UK Updates
UK's Indefinite Recognition of CE-Marked Medical Devices
The UK Government on 21 October 2026 has announced that CE-marked medical devices and IVDs will continue to be recognized indefinitely in Great Britain. This provides the long-term regulatory certainty for manufacturers. This announcement will ensure continued access to essential healthcare technologies for patient.
Public consultation
This decision follows a public consultation which ran from 16 February 2026 to 10 April 2026 and confirms that products already approved under the EU regulatory framework can continue to access the Great Britain market without requiring an additional approval route. Since more than 90% of devices currently registered in Great Britain carry a CE mark, this announcement makes a significant development for the MedTech sector.
Patient Safety
The MHRA will continue to monitor devices placed on the UK market through post-market surveillance, vigilance reporting, and international safety cooperation. Recognition of CE-marked devices does not reduce manufacturers' obligations to maintain compliance and monitor product performance.
Key compliance considerations for manufacturers
Manufacturers should note that while CE-marked devices will continue to be accepted in Great Britain, compliance with MHRA registration requirements, UK Responsible Person (UKRP) obligations, and post-market surveillance responsibilities remains essential for maintaining market access and regulatory compliance.
Conclusion
The UK's decision to indefinitely recognize CE-marked medical devices is a realistic move that supports regulatory stability, reduces compliance burden, and ensures continued access to medical devices and technologies.
To read more visit https://lnkd.in/eWPbNFTn
UK's New Vision for AI in Healthcare:
The UK Government has taken a significant step toward shaping the future of AI-enabled healthcare by accepting all 44 recommendations made by the National Commission into the Regulation of AI in Healthcare. The Government's response outlines a comprehensive roadmap to modernise the regulatory framework, strengthen public trust, enhance patient safety, and accelerate the responsible adoption of AI across the healthcare system.
Importance
Artificial Intelligence is already demonstrating value in healthcare by supporting earlier diagnosis, improving clinical decision-making, automating repetitive tasks, and reducing administrative burdens. The UK Government highlighted that existing regulations were developed before today's AI technologies emerged and are therefore no longer fully fit for purpose.
The Government's vision is clear:
Three Pillars of the Future AI Regulatory Framework
The Government's action plan is built around three key principles.
1. Proportionate Lifecycle Regulation
The MHRA plans to move away from traditional static regulatory oversight toward a lifecycle-based approach that recognizes the dynamic nature of AI technologies.
Key initiatives include:
2. System-Wide Responsibility for Safe AI Adoption
The report emphasises that safe AI deployment is not solely the responsibility of manufacturers. Healthcare providers, clinicians, regulators, policymakers, and procurement teams all have essential roles to play.
The Government plans to:
This systems-based approach acknowledges that AI performance depends not only on the technology itself but also on the environment in which it operates.
3. Trust, Transparency and Predictability
Trust remains one of the most important barriers to AI adoption in healthcare.
To address this, the Government intends to:
The framework aims to create greater confidence among patients, clinicians, healthcare providers, and developers alike.
Implication for manufacturers
Several proposals could directly impact medical device manufacturers.
Predetermined Change Control Plans (PCCPs)
The MHRA intends to publish draft guidance on PCCPs by December 2026, allowing manufacturers to define acceptable boundaries for future modifications without requiring complete reassessment for every update.
Enhanced Post-Market Surveillance
Manufacturers should expect stronger requirements for:
The future regulatory model places significant emphasis on continuous assurance rather than one-time approval.
Transparency of General-Purpose AI Models
The MHRA plans to explore "Master Files" for foundation models and require manufacturers to disclose dependencies on underlying AI models, associated risks, and mitigation strategies.
This reflects growing global regulatory concerns around large language models and foundation AI technologies integrated into healthcare products.
Cybersecurity Expectations
The MHRA will issue dedicated cybersecurity guidance and educational resources, reinforcing cybersecurity as a patient safety issue rather than merely an IT concern
Key Timelines
Several important milestones have already been announced:
| Timeline | Activity |
|---|---|
| December 2026 | Draft PCCP guidance expected |
| Spring 2027 | Consultation on AI device classification and qualification |
| Spring 2027 | Guidance on AI regulation, transparency, post-market surveillance, cybersecurity, and AI readiness initiatives |
| Spring 2027 | Delivery roadmap and implementation plan publication |
| Ongoing | Development of lifecycle-based regulation and international harmonisation initiatives |
All 44 recommendations have been accepted, signalling strong governmental commitment to execution rather than further consultation alone.
Implications for the Medical Device Industry
Manufacturers developing AI-enabled medical devices should begin preparing now for heightened expectations around change management, post-market surveillance, cybersecurity, transparency, and performance monitoring.
Conclusion
The UK Government's response to the National Commission on AI in Healthcare represents one of the most comprehensive AI-healthcare regulatory initiatives globally. By accepting all 44 recommendations, the MHRA and its partners have signalled a move toward a more agile, proportionate, and lifecycle-based regulatory system that seeks to balance innovation with patient safety.
