Medical Device Regulatory Update – October 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 European Commission has published MDCG 2020-16 Rev.5, updating the guidance on classification rules for in vitro diagnostic medical devices under the IVDR.

For IVD manufacturers, classification is a fundamental regulatory decision that can affect the conformity assessment route and regulatory strategy.

👉 MDCG 2020-16 Rev.5 – Guidance on Classification Rules for IVDs

🇬🇧 UK – The Door Opens to Direct MHRA Licensing

Proposed amendments to the UK Government's Health Bill could create powers supporting the future development of a medical device licensing regime.

The amendments also address information-sharing powers for medicines and medical devices and measures intended to make medicines and medical-device legislation easier to update.

This is an important development to watch for manufacturers planning access to the UK market.

👉 MHRA Regulatory Reform Amendments – Health Bill

🇬🇧 MHRA Warning – Incompatible Components Continue to Cause Serious Incidents