Competition summary

Regulatory affairs are complex and external advice is often needed, as the sector undergoes changes to medical device and in vitro diagnostic device regulations. The aim of this programme is to support small and medium-sized enterprises (SMEs) that are currently producing or are developing products in the medical technology (MedTech), diagnostics (including in-vitro diagnostics) and software as a medical device (SaMD) markets to access the regulatory affairs advice and support from third-party regulatory affairs specialists.  

This programme is funded by the Office for Life Sciences through the Department for Science, Innovation and Technology and delivered by CPI. Companies can apply for grant funding support of up to £30,000. Only regulatory affairs support is eligible for reimbursement and an illustrative list of activities is found on the Scope page. Other activities may be funded, but technical R&D and the purchase of equipment or software are not within scope. If you are unsure if your activity qualifies, then please contact the MedTech Accelerator: Rapid Regulatory Support fund project support team (hereafter called the ‘Project Support Team’). 

Regulatory affairs support providers cannot apply directly to the scheme but are encouraged to share this funding opportunity with any customers who might be eligible for this scheme and invite them to apply. 

Call process 

A single round of grant funding will be made available, starting on Wednesday 9th October 2024, and closing at midday on Thursday 31st October 2024.  

Applications will be funded by a competitive process, provided eligibility criteria and a minimum score threshold are met. There is a series of identifying, eligibility and scored questions. Applications are submitted through a Microsoft Form, which can be found here. .The maximum grant funding available is up to £30,000 per company, with £4.2 million available.  

We have capacity to accept and review a maximum of 300 applications, if this number is reached before the closing date, then we will close the competition early.  We will score and rank the first 300 applications received, and award funding to the highest scoring bids until the funding is fully allocated. We reserve the right to maintain a portfolio approach. 

Applicants must nominate a single regulatory affairs support provider to work with as only the costs from this provider will be reimbursed, up to £30,000.  

- Awarded funding should be used with a regulatory support provider based in the UK. If you intend to use a provider outside of the UK, you will need to justify why you cannot use a UK-based provider.  

- You must know which regulatory affairs support provider you wish to work with. The Project Support Team cannot make a recommendation on suitable regulatory support providers. An example of where you could find a list of regulatory support providers is the TOPRA website. You will need to make your own assessment and conduct due diligence on the adequacy and standing of the regulatory support provider you propose to use in your application.  

- The Project Support Team will conduct due diligence on the regulatory support providers for the purposes of administering this programme. SMEs applying for this funding are requested to notify their nominated regulatory affairs support provider about the programme and they may be contacted to request further information. 

A claim for reimbursement is made by submitting a copy of a valid invoice(s) from your nominated regulatory affairs support provider along with the required claim documentation and information. This will be checked by the Project Support Team and you will then be paid the eligible costs of that support - up to £30,000 (please see the FAQ for more information on VAT eligibility). You must use these funds to pay for the regulatory support within 30 days and for no other purpose. 

You also agree to complete a survey(s) and/or be interviewed by the Project Support Team about the support you are receiving and other challenges facing your business/industry. This will help CPI to identify the challenges faced by the UK MedTech industry on behalf of the programme funders. Inputs will be anonymised to protect confidentiality unless you agree otherwise with the Project Support Team in advance.