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.

CETC secured the RegMetrics licence with the 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/ 

2. Regulatory Strategy Roadmap

To establish the regulatory strategy, one first needs 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 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.

2.3 Clinical Evaluation and Clinical Investigation (TRL 7-8)

 TRL 7-8

 

2.4 Commercial Adoption (TRL 9-10)

For the 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 (link to GUI_85.001 here).

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)

3.2 Technical Documentation

 

 

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.