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.

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.

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.

Other activities may be funded. If you are unsure if your activity qualifies then please contact the Health Technology Regulatory and Innovation Programme project support team.

There will be a single round of grant funding made available which will start on 14th February 2022 and will close on the 31st May (12:00 midday GMT) 2022.  Applications will be funded on a first come, first served basis for companies that meet both the qualifying criteria and a minimum score threshold in their application.

Applications must be from a UK registered SME company which is developing or currently producing and selling Health Technologies as they are outlined in the Medicines & Medical Devices Act 2021 (https://www.legislation.gov.uk/ukpga/2021/3/enacted) or with EU CE Mark requirements set out in medical devices Regulation (EU) 2017/745 (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745 ) or in vitro diagnostic medical devices Regulation (EU) 2017/746 (https://eur-lex.europa.eu/eli/reg/2017/746/oj ) .

You must demonstrate that you are developing, or currently selling, a medical device, health technology, IVD. etc (as defined in the section titled “Applicant”) and that you need regulatory support for activities such as those outlined in the section titled “Project Description”, which can be found in the Competition summary. If successful, you will receive grant funding of up to £30,000 that you can use to pay for the support received from a regulatory affairs support company. You and your provider must be able to complete this support by 5pm GMT on 19th August 2022.