Scope

Companies receiving support 

You must demonstrate that you are developing, or currently selling, a medical device, IVD device or software as a medical device or service (as defined in the section titled “Eligibility”) and that you need regulatory support for activities such as those outlined below.

If successful, you will receive grant funding of up to £30,000 that you must use to pay for regulatory affairs support and for no other purpose. The regulatory affairs provider that you choose to provide your support should be UK based, unless an appropriate justification is provided.

Activities in scope 

Regulatory support may include but is not limited to activities such as: 

• 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 

• Regulatory training for staff

Projects we will not fund 

We will not fund: 

• Technical research and development  

• The purchase of equipment or software, including QMS software or regulatory guidance software 

• Pharma projects will not be funded unless they relate to an IVD/companion diagnostic device.  

• Health or wellness devices which are not regulated as medical or IVD  devices 

• Non-UK registered companies or other legal entities such as Universities, Research and Technology Organisations (RTOs) or Catapult centres unless they have a separate spin-out company that is a UK registered company or other legal entity which is trading on a commercial basis in the UK.  

• Distribution-only businesses who do not manufacture or develop their own devices.  

Submissions made after the call for applications has closed will not be considered. We will also not pay claims for reimbursements made after the claim deadline.

Our decision on the projects we will fund is final.