Evaluation Pathway

Evaluation

This is the "real world" testing of your product, at either a national or regional level depending on the evidence required. Patient impact and cost-effectiveness evidence is prepared for the business case development.

Questions

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Are you putting your device forward for NICE assessment?

Relevance:Devices and Diagnostics

Does your test fall into specialised commissioning?

Relevance:Devices and Diagnostics

Have you identified all the local stakeholders?

Relevance:PharmaceuticalDevices and DiagnosticsDigital

Have you consulted the local stakeholders to design a local study that addresses local requirements?

Relevance:PharmaceuticalDevices and DiagnosticsDigital

Have you got a plan for continuing to engage with these stakeholders?

Relevance:PharmaceuticalDevices and DiagnosticsDigital

Has appropriate information and data been published in peer-reviewed journals?

Relevance:PharmaceuticalDevices and DiagnosticsDigital

Have you considered national / international data and privacy regulations?

Relevance:Digital

Have you considered the likelihood of outcomes-based payments, implications for reimbursement rates based on Phase IV evidence?

Relevance:Pharmaceutical

Are the correct capabilities are in place for the collection and analysis of Real World Evidence if required?

Relevance:PharmaceuticalDevices and DiagnosticsDigital

Have you contacted the NIHR Clinical Research Network for free services and support tools?

Relevance:PharmaceuticalDevices and DiagnosticsDigital

Have you engaged early with MHRA through scientific advice meetings / the Innovation Office?

Relevance:PharmaceuticalDevices and Diagnostics

Have you gathered evidence to support PIMS criteria?

Relevance:Pharmaceutical

Have you gained positive PIM designation before applying for MHRA scientific review?

Relevance:Pharmaceutical

Have you engaged early with NICE, NHS England and devolved administrations?

Relevance:PharmaceuticalDevices and Diagnostics

Have you selected the most appropriate procedure for your product’s marketing authorisation application (centralised procedure or not)?

Relevance:Pharmaceutical

Have you ensured the appropriate data is included in the submission (end points, comparators, patient sub-group analysis etc.)?

Relevance:Pharmaceutical

Have you ensured that you can give rapid response to requests for additional data and clarifications?

Relevance:Pharmaceutical

Have you thought about beginning a national reimbursement process?

Relevance:Pharmaceutical

Have you ensured that enough evidence is available in line with NICE health technology assessments?

Relevance:PharmaceuticalDevices and Diagnostics

Is my app a medical device?
It probably is if it is for use in humans for the purpose of:

  • The diagnosis, prevention, monitoring, treatment or alleviation of disease
  • The diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap
  • The investigation, replacement or modification of the anatomy or of a physiological process
Relevance:Digital

Have you ensured your product addresses the Caldicott principles?

Relevance:Digital

Have you understood whether your product is classified as a medical device or diagnostic using MHRA guidance?

Relevance:Digital
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