UK Updates
UK’s AI Airlock Sandbox: Phase 2 Insights and What Comes Next
Date: June 2026
Artificial Intelligence is reshaping healthcare from diagnostics to patient monitoring but traditional medical device regulations were never designed AI systems. To bridge this gap, the MHRA launched the AI Airlock Sandbox, a safe environment where regulators and developers collaborate to test how AI medical devices fit within existing frameworks and identify where new guidance is needed.
Phase 2 (April 2025 – March 2026) expanded on the pilot, engaging seven candidate technologies across three critical regulatory challenge areas:
Key Insights
Recommendations
Impact and Next Steps
Phase 2 was independently evaluated and praised for fostering open regulatory dialogue. Stakeholders urged MHRA to translate sandbox insights into clearer, system level guidance.
Looking ahead:
Takeaway
The MHRA’s AI Airlock Sandbox demonstrates how collaborative, evidence based regulation can keep pace with disruptive technologies. For developers, the message is simple: AI innovation is welcome, but accountability and lifecycle safety are non negotiable.
Reference
https://www.gov.uk/government/publications/ai-airlock-sandbox-phase-2-programme-report
MHRA Innovation Accelerator: Fast Tracking Safe AI and MedTech in the UK
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has launched the Innovation Accelerator, a flagship programme designed to help innovators bring cutting edge medical technologies especially for AI enabled solutions to patients.
This initiative builds on the success of the AI Airlock Sandbox, reflecting the UK Government’s ambition to make the NHS the most AI enabled healthcare system in the world.
What the Innovation Accelerator Offers
Importance
Medical device innovators often face barriers such as:
The Innovation Accelerator provides a structured environment to address these issues, ensuring that promising technologies can move from concept to clinic without unnecessary delays.
Implications for Industry
Conclusion
The MHRA Innovation Accelerator signals a new era of collaborative regulation in the UK. By combining sandbox experimentation with structured acceleration, the MHRA is positioning the UK as a global leader in safe, evidence based AI adoption in healthcare.
To read more visit : https://www.gov.uk/government/publications/mhra-innovation-accelerator
European Updates
eIFU in the EU: A New Era for Medical Device Documentation
On 25 June 2025, the European Commission announced a landmark regulation that reshapes how medical device manufacturers provide instructions for use (IFU). For the first time, all medical devices used by healthcare professionals in the EU can now be accompanied by electronic IFUs (e IFU).
Benefits of e-IFU for Manufacturers and Healthcare Systems
Challenges and Risks in e-IFU Implementation
Strategic takeaway:
The adoption of Regulation (EU) 2025/1234 marks a decisive step toward digitalisation, sustainability, and efficiency in medical device regulation. By allowing e IFUs for all professional use devices, the EU empowers manufacturers to modernise compliance while supporting healthcare systems in delivering safer, more efficient care.
With enforcement set for July 2026, manufacturers must act now, updating SOPs, validating systems, training teams, and preparing for audit readiness.
Read the full blog with detailed insights, practical steps and global comparisons on the Sushvin Consultancy Website.
#MedTech #RegulatoryAffairs #eIFU #MedicalDevices #Innovation #Sustainability #EURegulation
EU Update: New Harmonised Standard for Medical Device Symbols
Date: June 2026
On 15 June 2026, the European Commission adopted Implementing Decision (EU) 2026/1313, amending the earlier Decision (EU) 2021/1195. This update directly impacts medical device manufacturers by revising the harmonised standard EN ISO 15223 1:2021, which is the cornerstone for symbols used in medical device labelling and information supplied by manufacturers.
Changes
The amendment presents EN ISO 15223 1:2021/A1:2025, which includes:
This change reflects the EU’s effort to simplify and standardise labelling across authorities.
Transition Timeline
Compliance Implications
Takeaway
This amendment is a strategic regulatory update: it modernises labelling requirements, reduces duplication, and ensures consistency across EU and global markets. Manufacturers should start planning labelling updates now, even though the transition period runs until 2031.
MDCG Position Paper: Managing SS(C)Ps in EUDAMED after mandatory use
The European medical device regulation continues to change. A recent MDCG Position Paper (MDCG 2026-4) clarifies how Summaries of Safety and Clinical Performance (SSCPs) and Summaries of Safety and Performance (SSPs) will be managed in the EUDAMED.
Current Situation
The summary of safety and clinical performance and the summary of safety and performance (SSCP and SSP respectively) are uploaded by the notified body during the process of registering certificates information according to Article 32(1) MDR and Article 29(1) IVDR.
Key Change
Revision of the guidance MDCG 2019-9 – rev.1 on SSCP:
The revised guidance (MDCG 2019-9 rev.1) assigns manufacturers the responsibility to upload both the master SSCP and its translations. Notified bodies will continue to validate SSCPs and indicate the validated versions by linking them to the relevant Basic UDI-DIs.
Timeline
During (May–October 2026), notified bodies will continue to upload master SS(C)Ps without translations. Manufacturers need to manage translations in line with MDCG 2021-1 rev.1 and MDCG 2022-12.
Implications for Manufacturers
Manufacturers must:
Conclusion
The MDCG’s position highlights a broader regulatory trend. This shift is a significant transition of responsibility from notified bodies to manufacturers, for accountability and transparency in device safety communication.
By October 2026, manufacturers will be expected to take full ownership of SS(C)P uploads, ensuring consistency, accuracy, and accessibility across the EU market.
