Frequently asked questions

1. Who is funding this project?  

The project is being funded by the Office for Life Sciences and the Department for Science, Innovation and Technology. It is being delivered by CPI, part of the UK Governments High Value Manufacturing Catapult. 

2. How much funding am I able to apply for?  

You can apply for a maximum of £30,000. This funding must be spent in full and only with your approved regulatory affairs service provider. You can conduct work valued at more than £30,000, but our reimbursement payment will not exceed £30,000 and you must fund the additional costs.   

3. Do my costs include VAT?  

The funding will reimburse eligible costs which may or may not include VAT, depending on whether your company is VAT registered. If a company is not VAT registered then VAT may be claimed. Examples of what this means are:  

An SME is awarded £30,000 funding under this programme.  They engage with an approved regulatory services provider and receive an invoice for £25,000 + VAT at £5,000  

• Participant A is VAT registered. They can reclaim £25,000 as an eligible cost and should reclaim the £5,000 VAT from HMRC in the normal course of their business.   
• Participant B is not VAT registered. They can claim costs of £30,000 (£25,000 plus £5000 of 20% of VAT) – This is because  the business is not VAT registered and cannot reclaim it back from HMRC.  This is known as irrecoverable VAT.  
• If the value of the invoice exceeds £30,000 (with or without VAT) we will reimburse a maximum of £30,000 and you will have to pay the balance. In all examples, the grant reimbursement funding limit is £30,000.  

4. When will I receive the funding?  

When you have received a valid invoice from your regulatory affairs provider, you will send this with supporting claim documentation to the Project Support Team for assessment. We aim to make payment to you within five weeks, and we will reimburse the value of funding awarded or the value of the invoice, whichever is lesser.  

5. How many times can I apply for funding?  

Only one application per company or group is permitted.  Any subsequent applications will be rejected.  

6. What types of companies can apply for funding?  

You must be an SME based in the UK and registered on Companies House in the UK.  We are using the Companies House Accounting definition of an SME, guidance is available here . To qualify as an SME, you must meet at least two of the following criteria:  

• Turnover: no more than £36m 

• balance sheet total (meaning the total of the assets): no more than £18m 

• average number of employees: no more than 250 

You must be a company that is developing or is currently selling a regulated healthcare product such as medical technology (MedTech), diagnostics or in-vitro diagnostics (IVD) or software as a medical device.  Companies producing or developing non-regulated wellness or healthcare devices or software are not eligible for this support. Pharma companies are only eligible if they are developing or selling medical technology or diagnostics such as companion diagnostics. Companies that distribute others' technology (distributors) are not eligible – to be eligible you must be developing or producing and selling the technology yourself.   

7. Are you prioritising any types of companies or products?  

We are interested in supporting applications related to all aspects of regulatory affairs.  We reserve the right to adopt a portfolio approach to distribute funding across different technology areas should there be multiple applications for similar products in the same market sector. 

We understand due to the changing regulatory landscape the difficulties associated with re-registering existing products in the marketplace and encourage applications from businesses facing this challenge. 

8. What is MFA?  

This funding is being awarded under the Minimal Financial Assistance (MFA) provision of Subsidy Control Act 2022. There is a subsidy threshold of £315,000 per company, business, or group over any period of three fiscal years, including the current year.  You can read more about Subsidy Control and MFA here: https://www.gov.uk/government/publications/subsidy-control-a-guide-for-beneficiaries/subsidy-control-a-guide-for-beneficiaries#minimal-financial-assistance-subsidies  

9. I have received funding in the past but I’m not sure whether it counts towards my Subsidy Control limit, how can I check?  

Please check your past grant funding letter(s) and look for mention of either De Minimis aid, or Subsidy Control / Small Amounts of Financial Assistance / Special Drawing Rights (SDR) / Minimal Financial Assistance.  CPI cannot check or offer advice on this matter but Innovate UK has published guidance which can be found here: https://www.ukri.org/councils/innovate-uk/guidance-for-applicants/general-guidance/funding-rules/ 

10. What regulatory support is in scope for the project?  

The project team does not want to be overly prescriptive in the type(s) of support you can get from regulatory affairs providers – different companies have different needs.  Example of the types of support you could use the funding for include:  

• Regulatory strategy  

• Guidance relating to standards,

• Guidance on MDR, IVDR, FDA,    

• Guidance on Technical File development  

• Mock audits,   

• Quality management systems 

• Clinical guidance pertaining to regulatory affairs,   

• Advice on reimbursement models,  

• Global registrations,   

• Contributions towards remedial action (for example electrical safety testing, biocompatibility testing etc)  

• Notified body costs 

11. What if the regulatory support work is not completed by the claim deadline?  

 You need a valid invoice from your approved regulatory affairs provider in order to claim the funding from us.  Due to the short timescales of this funding programme, we understand there may not be time to complete all of the work you have planned with your regulatory supplier ahead of the deadline for submitting a claim (which is 28th February 2025).  

We will accept and reimburse invoices from your approved regulatory affairs provider where they have been engaged but work has not yet been completed, on the understanding that funding we pay to you will be promptly paid to your approved provider, who will continue to delivering the services to their conclusion.  We recommend you discuss the matter of invoicing and payment with your regulatory provider as soon as possible in your engagement with them.  

We may not pay claims received after the 28th February 2025 deadline. It is therefore essential that you manage the process of receiving and submitting a claim or your organisation will be responsible for payment of the invoice.    

The funding provided by CPI to you under this funding programme is strictly for the purpose of paying for regulatory support and cannot be used for any other purpose.  We will carry out compliance checks on a random sample of applicants to ensure the invoices which have been presented have been paid, and if it is found to be the case that monies have been held or used for any other purpose, we will seek to reclaim the funding from you.   

13. Will I be notified if I am not successful? Can I request feedback on my application?  You will be informed if your application is not successful. Due to the short timescales of this programme and the high number of applicants expected, applicants will not be provided with feedback on their application.    
14. I have received confirmation of awarded funding, but I want to use a supplier who is not UK-based, can I do that?   If you must use a non-UK-based regulatory support company, then a good justification must be provided setting out why a UK based regulatory service provider cannot be used. Each justification will be assessed on its own merits by the Project Support Team.
15.  Who are the regulatory affairs providers? Can you make a recommendation of who to use?  CPI will not make any recommendations on the suitability of regulatory affairs provider for your business. It is the responsibility of the SMEs to find a regulatory affairs specialist to assist with regulatory advice required prior to application, and they must perform their own due diligence on the competence, terms of engagement and insurance cover levels of these companies.
16. Can I use my funding to pay for support from more than one regulatory affairs provider?  You can only reclaim costs from one regulatory affairs provider.  This is because CPI is required to carry out due diligence on both you (the SME applicant) and your regulatory provider before approving your funding application; due to the volume of applications, it is not practicable to permit more than one provider per SME.  It is acceptable for your service provider to subcontract part of their work to another company, however you must ensure all costs (including the subcontracted costs) are shown on their invoice to you, and the activities described match those outlined in your application to the programme or they may not be reimbursed. You may also work with more than one regulatory affairs provider, but you may not claim funding for work with other providers. 
17. I am a regulatory affairs provider. How can I access this programme?  You cannot apply directly to the programme, but we would invite you to share details of this with your clients for whom it may be of interest so they may apply. If they do so, you will then be asked questions to permit the programme team to conduct due diligence.  
18. How do I get in touch with the project team?  Email: Medtech.Accelerator@uk-cpi.com   
19. Under what terms and conditions is this competition operated?  Terms and conditions.