Eligibility
Each UK MedTech SME can apply for funding of up to £30,000, which must be used to fund regulatory affairs support obtained from independent specialist with demonstrated regulatory affairs expertise.
Companies receiving support
Only UK-based SMEs are eligible to apply to this programme.
- Applications will only be accepted from and will be awarded to a single legal entity. Only one application per company or company group is allowed.
- Applications must be from a UK registered SME company which is developing or currently producing and selling MedTech 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 ) .
Funding
A total of £4.2m is allocated to this project as direct support to companies (through the grant funding scheme).
We expect to provide a minimum of 140 awards, but this may vary depending on the number and quality of application. The total funding available for the competition may change. The funders and the Project Support Team have the right to adopt a portfolio approach across the competition, whereby we reserve the right to distribute funding across different technology areas should there be multiple applications for similar products in the same market sector.
This funding is being awarded under Minimal Financial Assistance provision of the Subsidy Control Act 2022. There is a subsidy threshold of £332,000 per company, business, or group over any period of three fiscal years, including the current year. There is government guidance on this available here. We suggest you look at the section entitled “Minimal Financial Assistance”. As you cannot receive more than £315,000 over a period of three fiscal years, including the current year, you must complete a declaration, confirming you have capacity to receive up to £30,000 of funding through this grant programme, without exceeding your MFA limit.
Payment is conditional on you completing a survey(s) and participation in an interview if asked or being interviewed by the Project Support Team about the regulatory support you are receiving and other challenges facing your business/industry.