# Medical technology innovation classification framework

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/76701b16-a29c-4d3b-87eb-2f07ea1272ef
Type: Guidance
Published: April 8, 2024

> Following the Medical Technology Strategy published in February 2023, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has introduced a new medical technology innovation classification framework. This initiative was developed through collaboration between the government, industry partners, patient representatives, and health sector stakeholders to address the lack of standardized language regarding innovative medical devices. The framework establishes a unified vocabulary and clear criteria for defining innovation, allowing for a better understanding of how new devices compare to existing market alternatives. While the document does not focus on specific company inspections or regulatory violations, it identifies the need for clearer benchmarks to evaluate patient and systemic benefits. Under this strategic regulatory framework, the primary objective is to support the prioritization and adoption of high-impact technologies. Stakeholders are encouraged to align with this classification system to ensure that the most significant medical advancements are accurately identified and integrated into the healthcare system efficiently, ultimately improving patient outcomes through a more transparent and structured evaluation process.

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## Content

Under the Medical technology strategy , published in February 2023, we set out our intention to create alignment across the system on the language used to describe innovative medical technology. Over the last year, we have worked in collaboration with industry, the devolved administrations, patient representatives and the wider health sector to develop the medical technology innovation classification framework. The framework will: establish a common language for discussing innovation across the medical technology sector establish clear criteria for a device to be described as innovative in different forms clearly convey the change in a device compared to what already exists on the market and benefits to patients and the system support prioritisation and adoption of the most impactful innovations

## Attachments

- [Medical technology innovation classification framework](/government/publications/medical-technology-innovation-classification-framework/medical-technology-innovation-classification-framework)