Competition summary

Project Description

The aim of this programme is to support small and medium-sized companies (SMEs) that are currently producing or are developing products in the medical technology (MedTech), health technology (HealthTech), diagnostics (including in-vitro diagnostics) and software as a medical device markets to access regulatory related advice and support. This is currently very pertinent as the UK and the EU have seen changes to medical device and in vitro diagnostic device regulations which will affect the UK industry. This project seeks to offer support to the UK health technology industry to mitigate these changes.

Due to high demand, applications for the project closed on Thursday 31st March at 5pm GMT.

Companies can apply for grant funding for regulatory support up to £30,000. Regulatory support may include but is not limited to activities such as:

Other activities may be funded. If you are unsure if your activity qualifies then please contact the Health Technology Regulatory and Innovation Programme project support team (hereafter called the ‘Project Support Team’).

Regulatory 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

There will be a single round of grant funding made available which will start on 14th February 2022. Due to high demand, applications for the project closed on Thursday 31st March at 5pm GMT.

Applications will be funded on a first come, first served basis for companies that meet both the qualifying criteria and a minimum score threshold in their application.  For more information on the application process, see Section 4 - How to apply.

Funding must be used with a regulatory support provider based in the UK. If there is an intention to use provider outside of the UK, a justification for this will be required. An example of where you could find a list of regulatory support providers is the TOPRA website. The Project Support Team  cannot make a recommendation on suitable regulatory support providers. You will need to make you 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 our own purposes. SMEs applying for this funding are requested to notify their selected regulatory advisor about the Programme and communicate the need for the advising company to submit information to the Project Support Team.

Once you and the provider of regulatory support have entered into an engagement, the agreed support has been provided to you, and a valid invoice has been provided to the Project Support Team, 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 then use these funds to pay for the support you have received. It should be noted that payment is also conditional on you agreeing 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.

A final insights report will be published combining the input from all funding recipients to demonstrate the challenges faced by the UK HealthTech industry. Inputs will be anonymised to protect confidentiality unless you agree otherwise with the Project Support Team in advance.

This funding is being awarded under Article 3.2(3) of the Trade and Cooperation Agreement between the European Union and the United Kingdom. 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. Innovate UK have a description of this here.

We suggest you look at the section entitled “Special Drawing Rights (SDRs) and EU de minimis awards”. As you cannot receive more than 325,000 Special Drawing Rights over a period of three fiscal years, including the current year, you must declare if you receive funding through this grant programme, that it does not  cause you to exceed your Special Drawing Rights limit.

Project size

Funding is for up to £30,000 per company.