MHRA: proposed framework for international recognition of medical devices

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.

 

Contact This email address is being protected from spambots. You need JavaScript enabled to view it. for more information.

Sources

Whitepaper