Client Overview
A medical device manufacturer specialising in catheter-based urinary care solutions develops innovative technologies to enhance patient safety and improve catheter performance. The company’s portfolio includes a novel; patented catheter device designed for specialised urinary care applications. Operating within a clinically sensitive device segment, the client focuses on advancing catheter performance, improving patient safety, and addressing unmet needs in urinary care through continuous product innovation.
Background
The client’s catheter device was new to the market, with limited published literature and no direct equivalent or similar device available for comparison. This made substantiation of clinical evidence more complex for EU market entry.
After submitting clinical documentation, the client received Notified Body comments requiring stronger clinical evidence, clearer scientific justification, and improved traceability across the response package.
Services in Scope
Notified Body comment response support
Clinical evidence gap assessment
Clinical claims support
Focused literature search and evidence identification
Clinical evidence substantiation
Clinical trial study summary support
Publication support for clinical data
Challenge
The client was addressing Notified Body comments for a novel catheter device, for which limited evidence supported the clinical evaluation.
The absence of a direct equivalent or similar device limited the use of comparative evidence and made it difficult to follow a standard literature-based substantiation pathway.
Available clinical data had to be carefully positioned to support device claims, strengthen scientific justification, and improve traceability across the response package.
The response also needed to connect literature findings, clinical trial information, product survey inputs, and device-specific claims in a clear manner aligned with Notified Body expectations.
Solution
1
Freyr reviewed the Notified Body comments and mapped the key evidence gaps, documentation weaknesses, and areas requiring stronger scientific justification.
2
A focused literature search was conducted to identify relevant clinical and scientific evidence for the novel catheter device. Despite the limited evidence landscape, targeted literature sources were identified to support the clinical evidence narrative.
3
Clinical investigation summarization was supported by reviewing the study status, recommending withdrawal where no patient recruitment was achieved, and preparing appropriate justification for ethics committee communication and publication of results.
4
The limited-evidence scenario was converted into a more structured, review-ready response package through survey support, clinical data positioning, publication-related documentation, and overall strengthening of the clinical evidence package.
Impact
Freyr helped transform a limited-evidence challenge into a structured, evidence-backed Notified Body response package with stronger substantiation, clearer traceability, and improved documentation readiness.
Improved clinical evidence clarity for a novel catheter device with limited published support.
Strengthened the scientific rationale despite the absence of a direct equivalent device.
Enhanced traceability across Notified Body comments, literature findings, clinical data, product survey inputs, device claims, and supporting justification.
Improved response readiness through a clearer, more review-ready evidence structure.
Reinforced the clinical evidence package with clinical trial study summary and publication-related documentation support.
No additional Notified Body comments were received post-resubmission.
