Health Technology Regulatory and Innovation Programme

23rd March 2022

If you are an SME working in HealthTech, you can apply for up to £30,000 of funding for use with regulatory affairs providers, to help you navigate regulatory pathways.

On behalf of Innovate UK, CPI and ABHI have developed the Health Technology Regulatory and Innovation Programme to support small and medium-sized (SME) businesses to navigate the complex and ever-changing HealthTech regulatory landscape.

The programme will support SMEs that rely on external expertise to commercialise new products, or re-register existing products in-line with new regulatory requirements.

The aim of this programme is to support small and medium-sized companies (SMEs) that are currently producing or are developing products in the medical technology (MedTech), health technology (HealthTech), diagnostics (including in-vitro diagnostics) and software as a medical device markets to access regulatory related advice and support. This is currently very pertinent as the UK and the EU have seen changes to medical device and in vitro diagnostic device regulations which will affect the UK industry. This project seeks to offer support to the UK health technology industry to mitigate these changes.

Companies can apply for grant funding for regulatory support up to £30,000. Regulatory support may include but is not limited to activities such as:

  • Global registrations
  • Mock audits
  • Quality
  • Clinical guidance pertaining to regulatory affairs
  • Technical guidance relating to standards
  • Guidance on MDR, IVDR, FDA
  • Advice on reimbursement models
  • Guidance on Technical File development
  • Contributions towards remedial action (for example electrical safety testing, biocompatibility testing etc)
  • Notified body costs.

Applications open from 14th February 2022 and close on 31st May 2022. Applications will be reviewed on a weekly basis and awards made on a first-come, first-served basis if the minimum threshold criteria are met. Companies are encouraged to apply as soon as possible.

Source: Health Technology Regulatory and Innovation Programme – KTN (ktn-uk.org)

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