Reference
European Updates
The Future of European Standardisation
Published October 2026
The European Commission has proposed a new regulation on European Standardisation, replacing regulation (EU) No 1025/2012.
The proposal introduces measures to accelerate standard development by setting clearer timelines, enhancing monitoring, and creating fallback mechanisms. Where traditional European Standardisation Organisations (CEN, CENELEC, and ETSI) are unable to deliver standards in a timely manner, the Commission may request standards from designated alternative Standards Development Organisations (SDOs).
For manufacturers, notified bodies, regulatory professionals, and technology innovators, this proposal could significantly reshape how standards are developed and used to demonstrate compliance with EU legislation.
Key highlights:
Implications for the medical device industry
For medical device manufacturers and regulatory professionals, the proposal carries potentially significant implications.
Quicker support for new regulations
Medical device regulations often depend on harmonised standards to clarify compliance pathways. Faster standard development could reduce uncertainty associated with the implementation of evolving regulatory requirements.
Improved SME participation
Many innovative medical technology companies are SMEs. Enhanced participation mechanisms could allow smaller manufacturers to influence future standards more effectively and ensure that standards remain practical and innovation-friendly.
Better alignment with emerging technologies
The increasing integration of:
requires agile standardisation processes. The proposed framework may help address long-standing delays in developing standards supporting these technologies.
Conclusion
The European Commission's proposed regulation on European Standardisation is more than a legislative update. It represents a strategic effort to modernise one of the fundamental pillars of the EU regulatory ecosystem.
By addressing delays, broadening participation, reinforcing global influence, and creating a more resilient framework, the proposal seeks to ensure that European standardisation remains fit for an era defined by digital transformation, sustainability, and technological competition.
For the medical device industry and other highly regulated sectors, the outcome of this legislative process could significantly influence future compliance strategies, innovation pathways, and market access across Europe.
MDCG 2026-4 rev.1
The publication of MDCG 2026-4 rev.1 marks a significant step in the European Commission's ongoing EUDAMED implementation journey. The position paper introduces a significant change in the way Summary of Safety and Clinical Performance (SSCP) and Summary of Safety and Performance (SSP) documents will be managed following the mandatory use of EUDAMED modules.
The Current Process
Presently SSCPs for MDR devices and SSPs for IVDR devices are uploaded by notified bodies during certificate registration activities, in accordance with Article 32(1) MDR and Article 29(1) IVDR.
The Key Change
According to the position paper, the ongoing revision of MDCG 2019-9 rev.1 will transfer responsibility for uploading SS(C)Ps within EUDAMED from notified bodies to manufacturers.
Transition Timeline
From 28 May 2026, the mandatory use date for the first four EUDAMED modules, and until the new SS(C)P management functionality becomes available, notified bodies will continue uploading the master SS(C)P or SSP when registering new certificates or certificate updates. During this phase, translations are not required to be uploaded by notified bodies.
Manufacturers will continue to manage translations according to existing MDCG guidance.
EUDAMED Roadmap
Conclusion
MDCG 2026-4 rev.1 represents more than a technical update to EUDAMED. It reflects the European Commission's broader objective of placing greater responsibility on manufacturers for maintaining accurate, transparent, and publicly accessible safety and performance information.
Reference
New revision of the MDCG Position Paper on the management of SS(C)P in Eudamed after mandatory use
USA Updates
FDA eSTAR: The Future of Medical Device Submissions
The medical device regulatory landscape is moving toward greater efficiency, transparency, and digitalization. One of the most significant initiatives supporting this transformation is the FDA's electronic Submission Template and Resource (eSTAR).This is a structured electronic submission platform designed to modernize medical device premarket submissions and improve submission quality.
Mandatory Use of eSTAR
What is eSTAR?
The FDA's electronic Submission Template and Resource (eSTAR) is an interactive PDF-based submission tool that guides manufacturers through the preparation of medical device submissions. It provides a standardized format and helps applicants organize information in a consistent manner while ensuring that critical regulatory requirements are addressed.
The primary objective of eSTAR is to enhance submission quality by helping manufacturers prepare complete and comprehensive regulatory dossiers, ultimately supporting more efficient FDA reviews.
Importance of eSTAR
Preparing a regulatory submission can be a complex and time and resource-intensive process. Incomplete submissions, missing documentation, and inconsistent presentation of information can result in additional information requests and review delays.
eSTAR addresses these challenges by:
Application for Medical Device Manufacturers
Manufacturer planning FDA submissions should be familiar with eSTAR requirements and submission format. Even if a manufacturer's current products are not expected to follow the Premarket Approval (PMA) pathway, the continued expansion of eSTAR demonstrates the growing importance of digital and structured regulatory submission processes.
Conclusion
The FDA's electronic Submission Template and Resource (eSTAR) is playing an increasingly important role in modern medical device regulation. By providing a standardized and structured framework for premarket submissions, eSTAR helps improve submission quality, supports efficient FDA reviews, and contributes to faster access to safe and effective medical devices.
