrate scientific validity.
Outlined methods to obtain real-world clinical data required to demonstrate safety and performance in the expanded population.

Healthcare Professional Questionnaire:

Developed high-quality questionnaires to collect feedback from healthcare professionals. Focused on aspects such as usability, diagnostic accuracy, and patient outcomes.

The Outcome

NAMSA’s comprehensive approach and expertise in EU regulatory affairs helped the MedTech company transition their clinical evaluation documentation to meet MDR requirements effectively. By addressing the gaps identified during the gap assessment and providing tailored PMCF strategies, NAMSA ensured the client’s compliance and successful expansion of their intended use to a vulnerable population.

The manufacturer received updated and compliant clinical evaluation documentation.
Our PMCF strategy enabled the manufacturer to demonstrate safety and performance in the expanded population without requiring a new clinical investigation.
The manufacturer successfully showed compliance with the MDR and expanded their intended use to include a vulnerable population.