CETC MedTech Development Regulatory Support
UofG MedTech development landscape includes a wide range of medical products such as surgical instruments, software, hardware, firmware, scientific instruments and in-vitro diagnostics.
The regulatory requirements surrounding medical devices and software are complex and growing in line with UK legislation, which has led to steadily increasing demand for regulatory support for in-house and collaborative innovation projects with industry partners.
To address this need, CETC offers a comprehensive support system to fill critical gaps in the med/tech innovation journey through regulatory compliance assistance, including early-stage regulatory pathway mapping, support for the development of quality management systems (QMS), and the creation of technology-specific technical documentation.
The University of Glasgow's approach to MedTech development is well-coordinated with distinct operational units such as Living Laboratory, Digital Health Validation Lab (DHLV), Translational Research Initiative, or the Med Tech Fund supporting separate and complementary functions. There is a comprehensive network that supports both internal and external MedTech innovations from concept to commercialisation.
CETC MedTech Regulatory Support
- Medical device regulatory educational platform RegMetrics
- Regulatory Strategy Roadmap
- Guidance and signposting to resources for early phase development of a Quality Management System (QMS) framework and Technical File (TF)
- Help identify and engage with suitable external regulatory consultants
These CETC resources should be used alongside informal regulatory guidance and formal scientific advice from relevant regulatory bodies including the UK (MHRA), EU (EMA) and US (FDA) as applicable.
For support and signposting to resources related to MedTech regulatory input, please contact the CETC Innovation Start up Manager directly. Or book a drop-in session every Tuesday or Wednesday between 13:00 - 14:00.
Translational Research Initiative (TRI)
Translational Research Initiative (TRI)
Aligned with the Innovation, Engagement and Enterprise (IEE) strategy, TRI supports the translation of research into real-world impact. It offers early-stage product development grants and funding opportunity identification, expertise to help researchers develop partnerships, guide entrepreneurship processes and commercialisation strategies as well as access to training, events, and translational support opportunities.
Digital Health Validation Lab (DHVL)
Digital Health Validation Lab (DHVL)
Dedicated to advancing healthcare, DHVL provides the infrastructure and expertise to rigorously assess digital health technologies, supporting innovators in demonstrating technical robustness, clinical impact, and economic viability through well-designed clinical studies that evaluate performance, effectiveness, and user acceptability.
1. Medical device regulatory educational platform - Reg Metrics
RegMetrics is an educational platform for Medical Device Regulation. It is widely used by translational research services at universities and hospitals, as well as by MedTech incubators and accelerators to assist entrepreneurs in navigating their regulatory journey.
The software supports innovators by helping them determine if their device is a medical device, identify its classification, understand which regulatory requirements apply, discover useful standards, and find appropriate test houses for assistance. You can access overview of how RegMetrics works.
CETC secured a RegMetrics licence with Translational Research Initiatve (TRI) funding and is available to any individual with a UofG email address until April 2026 in the first instance.
Please create your UofG RegMetrics account here: https://www.reg-metrics.com/ . If you have any questions, please contact CETC Innovation Start up Manager.
2. Regulatory Strategy Roadmap
To establish the regulatory strategy, you need to confirm that a product is classified as an MD. Once confirmed, the next step is to determine its risk classification and the appropriate conformity procedure that outlines a streamlined workflow that summarises the key activities and considerations for the development, evaluation and commercialisation of MDs, aiming to facilitate their effective translation into clinical practice.
- Regulatory landscape
- Is my product a medical device?
- What is the classification of the device?
- Conformity procedures
- Essential Requirements (ERs) and General Safety and Performance Requirements (GSPRs)
- Standards
- The Technology Readiness Levels and definitions
Regulatory Strategy Roadmap outlines a streamlined workflow that summarises the key activities and considerations for the development, evaluation and commercialisation of MDs, aiming to facilitate their effective translation into clinical practice. The following sections explain the steps involved in MedTech development and the support available from CETC at each stage of the process.
2.1 MedTech Product Design and Development (TRL 1-4)
In the early stages of MedTech development TRL 1-4, the UofG innovator should clearly define the Unmet Clinical Need and Intended Use and initiate Risk Identification & Management Processes
2.2 Laboratory & Pre-clinical Technology Evaluation (TRL 5-6)
In the early research and development phase of a MedTech product TRL 5-6, it is crucial to determine if the research prototype meets all the essential safety and performance requirements. Additionally, it is important to identify the type of research data needed to satisfy the appropriate regulators regarding the appropriate systematic development and testing of the device in accordance with applicable MD legislation.
- 2.2.1 Evidence Generation at the pre-clinical stage of MedTech development (Patient, clinicians, health economics and regulatory engagement, prototype evaluation)
2.3 Clinical Evaluation and Clinical Investigation (TRL 7-8)
- 2.3.1 Evidence Generation at Clinical Evaluation and Clinical Investigation Stage
- 2.3.2 Clinical Trial Product
- 2.3.3 Clinical evaluation
- 2.3.4 Clinical investigation
- 2.3.5 IVD Performance Evaluation
- 2.3.6 Financial Implications
- 2.3.7 Regulatory Approval for conducting Clinical Trials
2.4 Commercial Adoption (TRL 9-10)
For a new medical device to progress beyond its primary clinical and performance evaluation (TRL 9-10), it requires commercial adoption outside of the UofG for NHS uptake. Before a product can receive market approval in the UK or Europe, it must be UKCA or CE marked. This certification confirms the product's compliance with health, safety, and environmental protection standards. Holding a patent on a device is effectively meaningless without a UKCA or CE mark.
For more information on the UKCA and CE Mark please refer to the “Regulatory Roadmap for UofG MedTech Developers “ guideline.
The University does not possess CE marks. Therefore, at this stage in the medical device lifecycle, the product transitions from being an 'in-house' development project. In practice, the resources needed for such an undertaking often exceed what UofG can provide, making commercial adoption essential.
Commercial adoption can occur through one of the following methods:
- Sold-out: The device is sold entirely to a company or manufacturer in a one-time deal
- Licensed-out: UofG retains ownership of the device or its components but grants a license to a company for marketing.
- Spin-out: the UofG innovator establishes a separate commercial entity to market the device
3. Early phase development of a Quality Management System (QMS) framework and Technical File (TF)
Innovators at the UofG who are in the early stages of MedTech development often concentrate their limited resources on the technical aspects of product development. Due to constraints in funding and manpower, there is a tendency and necessity to prioritise immediate product functionality over robust quality management practices. This approach can lead to significant challenges later, particularly when it comes to meeting regulatory requirements and ensuring product safety and efficacy.
3.1 Quality management system (QMS)
4. Help identify and engage with suitable external regulatory consultants
Regulatory advice is essential for MedTech development and marketing authorisation. Please note that this regulatory input has financial implications and should be planned earlier in research grant applications.
For a list of resources related to available external regulatory consultants and guidance on identifying required estimated funds to help with the development of a Quality Management System (QMS) framework and a Technical File, please contact CETC directly.
5. CETC MedTech Resources
Demystifying Medical Device Regulations - Workshop recording
This CETC event covered medical device regulations and development pathways across two sessions. The first session explained classifications and regulatory distinctions between various medical technologies (MDs, IVDs, SaMD, combination products), along with an overview of the regulatory framework including Notified Bodies and Competent Authorities. The second session focused on development pathways, addressing standards compliance, technology readiness levels (TRL), and practical steps to meet regulatory requirements when developing medical device technologies.