Reference
eSTAR Program
Australia Updates
Australia’s CDSS Regulation: Innovation with Accountability
As Clinical Decision Support Software (CDSS) becomes increasingly embedded in healthcare, regulators are working to ensure that innovation does not compromise patient safety. Australia's Therapeutic Goods Administration (TGA) has introduced a clear framework that distinguishes between software that merely supports clinical decisions and software that actively drives diagnosis or treatment. This distinction has significant implications for digital health and AI developers.
Importance
Not all CDSS solutions are regulated in the same way. Depending on their functionality, software may be:
This classification directly impacts market access, compliance obligations, and regulatory strategy.
The Key Question: Support or Replace?
The TGA's approach: Does the software support a clinician's decision, or does it replace clinical judgment?
To qualify for exemption, CDSS must:
On the other hand, software that autonomously diagnoses conditions, recommends treatments without transparency, or analyzes medical images and physiological signals typically falls under stricter regulatory oversight.
Transparency Is the New Regulatory Currency
A standout feature of the guidance is its emphasis on explainability. The TGA clearly favours "glass-box" systems, where clinicians can understand how recommendations are generated, over "black-box" algorithms that provide outputs without visible reasoning.
For AI developers, this sends a strong message: sophisticated algorithms alone are not enough. Regulatory acceptance increasingly depends on transparency, traceability, and clinician oversight.
Exempt Doesn't Mean Unregulated
Even when CDSS qualifies for exemption from ARTG inclusion, regulatory responsibilities remain. Manufacturers must still comply with essential principles, report adverse events, and notify the TGA when supplying exempt devices.
Strategic Takeaway for MedTech Companies
Australia's CDSS framework reflects a broader global regulatory trend. Authorities are not regulating software simply because it incorporates AI; they are regulating the level of influence that software has on clinical decisions.
For developers, the path to smoother market access is clear:
Conclusion
Australia's evolving CDSS regulations demonstrate how regulators are balancing innovation with patient safety. The future of digital health will belong to solutions that empower healthcare professionals with actionable insights while preserving clinical judgment, accountability, and trust.
For MedTech innovators, compliance is no longer just about meeting regulatory requirements. It is about building transparent, clinician-centric technologies that can confidently navigate an increasingly AI-driven healthcare landscape.
Reference
Understanding clinical decision support system software regulation
Switzerland Updates
Swissmedic’s Updated for Products Without an Intended Medical Purpose
Swissmedic has expanded its oversight of certain products without an intended medical purpose under the Swiss Medical Devices Ordinance (MedDO)
Products covered
MedDO under Annex 1 recognizes six categories of products.
Critical Transition Timelines
Products With Planned Clinical Investigations
May remain on the market until 31 December 2029 provided required conditions are met,
Products Without Planned Clinical Investigations
May remain on the market until 31 December 2028 if a written conformity assessment agreement with a designated body exists from 1 January 2027.
Mandatory Registration Requirement
Since 1 July 2026, products covered by Annex 1 MedDO and marketed under the new regulation must be registered with Swissmedic and registration must be completed by 31 December 2026.
Strategic Takeaways for Industry
Organizations should immediately evaluate:
Conclusion
Companies should treat Annex 1 MedDO products with the same regulatory discipline applied to medical devices today.
While transitional provisions provide manufacturers with time to adapt, the intension is clear: safety, clinical evidence, conformity assessment, and market surveillance expectations are equivalent to those applied to traditional medical devices.
ISO Updates
EN ISO 11607-3:2026
The introduction of EN ISO 11607-3:2026 marks an important advancement in medical device packaging by providing a dedicated framework for the development of heat-sealing processes before validation. The previous standards that focus primarily on validation, this new standard emphasizes the importance of building a scientifically justified and well-documented process foundation from the start.
Importance
Sterile packaging is essential for ensuring that medical devices remain safe and effective until its use. A weak or poorly controlled sealing process can compromise the sterile barrier system, potentially affecting product quality and patient safety.
EN ISO 11607-3:2026 addresses this challenge by requiring manufacturers to develop, understand, and document sealing processes before proceeding to validation activities. The standard applies to both preformed sterile barrier systems and sterile barrier systems created during packaging operations.
Key Focus Areas
The standard introduces a structured approach to process development by requiring manufacturers to:
Impact for manufacturer
By encouraging a risk-based and science-driven approach, ISO 11607-3 helps manufacturers establish reliable packaging processes from the start. This can lead to fewer validation challenges, improved operational efficiency, and greater confidence in product quality.
Conclusion
EN ISO 11607-3:2026 fills an important gap within the ISO 11607 family by focusing specifically on process development for forming, sealing, and assembly. By requiring a structured, risk-based, and well-documented approach before validation, the standard helps manufacturers improve packaging consistency, strengthen sterile barrier integrity, and enhance patient safety.
The new standard is more than a technical requirement. It is a roadmap for developing robust and reproducible packaging processes.
To read more visit ISO 11607-3:2026
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.
