Development Pathway

Development

Further refinement of the product is carried out, as well as evidence gathering for any regulations that will apply. Clinical effectiveness and business case data should also be considered at this stage.

Considerations

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In the EU, clinical evaluation (assessment of clinical data) is required to demonstrate that a medical or diagnostic device is safe and performs as intended. Manufacturers / developers of medical and diagnostic devices must demonstrate that they conform to the requirements outlined in the relevant European Directive before the product can be freely marketed in Europe

Relevance:Devices and Diagnostics

The clinical evaluation requirement depends on the device class and/or evidence available. For low-to-medium risk devices (Class I, Class IIa and IIb) a literature review and/or clinical evaluation can be sufficient whereas high risk devices (Class III) may require clinical investigation

Relevance:Devices and Diagnostics

The CE mark is a key indicator of a product’s compliance with EU legislation. The requirements and assessment process varies by class of device and diagnostic. For more information see guidance by the MHRA

Relevance:Devices and DiagnosticsDigital

Best practice is to prepare a technical file/design dossier to record evidence of your conformity with EU requirements (for both self-assessment or to be used as part of an assessment by a Notified Body)

Relevance:Devices and DiagnosticsDigital

Class I medical devices, where these have been assessed for conformation to EU standards you, or your authorised representative, must register with the competent authority in the EU state where you have an office or place of business. In the UK, the MHRA is the competent authority. For Class IIa and above, a notified body will assess your conformation with EU standards (no additional registration with a competent authority is required)

Relevance:Devices and Diagnostics

For diagnostics, there are a number of ways you can demonstrate conformity with the IVD Directive, which involve a choice of testing and quality assurance modules; the choices depend on the classification of the device

Relevance:Devices and Diagnostics

Further clinical and cost-effectiveness evidence may need to be gathered later in the development pathway to support the value proposition of the product

Relevance:Devices and DiagnosticsDigital

Consider alerting NIHR Horizon Scanning Research Intelligence Centre about your product’s development

Relevance:PharmaceuticalDevices and DiagnosticsDigital

Consider the route to reimbursement and finalise the price of the device for cost-effectiveness and pricing discussions

Relevance:PharmaceuticalDevices and DiagnosticsDigital

Phase III trials are only for medicines that have passed Phases I and II. Phase III trials involve giving a medicine to large groups of people (up to thousands) to collect information on its effectiveness, compare the drug to comparator treatments and monitor side effects. They often last a year or more, and these trials may test new treatments, new dosage levels or new methods of action

Relevance:Pharmaceutical

Once Phase III studies have been completed, all available evidence is compiled for the regulatory dossier

Relevance:Pharmaceutical

Cost effectiveness analyses are often carried out alongside clinical trials with comparators that reflect current practice; the UK has a number of expert organisations that can support this process

Relevance:Pharmaceutical

It is best practice for digital health technologies to develop clinical evidence around their safety and efficacy; you may want to consider the type of evidence you are collecting based on whether the technology is for prevention or intervention, and whether it will be bought be clinicians or patients


Relevance:Digital

EU legislation requires all claims around health and wellbeing to be supported by evidence

Relevance:PharmaceuticalDevices and DiagnosticsDigital

Clinical evaluation (assessment of clinical data) is required to demonstrate that digital health technologies are safe and perform as intended.

Relevance:Digital

Some digital health technologies may be classed as medical devices. 
The clinical evaluation requirement depends on the device class and/or evidence available. For low-to-medium risk devices (Class I, Class IIa and IIb) a literature review and/or clinical evaluation can be sufficient whereas high risk devices (Class III) may require clinical investigation

Relevance:Digital
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