EU Expands Exemptions for Well Established Medical Devices under MDR
Date: July 2026
The European Commission has adopted two important delegated regulations amending the Medical Device Regulation (EU) 2017/745 (MDR). These updates expand the list of class IIb implantable devices and class III devices that are exempted from certain conformity assessment and clinical investigation obligations.
The changes reflect the recognition of some long established technologies with stable designs, well documented safety and consistent clinical performance do not require the same level of repeated scrutiny as newer, less established devices.
Regulation (EU) 2026/1359 – Class IIb Implantable Devices
These devices are considered well established technologies with a long history of safe use in the EU market.
Regulation (EU) 2026/1451 – Class III & Implantable Devices
Manufacturers of these devices are still required to conduct a clinical evaluation based on sufficient existing data, but not new clinical investigations.
Importance
Implications for Industry
Final thought
The EU’s June 2026 delegated regulations mark a realistic evolution of MDR balancing patient safety with regulatory efficiency. By exempting well established implantable and class III devices from repetitive assessments, the Commission is signalling confidence in proven technologies while freeing capacity to oversee emerging innovations.
To read more visit : https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202601359
USA Updates
FDA Clinical Decision Support Software Frequently Asked Questions (FAQs)
Date: June 2026
Clinical Decision Support (CDS) tools are increasingly embedded in healthcare from simple calculators to advanced AI driven platforms.
They help clinicians interpret data, guide treatment choices, and improve patient outcomes. But not all CDS software is regulated as a medical device, and distinguishing between regulated and non regulated functions has been a persistent challenge.
FDA’s Guidance
The FDA’s updated CDS Guidance provides clarity on:
Key FAQs
The FDA’s FAQs address common scenarios:
Digital Health Policy Navigator
To help developers, FDA offers the Digital Health Policy Navigator. It is a seven step tool guiding sponsors through relevant policies. It links product features to regulatory considerations, ensuring developers can map each software function against FDA oversight criteria.
Implications
Takeaway
The FDA’s June 2026 update highlights a critical point that not all CDS is exempt, and intended purpose matters. Developers must evaluate each function carefully, using the CDS Guidance and Digital Health Policy Navigator to ensure compliance.
By clarifying boundaries, FDA aims to support innovation while safeguarding patient safety in an era where software increasingly drives clinical decision making.
Australia Updates
Understanding Australia’s Unique Device Identification (UDI) System
The Australian Government, through the Therapeutic Goods Administration (TGA), has introduced the Unique Device Identification (UDI) for medical devices.
What is UDI?
The Unique Device Identification (UDI) system is a standardized method designed to uniquely identify medical devices throughout their lifecycle. UDI enables faster identification of medical devices during critical situations such as adverse events, safety alerts, or recalls.
UDI assigns a unique identifier to every medical device model. This identifier consists of two key components:
Australian UDI Database (AusUDID)
A key component of the UDI ecosystem is the Australian UDI Database (AusUDID). This centralized repository stores device identifiers and related product information, making it accessible to:
AusUDID stores only device information submitted by sponsors and manufacturers, no patient data are collected or stored.
Key Benefits of UDI Implementation
Enhanced Patient Safety
UDI allows precise identification of devices used in patients, especially implants. This is crucial when managing recalls or addressing safety concerns.
Faster Response to Safety Issues
With accurate device tracking, healthcare providers can quickly identify and isolate affected devices, minimizing potential harm.
Improved Data and Research
UDI supports better data collection for regulatory bodies and researchers, enabling more effective performance evaluation and comparative studies.
Global Harmonization
Australia’s adoption aligns with international standards, promoting consistency in device identification worldwide.
Implementation Timeline:
The rollout of UDI in Australia is being implemented gradually over a five-year period, allowing manufacturers and sponsors time to adapt:
Preparing for UDI Compliance
Conclusion
The introduction of UDI in Australia, through the Therapeutic Goods Administration (TGA) marks a significant step toward safer, more transparent healthcare. By improving traceability, supporting research, and strengthening post market surveillance, UDI enhances both patient safety and regulatory confidence.
For guidance visit https://lnkd.in/ghhvbEec
ISO Updates
ISO Update 1 May to 1 June 2026: Key Developments in Medical Device Standards
The June 2026 ISO Update highlights several important Committee Drafts (CDs) and DIS that will shape the future of medical devices, dentistry, and healthcare organization management.
Implants for Surgery
ISO/CD 24085-1Partial and total shoulder joint replacement — Part 1: Determination of resistance to torque of head fixation of modular humeral components
Biological Evaluation of Medical Devices
ISO/CD 8250 – Characterization of residuals relevant to the biological evaluation of medical devices
Biological & Clinical Evaluation
Dentistry
Cleanrooms and associated controlled environments
In vitro diagnostic medical devices
Sushvin Provides UK Responsible Person (UK RP) Services
Are you a legal medical device/IVD manufacturer located outside the UK and would like to market your product in the UK, then you will require a UK responsible person who will act on behalf of the manufacturer to ensure all the responsibilities detailed within the updated UK MDR 2002 regulations are met.
As a legal manufacturer, organisations will have to register their devices prior to be placed on the UK market.
If you need UK Responsible Person (UK RP) services, please contact SUSHVIN for more information.
If you are planning to market your product in the EU and if you require PRRC (Person Responsible for Regulatory Compliance), we have a team of experienced regulatory professionals who can help you assist with PRRC services and get you regulatory compliant as per MDR 2017/745 and IVDR 2017/746
If you need PRRC Services, please contact SUSHVIN for more information.
