This initiative signals an important step towards a new regulatory framework for medical devices in the UK that
- protects public health,
- ensures access to MedTech innovations, and
- maintains an attractive market for the industry.
The framework
- ensures safe access to quality-assured medical devices,
- reduce the duplication of assessments by comparable regulators, and
- enables resources to focus on more innovative products that benefit patient health.
- allows manufacturers to start considering whether their devices will be eligible for the proposed alternative routes to market.
MHRA Strategic Direction 2023-26
There are many timetabled initiatives set out in the plan, but the one covered by section 2.6 is the most far-reaching. It promises that by 31 March 2025, the UK will have formalized new recognition pathways for UK device approvals that will complement existing national UK routes to market.
Risk-Proportionate Regulation
The MHRA aims to achieve “risk-proportionate regulation,” which will enable it to increase its regulatory oversight on high-risk medical products while at the same time reducing its regulatory oversight on products where there is “clear evidence of a lower risk to patients.”
A more significant proportion of self-declared processing will be possible by embedding lifecycle risk-proportionate approaches. This would mean that once safety and efficacy criteria are met, there will be an explicit allocation of responsibility to manufacturers.
Other timetabled initiatives are
- an improved regulatory management system;
- optimize MHRA service delivery times in priority areas, including scientific advice; and
- introduce new guidance and legislation.
- regulatory reforms, including the clinical trials framework and new provisions for point-of-care manufacture.
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Sources