Update of the guidance for medical device software applications (apps)

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 ukrp@qadvis.com

LINK; Medical devices: software applications (apps)

Book of the Year Award

Fantastic news!

Regulatory Affairs Professional Society (RAPS) has congratulated Robert Ginsberg and Mikael Dahlke for their efforts in co-writing Software as a Medical Device as a “publication that is well-written, accurate, relevant, and presents new information that fills a gap in regulatory knowledge on an emerging, cutting-edge, or state-of-the-art topic.” It was selected for the RAPS Book of the Year Award. Robert and Mikael have written the chapter related to: Safety risk management of software.

Congratulations, and thank you Robert and Mikael and the other leading software expert colleagues for your thought leadership and for your commitment to the profession! Your effort to simplify the regulatory complexity for the industry is well appreciated.

The book can be purchased from RAPS, and Robert and Mikael can be reached at www.qadvis.com and info@qadvis.com .