The article provides an overview of the new regulatory framework introduced in the United Kingdom as a pilot project.
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The Medicines & Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the Innovative Devices Access Pathway (IDAP).
The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance thereto.
At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations.
The authority also reserves the right to introduce changes to the guidance, should such changes be reasonably necessary to reflect corresponding changes to the underlying legislation.
Innovative Devices Access Pathway Pilot: Introduction
The UK is launching a pilot phase for a new initiative – the Innovative Devices Access Pathway (IDAP).
The primary goal of this initiative is to address clinical needs that have so far remained unaddressed within the National Health Service (NHS).
This will be achieved by fostering the growth and development of innovative and transformative medical devices.
IDAP aims to streamline patient access to revolutionary medical equipment and solutions. Its objective is not only to test the main features of the pathway but also to gather insightful feedback that will help develop the future design and execution of the IDAP.
Furthermore, it offers both local and international developers of new health technology solutions the chance to partake.
The guidance published by the MHRA further outlines the key features of the new pilot project. According to the document, they include:
Support from IDAP Partners
Qualified applicants can look forward to receiving support during critical phases of their product’s design and development.
This assistance will come from a consortium of partners involved in the IDAP. The IDAP’s coalition consists of a wide range of organizations including:
- Department of Health and Social Care (DHSC)
- Health Technology Wales (HTW)
- Medicines and Healthcare products Regulatory Agency (MHRA)
- National Health Service England (NHSE)
- National Institute for Health and Care Excellence (NICE)
- Office of Life Sciences (OLS)
- Scottish Health Technologies Group (SHTG)
Benefits for Successful Applicants
Beyond mere financial support, chosen applicants will be able to benefit from expert guidance in creating a Target Development Profile (TDP) roadmap.
This roadmap will outline Regulatory and Access touchpoints during the product’s evolution.
Some of the highlights include:
- Quality management system aid
- Advice on system navigation
- Expedited clinical investigations
- Collaborative scientific advice with associated partners,
- Assistance with Health Technology Assessments (HTA) for product finalization and adoption
- Safe-harbour discussions about NHS adoption
- Exceptional use authorization granted by MHRA, contingent on meeting safety standards.
Applications for the IDAP pilot can be submitted through GovForms.
The form, which is segmented into seven parts, ranging from eligibility to submission, should be completed in a single session. Applications began on 25th September 2023 and will continue until 29th October 2023.
Data Protection and Privacy
The MHRA’s approach to handling personal data for the IDAP is intended to ensure the proper level of personal data protection.
While they do comply with data protection regulations, such as the UK GDPR and the Data Protection Act 2018, only specific partners will have access to personal data.
This information will be safeguarded on a secure digital platform, with any personal data being used solely to identify the applicant and to communicate about IDAP pilot activities.
Personal data will be stored for 15 years by the MHRA, after which it will be destroyed.
In summary, the IDAP pilot described in the guidance is a new initiative aimed at accelerating the development and deployment of innovative medical solutions in the UK.
By streamlining the regulatory process and offering expert guidance at every turn, it is expected to transform the landscape of healthcare technology in the country.
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