On 19 September 2023, the UK  Government announced the launch of the Innovative Devices Access Pathway (“IDAP”) pilot scheme. The UK already has in place an Innovative Licensing and Access Pathway (“ILAP”) for medicines.  IDAP is the equivalent for medical devices, and is groundbreaking in the UK devices space. 

The IDAP scheme aims to improve access to innovative and transformative medical devices, and meet unmet patient needs.  Currently, it is in a pilot phase.  This pilot phase is open to applications from manufacturers seeking to develop and commercialize an innovative device in the UK.  Successful applicants will receive regulatory and market access advice and support at key stages of the development process from “IDAP partners.”  IDAP partners include regulatory and market access bodies such as the Medicines and Healthcare products Regulatory Agency (“MHRA”), National Institute for Health and Care Excellence (“NICE”) and the Department of Health and Social Care (“DHSC”).  The pilot is limited to up to eight innovative devices.  Applications for the pilot phase open on 25 September 2023 and close on 29 October 2023. 

Why apply for the IDAP?

The core aim of IDAP is to provide developers of medical devices with joined-up support that complies with regulatory requirements and accelerates market access to the UK State healthcare system.  In other words, IDAP aims to co-ordinate and accelerate the process by which developers of medical devices can place innovative devices on the UK market and gain reimbursement.

Successful applicants will receive non-financial support from IDAP partners to develop a Target Development Profile (“TDP”) roadmap.

In addition to MHRA, NICE and DHSC, IDAP partners include the Health Technology Wales (“HTW”), National Health Service England (“NHSE”), Office of Life Sciences (“OLS”) and Scottish Health Technologies Group (“SHTG”). 

The TDP roadmap will address specific targets in the regulatory and market access processes for the selected device, including:

  • quality management system support;
  • system navigation advice;
  • a fast-tracked clinical investigation;
  • joint scientific advice with partners;
  • support with Health Technology Assessments (“HTA”) for product realization and adoption;
  • safe-harbour meetings to discuss NHS adoption; and
  • exceptional use authorization granted by the MHRA, provided necessary safety standards are met.

Who is eligible to apply?

Applicants for the pilot scheme must meet (1) general eligibility criteria and (2) pilot criteria.

The eligibility criteria include the following:

  • the product must be a medical device (hardware or software);
  • lead applicants must have a right to market their product in the UK and intend to obtain authorization and market the device in the UK;
  • early-stage products must show proof-of-concept;
  • the applicant must have UK clinical investigation sites lined up and commit to working with IDAP partners to create a TDP roadmap; and
  • the applicant must provide evidence of ISO 13485 compliance (or equivalent). 

Importantly, the product cannot be a drug-device combination product, and applicants cannot be headquartered or operating in jurisdictions subject to UK Government Sanctions.

There are also four IDAP Pilot criteria:

  • Criterion 1: the intended purpose of the device should be for a condition that is life-threatening or seriously debilitating and where there is a significant patient need;
  • Criterion 2: the product must innovative and transformative;
  • Criterion 3: the product will provide system wide benefit; and
  • Criterion 4: the technology clearly helps to address one of the “Life Sciences Vision’s Healthcare Missions.”  These Missions cover a number of priority areas such as neurodegeneration/dementia, early diagnosis/treatment, cardiovascular diseases, respiratory diseases, the underlying biology of ageing and increased understanding of mental health conditions.

There is some overlap between the IDAP pilot criteria and the ILAP criteria.  However, IDAP appears to have more of a focus on sustainability and cost-effectiveness of the devices.  Additionally, the pathways focus on different health issues/missions.

How can applicants apply?


Prospective applicants must submit an application form, which encompasses the following areas: Eligibility, Company Information, Product Details, Regulation and Compliance, the IDAP Pilot Criteria, IDAP Support and Declaration & Submission. 

Applications can be submitted from 25 September 2023 until the deadline of29 October 2023.

A panel will select up to eight medical devices (which must all be at the development and prototyping stage) that it considers most likely to receive the most benefit from the expertise and tools offered in the pilot.  The panel will be made up of representatives from IDAP partners, healthcare professionals and patient representatives. It will notify applicants of its decisions from December 2023.

What is the potential impact of the IDAP?

The IDAP follows a similar pattern to the ILAP for medicines, which accelerates the time to market for certain medicines such as those with new chemical entities, biological medicines, and medicines with new indications or which have been repurposed.  The Government claims the IDAP will provide developers with “an integrated and enhanced regulatory and access pathway”, and the pilot aims to “test the main elements of the pathway” to assist development of the future IDAP structure. 

