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Health Institution Exempt Medical Devices

Our research, development and innovation work extends into products and solutions that have a direct impact on healthcare, and so qualify as Medical Devices.

One example of this is the Optimised Surgery Care and Assessment Record (OSCAR) decision support tool for pre-op assessments, which is described at the bottom of the RD&I page.  Since OSCAR is used exclusively within the Royal Liverpool University Hospitals NHS Foundation Trust, it is subject to a subset of the Medical Device Regulations 2017/745 known as the Health Institution Exemption.

Below is our public declaration that OSCAR is compliant with the applicable parts of the Medical Device Regulations 2017/745.

Health Institution Exemption Declaration

CD1906/01 Page 2 (September 2020)