Clinical Decision Support Guidance Suggests FDA Will Regulate Risk Scores, Treatment Recommendations
Though nonbinding, the recent guidance provides clues on which types of clinical decision support software the FDA will treat like medical devices.
UK Regulator Publishes Response to Public Consultation on New IVD Regulations
The response is part of an ongoing process by UK regulators to implement new regulations covering medical devices and IVDs following the UK's 2020 exit from the EU.
Europe is still struggling to meet the requirements of the regulation, which calls for the clearance of most tests by notified bodies before they can be sold for clinical use.
New Guidance Related to IVDR Issued Covering High Risk IVDs
The guidance lays out guidelines on how notified bodies should carry out batch testing of manufacturers' Class D devices as part of conformity assessment.
The year saw the resolution of pressing issues around how IVDs will be regulated in Europe, including the UK, in the future.