MHRA (Medicines and Healthcare Products Regulatory Agency) has published an update of the guidance for medical device software applications (apps). The guidance provides information on when software applications are considered to be medical devices and how these shall be regulated.
The guidance consists of an overall document and three appendices.
• Medical Device stand-alone software, including apps
– Appendix 1 – Symptom checkers
– Appendix 2 – Clinical Calculators
– Appendix 3 – ‘Drives or influences the use of a device’
The guidance is applicable to standalone software and apps placed on the Great Britain market. The guidance gives examples of software and apps which meet the definition of a medical device, and it outlines the requirements for UKCA-marking.
In UK, standalone software and apps that meet the definition of a medical device are required to be UKCA-marked in line with the Medical Device Regulation 2002, as amended (UK MDR 2002) in order to ensure they are safe to use and perform as intended. CE-marked devices will continue to be recognized in the Great Britain market until 30 June 2023. Please note that for Northern Ireland, different rules apply.
If you have any questions with regards to UKCA-marking of your medical device or other considerations with regards to classification of your software or regulatory requirements, don’t hesitate to send us an email at firstname.lastname@example.org