literature review

Phase 2 - Authorisation phase


The Authorisation phase covers development steps required to place a digital therapy on the UK market (including NHS adoption) as medical device. Any app labelled as ‘therapy’ automatically falls under the legal definition of a medical device; as does any app with any other intended medical purpose which includes prevention, diagnosis, monitoring, treatment, or alleviation of a disease.

Developers of all medical devices are required to use a Quality Management System. Required steps in the Authorisation phase include an evidence-based intended purpose statement of the medical device, as well as an associated risk classification. For most digital therapies, this is currently Class I (low risk), but will soon increase to Class IIa (medium risk) in-line with EU definitions.

Conformity with applicable standards for Class I devices (as specified in the UK Medical Devices Regulation [MDR] 2002) can be self-declared. All other device classes (including IIa) require certification by an UK-based Approved Body. Declaration of conformity allows the placement of a UK Conformity Assesses (UKCA) logo on the device, which allows marketing in the UK, after registration with the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).

Required outputs of the Authorisation phase
  • A clear and concise, evidence-based intended purpose statement of the digital therapy, which must specify
    • what the product does (the effect),
    • its indication for use (the clinical condition it is designed to benefit and the target population),
    • who it should be used by (for example people with the intended clinical condition or healthcare professionals),
    • and where it should be used (for example. in NHS services or at-home).
  • Intended purpose statements must have a documented evidence-base, generally in the form of a clinical evaluation report which summarises existing clinical evidence and technical device documentation. Some devices may require the creation of evidence through clinical investigations , which are subject to additional approval processes by MHRA (see tips and resources) .
  • Related to creating the intended purpose statement of a digital therapy with the corresponding evidence base is the risk classification of the medical device. Most digital therapies in the UK are
  • UKCA marking for medical devices requires the preparation of a technical file and other documentation to support the intended declaration of conformity. This file must:
  • Once a device has received a UKCA mark, it must be registered with MHRA before it can be placed on the market (which includes NHS adoption). Registration requires supply of manufacturer and device details and is subject to a statutory fee (currently £240).

Tips and Resources

A Quality Management System (QMS) must be used to record scope specification, policies, processes, design controls, technical documentation, risk management records, manufacturing and supply chain documentation, post-marketing surveillance and vigilance, training, personnel, and audit and review records. For Class IIa devices the QMS should be certified as compliant with ISO 13485 and this is also recommended for Class I devices. 

The Clinical Evaluation Report is generally stored separately in QMS-linked technical documentation. To save time and effort in the later Evaluation and Guidance phase of the MedTech pathway, it is advisable to use the NICE Single Technology Appraisal (STA) template. The supporting documents for the template, including a user guide, are available to document evidence of clinical effectiveness and safety evidence (sections 2). An example of a successfully completed NICE STA resulting in NICE recommendation for NHS adoption [MTG70] of a digital therapy addressing insomnia in adults using a self-help sleep improvement programme based on cognitive behavioural therapy can be accessed in Section 5a (Company evidence submission [Part 1 clinical]) of the supporting documentation

To help developers create an appropriate evidence base for their product, the National Institute for health and Care Excellence (NICE) has produced an Evidence Standards Framework (EFS) for digital health technologies; and the NHS England’s Transformation Directorate has published its Digital Technology Assessment Criteria (DTAC) for health and Social Care.

MHRA has provided If a digital therapy is intended for implementation on a health IT system (i.e. provides information for health and/or social care purposes), then its manufacturer additionally need to comply with the national clinical safety and risk management standard DCB0129. This standard requires the appointment of a Clinical Safety Officer (CSO), who must be currently registered with the General Medical Council (GMC) or the Nursing and Midwifery Council (NMC). CSOs can act as UK Responsible Person for MHRA purposes.

 

 

 

 

 

 

 

 

 

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