Call For Consultancy CE Marking

Invitation to Quote for Production of CE / UKCA Marking Documentation

The Digital Health & Care Innovation Centre (DHI) is seeking a supplier to support production of the documentation required for the technical files to enable CE / UKCA marking of two decision support products created as part of the national decision support programme

1. RESTORE2 to support assessment, triage and escalation in care home settings.  CE marking is required for the NEWS2 algorithm which underpins the RESTORE2 tool. The risk levels and outputs from this algorithm are tailored to the care home context.
2. A suite of reusable calculators and assessment tools which will be embedded in applications for use in care homes and primary care settings. The tools initially included in this suite are:

• 4-AT screening tool for delirium
• FeverPain and Centor for antibiotic prescribing for sore throat
• Asthma Control Questionnaire (ACQ-5) for assessing asthma control
• Risk Score for Asthma Exacerbation (RSE) for assessing risk of asthma exacerbation

All tools are classified as Class 1 devices under the Medical Devices Directive (MDD).  The aim is to submit self-assessments to the MHRA before May 2021 so that the tools can hold both the UK CA mark and the European CE mark.

Funding available

• £15,000 inclusive of VAT
• As a minimum, suppliers must be able to provide 23 days of work within this budget

Timeline

• All documentation must be delivered no later than 24th March 2021

All proposals must be submitted by 5 pm on 25 February 2021.

Read the full Call for Consultancy CE Marking Brief

Back

Share

• Facebook
• Twitter
• Linkedin
• Email
• Copy