Navigating Regulatory Classification with Confidence
How C the Signs Established a Clear Regulatory Pathway for UKCA and European CE Marking Without Building an In-House Regulatory Team
Project Type: Classification Rationale Preparation
Introduction
C the Signs, an innovator in digital health and AI-powered clinical decision support tools for cancer care, needed clarity on the medical device classification of their Software as a Medical Device (SaMD) under both the UK Medical Devices Regulations (UK MDR) and the EU Medical Device Regulation (EU MDR). They partnered with SciMed, a specialist regulatory affairs consultancy, to deliver formalised classification rationales and strategic guidance. The outcome: a clear, confident route toward UKCA marking and CE marking, without the need to build an internal regulatory team.
Key Takeaways: How SciMed Formalised Classification with Clarity
Delivered defensible, dual-territory classification rationales aligned with current UK and EU guidance.
Aligned classification rationale preparation with long-term regulatory roadmap planning.
Reduced the in-house regulatory burden while supporting internal stakeholder confidence.
Strengthened the company’s pre-market regulatory positioning ahead of international expansion.
The Challenge: Classification Clarity for an Innovative Digital Health Tool
As an AI-driven SaMD, C the Signs’ product fell into a borderline classification space. Challenges included:
Interpreting how evolving UK MDR classification and EU MDR classification rules applied to their product’s functionality and risk profile.
Limited internal capacity to interpret guidance and prepare a defensible classification rationale.
Pressure to align compliance activities with R&D and commercial timelines.
Without expert regulatory classification support, the company risked taking a costly wrong turn in its regulatory submission preparation; potentially delaying market access and requiring substantial rework.
Get expert support on UKCA and CE classification for AI and digital health products; without the need to scale an internal team.
The Solution: Strategic Classification Rationales from Regulatory Experts
To address these challenges, C the Signs partnered with SciMed, who’s approach included:
Classification Rationale Preparation: Developing clear, structured classification rationales grounded in both UK MDR and EU MDR definitions and guidance.
Mapping classification logic to the current product functionality and its projected future evolution.
Delivering audit-ready documentation suitable for inclusion in the device’s technical documentation.
Advising on how future product iterations might affect the current regulatory pathway and classification status.
This strategy ensured compliance with current frameworks and built flexibility into the company’s regulatory strategy going forward.
The Results: A Well-Defined Pathway for UKCA and EU CE Marking
As a result of the collaboration, C the Signs:
Held defensible classification rationales intended to withstand scrutiny from UK and EU regulatory stakeholders.
Clarified its regulatory classification under both frameworks and thus reducing ambiguity and accelerating compliance activities.
Avoided costly missteps by integrating regulatory risk mitigation into its planning from the outset.
Freed up internal resources to focus on innovation while ensuring digital health regulatory compliance.
Positioned itself for future international growth through a robust and scalable regulatory strategy.
Conclusion: Partnering for Clarity and Momentum in Regulatory Strategy
C the Signs’ experience shows how a focused partnership with an expert regulatory affairs consultancy can transform complex classification challenges into opportunities for strategic clarity. For any manufacturer preparing for UKCA marking, European CE marking, or navigating AI medical device classification, early classification rationale preparation is essential. SciMed’s support provided a reliable platform for progress; reducing risk, accelerating timelines, and aligning the team on a clear pre-market regulatory positioning strategy.
