Each company can apply for funding of up to £30,000, which must be used to fund regulatory affairs support work obtained from a provider of regulatory support.
Companies receiving support
Payment is conditional on you completing a survey(s) or being interviewed by the Project Support Team about the regulatory support you are receiving and other challenges facing your business/industry.
Applicant eligibility criteria
Applications will only be accepted from and will be awarded to a single legal entity.
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 )
The regulatory affairs provider that you choose to provide your support has to be UK based, unless an appropriate justification is provided.
We are interested in supporting applications related to all aspects of regulatory affairs. We understand due to the changing regulatory landscape the difficulties associated with re-registering existing products in the marketplace and especially encourage applications from businesses facing this challenge, especially those involved with in-vitro diagnostics (IVD).
Number of applications
Only one application per company or company group is allowed.
A total of £6,390,000 is allocated to this project as direct support to companies (through the grant funding scheme).
We expect to provide a minimum of 213 awards, but this may vary. 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.