Guidance

IDAP pilot application guidance (now closed)

Updated 29 February 2024

The Innovative Devices Access Pathway (IDAP) pilot is designed to accelerate the development of cost-effective medical devices and their integration into the UK market.

The pilot will test the main elements of the pathway to provide informative learning and feedback that helps to build the future IDAP and wider development of an end-to-end innovation pathway as per the Medical Technology Strategy published in February 2023.

IDAP partners

The IDAP is being implemented through a consortium of partners, including:

• Health Technology Wales (HTW)
• the Medicines and Healthcare products Regulatory Agency (MHRA)
• the National Health Service England (NHSE)
• the National Institute for Health and Care (NICE)
• the Scottish Health Technologies Group (SHTG), part of Healthcare Improvement Scotland

The NHS Innovation Service

The NHS Innovation Service is an online platform for innovators and supports the UK’s Life Science’s Vision and the AAC’s ambition to speed up the adoption and spread of impactful innovations into the NHS, by providing innovators with free expert information and coordinated, tailored support.  

For more information you can access their website at: https://innovation.nhs.uk/

Rules and eligibility criteria for participation

Participants from all countries were able to apply, with the exception of those on the list of sanctioned countries. Note that only established products or solutions were considered for acceptance into the program.

See our full eligibility criteria.

Requirements for early-stage technology (prototype) and how early stages are supposed to be covered under ISO13485 as listed in the eligibility criteria

Following feedback, we have amended our guidance around the quality management system eligibility criteria for clarity.  

• Organisations must have a recognised quality management system in place, whilst certification is not mandatory, the system must satisfy the requirements of ISO 13485 or equivalent.

• When applications were made, we asked that applicants provided details of their formalised QMS along with when it was put in place and upload documents, for example, flow-charts, that demonstrate the maturity of the system. Your QMS system should go across the development life cycle of your product.

NICE definition of ‘near final’ prototype

The development spread stage may include: 

• Operational prototype developed
• Design verification / Laboratory studies conducted (with prototype)
• Performance evaluation study started, in progress or concluding (with prototype)
• Pre-clinical studies started, in progress or concluding
• Clinical investigation study started, in progress or concluding

Improvements on existing technologies

Improvements on existing technologies that would require regulatory approval for the UK market were acceptable to the IDAP pilot process, provided the product met the IDAP pilot criteria.

Companion diagnostics

The development of diagnostic tools to select patients for existing drugs was in scope provided all criteria were satisfied. 

The following were out of scope: 

• Co- development of drug device combinations

• Combination products regulated as medicinal products

Conditions outside the remit of the Life Sciences Vision Missions

Applications needed to fulfil all criteria in the application form. For the purposes of the pilot, the pilot criteria have been kept narrow as we could only select eight technologies. We expect to update the criteria for the full pathway launch in 2025.

Products approved in other regions but not in the UK 

Provided the technology met the criteria for the IDAP pilot, a product approved in other regions but not in the UK was within scope.  

The IDAP pilot criteria can be found on the IDAP webpage.

Age of letters of support from a clinical contact

There is no time limit on letters of support from a relevant health and/or care organisation or network.

Definition of “UK clinical investigation sites lined up”

Applicants were expected to have identified clinical investigation sites and ideally had signed agreements in place. A signed letter of intent from the study site(s) with estimated timelines of when the study is expected to start, and its duration was acceptable.

Next steps for the pilot

The IDAP pilot phase has been restricted to eight technologies/devices to ensure the selected products will derive maximum benefit from their inclusion on the pathway and to enable comprehensive insights and knowledge to be integrated into the future IDAP. 

Developing an end-to-end innovative pathway for the development and adoption of innovative technology into the NHS is a priority set out in the Medical Technology Strategy published in February 2023. The learnings from the IDAP pilot and other initiatives within this area will inform development of a rules-based pathway in the longer term.

QMS audit tool

We are currently in the scoping stage for a QMS support tool. Collaboration between the IDAP Partners and the UK Approved Bodies may change the remit and ownership of the tool in future.

Beyond the IDAP pilot: Prioritisation process for technologies at different stages of the development process  

To ensure diversity in technologies selected for the pilot, partners, with expert input, took a portfolio approach to selecting the final projects. We have not scoped how we prioritise technologies beyond the pilot stage. This will be determined by feedback from the pilot.

