Frequently asked questions
Find out more about the Health Technology Regulatory and Innovation funding competition.
Who is funding this project?
The project is being funded by Innovate UK and is being delivered by CPI and ABHI
How much funding am I able to apply for?
You are able to apply for up to £30,000. This funding must be spent in one go, in full, with the approved regulatory service provider.
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. Examples of what this means are:
Participant A incurs costs of £120 (£100 plus £20 or 20% of VAT) – they should present £100 as an eligible cost if the business is VAT registered and reclaim the VAT incurred back from HMRC.
Participant B incurs costs of £120 (£100 plus £20 or 20% VAT) – they should present the £120 as project cost being the eligible cost if the business is not VAT registered and cannot reclaim it back from HMRC. Or for some reason is VAT exempt and never incurred VAT in the first place.
In both examples, the funding limit is £30k.
When will I receive the funding?
When the work is completed and you have received an invoice, you will send this to the Project Support Team who will reimburse you within an estimated 30 days to the value requested within the application or the value of the invoice, whichever is lesser.
How many times can I apply for funding?
Only one application per company or group is permitted. Any subsequent applications will be removed.
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 EU definition of an SME. 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 that are 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 producing and selling the technology yourself.
Are you prioritising any types of companies or products?
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. We will fund applications on a first-come, first-serve basis, providing the minimum threshold criteria is met.
What are Special Drawing Rights?
This funding is being awarded under Article 3.2(3) of the Trade and Cooperation Agreement between the European Union and the United Kingdom. The UK-EU TCA has agreed on funding allowances under Special Drawing Rights (SDRs). There is a subsidy threshold of 325,000 Special Drawing Rights (approx. £335,000) per individual company, business, or group over any period of three fiscal years, including the current year.
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). 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/
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 consultants – different companies have different needs. An example of the types of support you could use the funding for include:
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
What if the regulatory support work is not completed by 31st August 2022?
You may ask the company providing regulatory support for an invoice for the work completed so far, if it is the same value as requested at the application point or lower you will be reimbursed, providing you submit the invoice by the 31st August 2022.
Will I be notified if I am not successful? Can I request feedback on my application?
Due to the short timescales on the Health Technology Regulatory and Innovation Programme project and the high number of applicants expected, applicants will not be provided with feedback on their application.
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 in the application.
Does how much funding I ask for impact how my application is scored?
The amount of funding requested can be up to £30,000 and the amount of funding requested does not impact how the application is scored.
Who are the regulatory consultants? Can you make a recommendation of who to use?
CPI will not make any recommendations on the suitability of regulatory consultants for your business. It is the responsibility of funded SMEs to find a regulatory consultant to assist with regulatory advice required, and they must perform their own due diligence on the competence, terms of engagement and insurance cover levels of these companies
Can I use my funding to pay for support from more than one Regulatory Service Provider?
You can only reclaim costs from one regulatory service provider, and you must provide a single, valid invoice from that service provider before CPI will release funding to you. This is because CPI is required to carry out due diligence on both the you (the SME applicant) and your Regulatory Service Provider before approving your funding application; due to the volume of applications it is not practicable to permit more than one Service 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.
I am a regulatory consultant. 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.
How do I get in touch with the project team?