News

Health Technology Regulatory and Innovation Programme

Health Technology Regulatory and Innovation Programme
Funding, SME
Member News, Funding news

If you are an SME working in HealthTech, you can apply for up to £30,000 of funding for use with regulatory affairs providers, to help you navigate regulatory pathways.

On behalf of Innovate UK, CPI and ABHI have developed the Health Technology Regulatory and Innovation Programme to support small and medium-sized (SME) businesses to navigate the complex and ever-changing HealthTech regulatory landscape.

The programme will support SMEs that rely on external expertise to commercialise new products, or re-register existing products in-line with new regulatory requirements.

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.

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:

  • Global registrations
  • Mock audits
  • Quality
  • 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.

Applications open from 14th February 2022 and close on 31st May 2022. Applications will be reviewed on a weekly basis and awards made on a first-come, first-served basis if the minimum threshold criteria are met. Companies are encouraged to apply as soon as possible.

Source: Health Technology Regulatory and Innovation Programme – KTN (ktn-uk.org)

NEWS​

Related News

A Shift to Value-Based Procurement in Digital Health Solutions

16 May 2024
The shift towards value-based procurement in healthcare, focusing on long-term effectiveness and patient outcomes, rather than initial costs. The Dire...

Launching Moxiam+: the digital companion for an active and independent senior lifestyle

16 May 2024
Embark on a journey with Sweden-based Moxiam, the vanguard of digital health innovation dedicated to enriching the lives of seniors. Moxiam leverages ...

Romania – Transylvania Digital Health Ecosystem by FreshBlood is ECHAlliance Ecosystem of the Month – May

15 May 2024
This month we are featuring our Transylvania Digital Health Ecosystem by FreshBlood from Romania as our Ecosystem of the Month.

Revolutionising healthcare: how digitisation will transform care in the next 5 years

14 May 2024
On November 5-6, at the 6th Digital Health Society Summit, we'll explore how digitalisation is set to revolutionise healthcare in the next 5 years.

Dermatology from a broader view: mind-body connection

14 May 2024
Mind-body connection is a term that describes a connection between the mental layer and the body and in the case of a skin disease, the skin. Mind-bod...

CARE4DIABETES (C4D): Reducing the burden of non-communicable diseases

14 May 2024
Non-communicable diseases (NCDs) are responsible for 80% of the disease burden in the EU countries and the leading causes of avoidable premature death...

Become a member

Join ECHAlliance to amplify your organisation’s message, grow your networks, connect with innovators and collaborate globally.
 
First name *
Last Name *
Email Address *
Country *
Position *
First name *
Last Name *
Email Address *
Country *
Position *