The launch of the IDAP follows a growing trend by the UK Government to streamline the market approval and market access processes for medical devices.  This has been traditionally more difficult to address for devices than medicines due to a number of factors, such as inclusion of a broad range of products and the fact that regulators do not authorize the pre-market approval of devices.  The UK may become a more attractive place to develop and launch innovative devices as this pathway should help to reduce the time to market and help secure reimbursement for the most promising medical devices, particularly those purporting to meet significant patient need.

Photo of Sarah Cowlishaw Sarah Cowlishaw

Advising clients on a broad range of life sciences matters, Sarah Cowlishaw supports innovative pharmaceutical, biotech, medical device, diagnostic and technology companies on regulatory, compliance, transactional, and legislative matters.

Sarah is a partner in London and Dublin practicing in the areas of EU…

Advising clients on a broad range of life sciences matters, Sarah Cowlishaw supports innovative pharmaceutical, biotech, medical device, diagnostic and technology companies on regulatory, compliance, transactional, and legislative matters.

Sarah is a partner in London and Dublin practicing in the areas of EU, UK and Irish life sciences law. She has particular expertise in medical devices and diagnostics, and on advising on legal issues presented by digital health technologies, helping companies navigate regulatory frameworks while balancing challenges presented by the pace of technological change over legislative developments.

Sarah is a co-chair of Covington’s multidisciplinary Digital Health Initiative, which brings together the firm’s considerable resources across the broad array of legal, regulatory, commercial, and policy issues relating to the development and exploitation of digital health products and services.

Sarah regularly advises on:

  • obligations under the EU Medical Devices Regulation and In Vitro Diagnostics Medical Devices Regulation, including associated transition issues, and UK-specific considerations caused by Brexit;
  • medical device CE and UKCA marking, quality systems, device vigilance and rules governing clinical investigations and performance evaluations of medical devices and in vitro diagnostics;
  • borderline classification determinations for software medical devices;
  • legal issues presented by digital health technologies including artificial intelligence;
  • general regulatory matters for the pharma and device industry, including borderline determinations, adverse event and other reporting obligations, manufacturing controls, and labeling and promotion;
  • the full range of agreements that span the product life-cycle in the life sciences sector, including collaborations and other strategic agreements, clinical trial agreements, and manufacturing and supply agreements; and
  • regulatory and commercial due diligence for life sciences transactions.

Sarah has been recognized as one of the UK’s Rising Stars by Law.com (2021), which lists 25 up and coming female lawyers in the UK. She was named among the Hot 100 by The Lawyer (2020) and was included in the 50 Movers & Shakers in BioBusiness 2019 for advancing legal thinking for digital health.

Sarah is also Graduate Recruitment Partner for Covington’s London office.

Photo of Ellie Handy Ellie Handy

Working with companies in the life sciences and technology sectors, Ellie Handy focuses on EU, Irish, and UK life sciences regulatory and commercial matters.

Ellie advises clients on regulatory issues including classification, biologics, orphans, paediatrics, GxP, market and data exclusivity, clinical research, labelling…

Working with companies in the life sciences and technology sectors, Ellie Handy focuses on EU, Irish, and UK life sciences regulatory and commercial matters.

Ellie advises clients on regulatory issues including classification, biologics, orphans, paediatrics, GxP, market and data exclusivity, clinical research, labelling and promotion, reporting obligations, medical devices, and digital health. Ellie also advises companies in the food, cosmetic and consumer products sectors regarding regulatory compliance and borderline issues. Ellie provides advice in relation to corporate transactions and restructuring, in particular performing regulatory due diligence.

Ellie represents and works with a wide range of clients working in the life sciences and technology sectors on both contentious and non-contentious regulatory matters.

Ellie’s pro bono work includes assisting charities. In addition to her role at Covington, Ellie spent three years working life sciences regulatory practice in London.

Photo of Raj Gathani Raj Gathani

Supporting clients in the pharmaceutical, healthcare, medical device and consumer products sectors, Raj Gathani’s practice is built around EU and UK regulatory and strategic advice.

Increasingly, Raj concentrates on post market-launch projects, such as advising on advertising compliance, communications, interactions with healthcare professionals…

Supporting clients in the pharmaceutical, healthcare, medical device and consumer products sectors, Raj Gathani’s practice is built around EU and UK regulatory and strategic advice.

Increasingly, Raj concentrates on post market-launch projects, such as advising on advertising compliance, communications, interactions with healthcare professionals and patients, pricing controls and reimbursement strategies particularly in the UK and the Republic of Ireland.

Healthcare, its structure and delivery are specialist practice areas for Raj, particularly having operated healthcare and pharmacy businesses for eight years prior to joining the firm. This experience enables Raj to provide in-depth advice to healthcare clients –particularly those in the digital health space – as well as other life sciences companies whose work engages medical practice, dispensing and health-services rules.