Developers of health apps such as clinical calculators and symptom checkers will face stricter regulatory oversight as the MHRA expands the range of apps falling under the medical devices regulations.
Introduced in June, the new MHRA Apps Guidance is likely to force developers to re-assess regulatory status and classification of their products under the medical devices regulations, as the line between medicine and wellness becomes increasingly difficult to tread.
Justyna discusses what developers need to know in the full article first published by Digital Health News, 18 August 2020.
