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New regulatory pathway to come for health technology


Mark Say Managing Editor

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The Medicines and Healthcare products Regulatory Agency (MHRA) is preparing to launch a new regulatory pathway for the development of technologies to support patients.

Named the Innovative Devices Access Pathway (IDAP), it is set for launch later this year with the aim of removing uncertainty from the route to making the products widely available.

It will be run by MHRA with the National Institute for Health and Care Excellence (NICE), Health Technology Wales and the Scottish Health Technology Group.

MHRA said that, once IDAP is up and running, partners will use lessons learned from a pilot to develop the pathway, with a framework for innovators to generate evidence needed to achieve regulatory approval and health technology assessment decisions.

It has encouraged innovators of medical technology to begin to register by contact, [email protected].

Centre for innovation

Dr Marc Bailey, MHRA chief science and innovation officer, said: “The new IDAP will demonstrate how the UK regulator, health technology assessment and the healthcare system are working together to deliver safe, effective, and earlier innovative medical products to patients, establishing the UK as a centre for medical innovation.”

“We would welcome early interest from potential applicants, so we can keep them updated as this key partnership and pathway develop.”

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