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MHRA launches consultation on medical devices

Proposals for multi-use and regulation of AI/software

September 27th 2021

Tagged: DM Zone news

By Ailsa Colquhoun

GP teams are invited to comment on an Medicines and Healthcare products Regulatory Agency (MHRA) consultation to reform the regulation of medical devices.

From July 2023, new regulation aims to improve access to medical devices through data-driven assessment of risks and benefits and alignment with internationally recognised best practice and standards.

  • This will include:
  • new routes for regulation of software and artificial intelligence as medical devices
  • safe re-use and re-manufacture of medical devices, reducing use of single-use medical devices
  • reform of in vitro diagnostics (IVD) regulation to update classification and include an extended patient risk review.

The consultation closes at 11.45pm on Thursday 25 November.