Route to Health Technology Assessment

All technologies will be subject to NICE’s standard topic selection and routing process to determine if are they eligible for HTA. Technologies selected for IDAP would have access to tools such as joint scientific advice and the HTA access forum to better support them with their evidence generation plans, HTA readiness, and their overall market access strategy.

UKCA status

Manufacturers must go through UK Conformity Assessment with an Approved Body to receive UKCA certification. However, we are exploring how we merge early engagement with the UK Approved Bodies into the IDAP pilot processes.

In line with current regulations, manufactures of general IVDs and Class I medical devices that are non-sterile and do not have a measuring function, can self-certify their medical device, and do not need to go through an approved body.

Conflicts of Interest

The usual processes to address conflicts of interest for individual partners would apply at the relevant stage of the pathway.

Clinical investigations: the future of UKCA performance evaluation requirements

We are exploring how we dovetail early engagement with the UK Approved Bodies in the IDAP pilot processes. Close collaboration and information sharing between the MHRA and the UK Approved Bodies will be key.

Timeframes for placing IDAP product on the UK market under EUA before manufacturers need to apply for regulatory authorisation with a UK Approved Body 

Timeframes will be product specific and included as a condition of granting the Exceptional Use Authorisation (EUA).

Claiming Exceptional Use Authorisation if you have FDA release

Regulations 12(5), 26(3) and 39(2) of the Medical Device Regulations 2002 permit the Secretary of State to authorise the placing on the market, or putting into service, of non-CE marked devices that have not undergone the necessary conformity assessment procedures in certain circumstances. This power can only be exercised where the Secretary of state (who MHRA acts on behalf of) is satisfied that to do so would be in the interests of the protection of health.   

A manufacturer can request to supply a medical device that does not comply with the law to protect health if there is no legitimate alternative available. This is called an exceptional use of a non-CE marked medical device.   

MHRA may authorise manufacturers to supply a non-compliant device the use of which is in the interest of protection of health under Regulation 12(5) of the Medical Devices Regulations 2002. This also applies for active implantable medical devices in regulation 26(3) and for in vitro diagnostic medical devices under regulation 39(2).  

Exceptional use authorisations will be exclusively issued directly to the manufacturer or the authorised representative of the medical device and only will apply to devices supplied to the UK. Our authorisations do not normally extend to distributor sales.

Selecting the final eight medical devices

All eligible applicants were evaluated through a panel of experts from the partner organisations and patients and public representatives. The panel evaluated the applications according to which products are likely to receive the most benefit from the expertise and tools offered in the pilot.

Prioritisation of companies by size, location and/ or stage of product development

To ensure diversity in technologies selected for the pilot, partners, with expert input, took a portfolio approach to select technologies of different clinical area, stages of product development and size of organisation. 

We did not prioritise applications by location. The IDAP was open to UK and international commercial and non-commercial developers with new health technology solutions.

Notification of application result

Applicants will receive updates about their entry via the email address they provided on their application.

Intellectual property rights for the submitted entries

Applicants will maintain the intellectual property of their products. IDAP partners will also have the right to share the application information within and between their organisations for evaluation purposes.

Personal information

All information shared with the IDAP program is confidential and protected under the UK data protection legislation.

Fees/funding

There is no fee for application or participation in the IDAP pilot.

The selection process and advice provided to applicants selected for the pilot from the consortium of IDAP Partners will be free of charge. Manufacturers are expected to fund their own studies and delivery of any clinical investigations.

Northern Ireland Market Access

The MHRA can exceptionally authorise medical devices for both the GB and NI markets under certain conditions. This means that Products coming through the IDAP pilot can be considered for exceptional use authorisations that will allow them to be placed on the whole UK market.

Northern Ireland companies applying for the IDAP

The IDAP is open to UK and international commercial and non-commercial developers with new health technology solutions. The MHRA can exceptionally authorise medical devices for both the GB and NI markets under certain conditions. This means that products coming through the IDAP pilot can be considered for exceptional use authorisations that will allow them to be placed on the whole UK market.

Contact

If you have any questions or concerns about the IDAP pilot, email IDAPEnquiries@mhra.gov.uk.