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 .




Kista All Stars

QAdvis participated in the event Kista All Stars in June, to connect and celebrate together with other amazing companies that all had achievements and awards to be proud of.

 A great possibility for inspiration and to meet others and network with our neighbors in Kista Science City, as well as getting inspired by fantastic people outside of the MedTech industry.

Read more here: Framtiden finns bland stjärnor i Kista – Kista Science City


QAdvis congratulate Combinostics Oy on their MDR certificate

QAdvis want to congratulate their customer, Combinostics Oy, for achieving their MDR certificate with help from our highly skilled consultants.
The transfer to MDR and/or IVDR is crucial for medical device manufacturers, to maintain market access in Europe.
We are proud that we can be part of that journey for several customers, guiding as well as providing hands-on work during both the implementation and certification process.

“QAdvis has been invaluable to Combinostics Oy in achieving this significant milestone. We are proud to be certified under MDR and look forward to enhancing the care of patients with neurodegenerative diseases through the use of our digital AI solutions”
Lennart Thurfjell, PhD, COO Combinostics Oy

Read more at Combinostics Oy website.