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
The MHRA has highlighted ongoing safety concerns involving patient hoists and incompatible components.
The warning is an important reminder that medical-device safety does not stop with individual component compliance. Compatibility between components, accessories and systems can directly affect patient safety.
Manufacturers and healthcare organizations should pay close attention to compatibility information, instructions for use and the way devices are combined in real-world environments.
👉 MHRA – Steps to Prevent Avoidable Harm from Patient Hoists
🇨🇭 swissdamed – Importer Linking Is Now Operational
Another important development comes from Switzerland.
Swiss importers can now link their CHRN to imported devices in swissdamed.
This adds another operational consideration for manufacturers and importers working in the Swiss medical-device market, particularly as swissdamed becomes increasingly important within the country's regulatory infrastructure.
👉 Swissmedic – Information for Importers in swissdamed
🌍 Rest of the World
🇺🇸 FDA – Robotically Assisted Surgical Devices
The FDA has issued draft guidance addressing robotically assisted surgical devices.
The guidance covers areas including non-clinical testing, clinical evidence and labeling for teleoperated surgical systems.
For manufacturers developing robotic surgical technologies, understanding these expectations early can help inform development, testing and premarket strategy.
👉 FDA – Robotically Assisted Surgical Devices: Premarket Submissions
🤖 FDA Rejects Proposed 510(k) Exemption for Radiology AI Devices
AI remains firmly on the regulatory agenda.
The FDA has rejected a proposed exemption from premarket notification for certain radiology computer-aided detection, diagnosis and triage devices.
The practical message for manufacturers is clear: these products must continue to obtain the applicable FDA clearance before being marketed.
👉 FDA – Radiology Computer-Aided Detection, Diagnosis and Triage Devices
🇺🇸 FDA Moves PMA Applications Toward Structured Electronic Submissions
The FDA is also moving toward a more structured approach to electronic Premarket Approval (PMA) applications.
Draft guidance introduces electronic resources and templates intended to improve submission consistency and review efficiency.
Manufacturers working on PMA submissions should follow this development as electronic submission structures continue to evolve.
👉 FDA – Electronic Submission Template for PMA Applications
🌐 FDA Creates a Regulatory Reliance Resource Centre
International regulatory reliance continues to gain attention.
The FDA has created a dedicated CDRH Regulatory Reliance Portal explaining how other regulatory authorities can leverage FDA regulatory work and decisions while retaining their own national sovereignty and decision-making responsibilities.
For an increasingly global medical-device industry, regulatory reliance could play an important role in reducing unnecessary duplication and supporting more efficient regulatory processes.
👉 FDA CDRH Regulatory Reliance Portal
🛠️ What's New at Easy Medical Device?
Alongside this month's regulatory developments, Easy Medical Device continues to expand the resources and services available to medical-device companies.
EasyIFU
EasyIFU supports medical-device manufacturers working with electronic Instructions for Use.
👉 Discover EasyIFU
New Partner Services
New partner services are also available in areas including:
Software Development & Cybersecurity
Company Creation
These services expand the support available to medical-device companies across different stages of their development and market-access journey.
🎙️ Latest Easy Medical Device Podcast Episodes
October is also a good opportunity to catch up on the latest Medical Device Made Easy episodes.
Episode 406 – Your Technical Documentation Has All the Documents… So Why Isn't It Ready?
Having every document does not necessarily mean your Technical Documentation is assessment-ready. This episode explores adequacy, consistency, evidence and traceability across the dossier.
👉 Listen to Episode 406
Episode 407 – Why Management Doesn't Listen to Quality and How to Change That
Why do Quality and Regulatory teams sometimes become isolated from the rest of the organization? This episode explores the shift from being the “Quality Police” to becoming a Quality Influencer.
👉 Listen to Episode 407
Episode 408 – Vertical Slicing for Complex SaMD Development
Complex SaMD development can become fragmented when teams focus on individual components. This conversation explores vertical slicing as a way to look at functionality and clinical workflows end-to-end.
👉 Listen to Episode 408
Episode 409 – AI Is Already Inside Your QMS – But Is It Under Control?
AI may already be used by Quality, Regulatory, Engineering and PMS teams—even without a formal company-wide AI initiative.
This episode discusses Shadow AI, risk-based AI control, verification, human accountability and how Quality teams can approach AI without simply banning it.
👉 Listen to Episode 409
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