Medical Device Regulatory Update – October 2026

Medical Device made Easy Podcast · Oct 9, 2026

October brings another important round of regulatory developments for the medical device and IVD industry. From updated IVD classification guidance in Europe and potential changes to the UK medical device licensing framework, to new FDA expectations for robotically assisted surgical devices, radiology AI, PMA submissions, and international regulatory reliance, manufacturers have several developments worth following closely.

Here is our Medical Device Regulatory Update for October 2026, supported by regulatory intelligence from MedBoard.

European Union – Revised IVD Classification Guidance

The…