Are you putting your device forward for NICE assessment?
Does your test fall into specialised commissioning?
Have you identified all the local stakeholders?
Have you consulted the local stakeholders to design a local study that addresses local requirements?
Have you got a plan for continuing to engage with these stakeholders?
Has appropriate information and data been published in peer-reviewed journals?
Have you considered national / international data and privacy regulations?
Have you considered the likelihood of outcomes-based payments, implications for reimbursement rates based on Phase IV evidence?
Are the correct capabilities are in place for the collection and analysis of Real World Evidence if required?
Have you contacted the NIHR Clinical Research Network for free services and support tools?
Have you engaged early with MHRA through scientific advice meetings / the Innovation Office?
Have you gathered evidence to support PIMS criteria?
Have you gained positive PIM designation before applying for MHRA scientific review?
Have you engaged early with NICE, NHS England and devolved administrations?
Have you selected the most appropriate procedure for your product’s marketing authorisation application (centralised procedure or not)?
Have you ensured the appropriate data is included in the submission (end points, comparators, patient sub-group analysis etc.)?
Have you ensured that you can give rapid response to requests for additional data and clarifications?
Have you thought about beginning a national reimbursement process?
Have you ensured that enough evidence is available in line with NICE health technology assessments?
Is my app a medical device?
It probably is if it is for use in humans for the purpose of:
Have you ensured your product addresses the Caldicott principles?
Have you understood whether your product is classified as a medical device or diagnostic using MHRA guidance?