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Innovative Device Access Pathway – Breaking it down

Breaking down The new Innovative Devices Access Pathway (IDAP) initiative – what we know so far

The MHRA have hosted a couple of webinars over the last few days about this new initiative and the IVDeology team joined and came together with their top take aways from the webinar. Here are some of the main points that were raised:

IDAP is designed to provide a pre-regulatory pathway to allow new medical technologies that address an unmet clinical need to get on the market quickly without compromising patient safety.

Currently in the pilot phase, 8 varied technologies will be selected to embark on this pathway. Diagnostics devices and SaMD (including AI) were called out as areas that will be considered. As well as addressing unmet clinical needs, the economic viability of a project, how affordable it is to the taxpayer, how wide a population it could benefit and how accessible it is for patients will be taken into consideration as part of the selection process. 

The IDAP pilot was launched on 18/09/23 and applications are invited via the MHRA website until the closing date of 29/10/23. Subsequently, the 8 technologies will be selected in December 2023 and discussions to develop Target Development Profiles (TDPs) for these technologies will take place between Jan and Apr 2024.

Please note that there is a 2-hour window in which to complete an application, and there is no ‘save’ facility. It is therefore recommended that the guidance is read through carefully first and some preparation work is done in advance of completion.

The aim of IDAP is to provide a streamlined approach to getting exciting new technologies on the UK market utilising a partnership between the MHRA, Health Technology Wales (HTW), the National Institute for Health and Care Excellence (NICE) and the Scottish Health Technologies Group (SHTG). The selected companies will have early conversations with decision-makers which will be extremely beneficial to the success of their product in the long-term.

A range of tools will be available to those companies that get accepted onto the pathway, covering areas such as:

  • Joint scientific advice to create a clinical development plan.
  • A service to support innovator engagement with clinical investigation.
  • Help with auditing of QMS to ISO 13485 standards.
  • Support to help innovators navigate the pathway.
  • An access forum to facilitate access of the technology into NHS use.
  • Where deemed appropriate by the MHRA and, once a clinical investigation trial has been conducted over a 6-month period, selected technologies will be granted early market access via an Exceptional Use Authorisation.
  • Following on from this, there will support on post-market surveillance requirements, further evidence generation for HTA (Health Technology Assessment) and docking with reimbursement pathways.
  • Just to re-iterate, to be considered for the programme, there needs to be an unmet clinical need for the technology and that it will be a real game changer for patients if it gets on the market quickly. A letter of support from clinicians will be required to that effect as part of the application process. 
  • Consider including within your application any evidence of the sustainable features of your device which may support the NHS ambitious net zero targets. These may be factored in the final selection decisions for otherwise equal applications.
  • The aim is to learn from the pilot as to how this programme will work long-term. It is the start of establishing an end-to-end innovative pathway in the UK and they hope, from March 2025, to have a sustainable system going forward.
  • This is an exciting and forward-thinking programme whose success will ensure that state of the art, innovative medical technologies can begin to benefit patients in the UK much earlier than is currently the case. 

If you’d like more information or support regarding any of the above, such as Quality management system implementation, to being regulatory ready for the market, you can email us on [email protected] or you can book a call via this link to speak directly to our team