UK Updates
UK International Recognition Framework for Medical Devices — March 2026 Policy Update
On 12 March 2026 the Medicines and Healthcare products Regulatory Agency (MHRA) published a Statement of Policy Intent describing how Great Britain will recognise approvals from trusted international regulators. The policy is designed to reduce duplication, speed patient access to safe devices, and shape the UK’s post Brexit medical device regime.
Background
Key Features
1. Comparable Regulator Countries (CRCs) Devices approved by the following regulators may qualify for recognition:
2. Eligibility requirements To be eligible, products must:
3. Access routes
4. Exclusions International recognition will not apply to:
5. Northern Ireland goods CE marked devices placed on the market in Northern Ireland will retain indefinite access to the Great Britain market under the UK Internal Market Act 2020.
Conclusion
The MHRA’s March 2026 policy intent to moves the UK toward greater international alignment by recognising trusted foreign approvals while retaining UK specific safeguards.
To read more visitEuropean Updates
EU Artificial Intelligence Act — March 2026 Implementing Regulation
On 12 March 2026 the European Commission published a draft implementing regulation under the Artificial Intelligence Act (Regulation (EU) 2024/1689). The regulation specifies how the Commission will evaluate general purpose AI models and manage proceedings against providers.
Key highlights
1. Access to AI models
2. Independent experts
3. Opening and closing proceedings
4. Procedural safeguards
5. Confidential information
6. Limitation periods
7. Digital transmission
Implications
Conclusion
The March 2026 implementing regulation under the AI Act marks a decisive step by clarifying procedures for model evaluations, expert involvement and enforcement. The regulation clarifies that providers should be ready for increased transparency, independent scrutiny and digital-first compliance.
EU Expands List of Well Established Technologies Under MDR – March 2026 Update
On 20 March 2026, the European Commission adopted a Delegated Regulation amending the MDR (EU 2017/745). This update expands the list of implantable and class III devices considered Well Established Technologies (WET), exempting them from the obligation to perform clinical investigations.
Context
Key Changes in March 2026
The updated regulation broadens the exemption list to include additional implantable and class III devices such as:
Important Safeguards
Conclusion
The March 2026 Delegated Regulation reflects the EU’s realistic approach to medical device oversight. It will help in maintaining patient safety while reducing unnecessary regulatory burden for well established technologies. By increasing the exemption list, the Commission recognizes decades of safe use and performance data, allowing resources to focus on newer, higher risk innovations.
USFDA Updates
FDA’s 2026 Guidance on Weight Loss Devices – Premarket Considerations
On March 13, 2026, the U.S. Food and Drug Administration (FDA) issued new guidance titled Medical Devices with Indications Associated with Weight Loss – Premarket Considerations. This document provides detailed recommendations for manufacturers preparing premarket submissions for devices intended for weight loss, weight reduction, weight management, or obesity treatment.
Importance
Obesity remains a major public health challenge, and medical devices are increasingly used to support weight loss. These devices vary in design, risk, and effectiveness. The FDA’s guidance aims to:
Scope of Devices Covered
The guidance applies to devices such as:
These devices fall under various product codes and regulatory classifications, with some subject to special controls (e.g., biocompatibility, labeling, performance testing).
Key Premarket Submission Recommendations
1. Device Description
Manufacturers must provide:
2. Labelling
3. Non Clinical Testing
4. Clinical Performance Testing
5. Benefit Risk Considerations
Impact
Conclusion
The FDA’s March 2026 guidance sets a comprehensive framework for weight loss devices, ensuring that innovation is matched with patient safety. By clarifying premarket submission requirements, it helps manufacturers design better studies, produce stronger evidence, and ultimately deliver safer, more effective devices to patients.
Australian Updates
Understanding TGA’s Software-Based Medical Device Exclusions
Published: March 2026
As digital health advances, distinguishing between consumer wellness tools and regulated medical devices is crucial. To foster innovation while ensuring patient safety, the Therapeutic Goods Administration (TGA) offers clear guidelines on which software types are regulated as medical devices in Australia.
On March 16, 2026, the TGA updated its list of software-based medical device exclusions, detailing 15 categories of software that do not need to be included in the Australian Register of Therapeutic Goods (ARTG), provided the product meets specific criteria.
Excluded Software
Under section 41BD of the Therapeutic Goods Act 1989, software defined as a medical device is usually regulated. However, certain software types are designated as excluded goods under the Therapeutic Goods (Excluded Goods) Determination 2018.
These products:
If a product meets all conditions in the Determination, no submission, registration, or TGA interaction is necessary before commercialization. However, if any function of the software fails to meet exclusion criteria, the entire product becomes regulated. The TGA emphasizes that software with multiple functions must ensure each function independently qualifies for exclusion.
The 15 Categories of TGA Excluded Software (2026 List)
Below is an overview of the categories excluded by the TGA, each accompanied by a guidance document for developers.
1. Behavioral Change & Coaching Software
Tools encouraging healthier habits may qualify for exclusion.
2. Calculator Software
Simple calculators performing deterministic calculations (e.g., dosage calculators under strict conditions).
3. Clinical Workflow Management Software
Tools supporting administrative workflow, not clinical decision-making.
4. Communications Software
Platforms supporting healthcare delivery without interpreting clinical data.
5. Digital Mental Health Tools (DMHT)
Consumer apps offering general mental well-being support may be conditionally excluded.
6. Electronic Health Records (EHR) Software
Systems used solely for storing and accessing patient information.
7. General Health & Wellness Software
Apps promoting overall health (fitness, sleep, diet trackers) without treatment recommendations.
8. Health Alert Software Systems
Tools issuing alerts to clinicians provided they do not interpret or transform clinical data.
9. Health Facility Management Software
Administrative systems managing health facility operations or logistics.
10. Health Self Management Software
Consumer tools supporting self-management of diagnosed conditions within specific boundaries.
11. Image Storage & Transmission Software
Software for storing or transmitting medical images without analysis.
12. Laboratory Information Management Software (LIMS)
Systems managing lab operations, excluding those that interpret diagnostic results.
13. Middleware
Software connecting systems or devices, provided it does not make clinical inferences.
14. Patient Survey Software
Tools collecting patient-reported outcomes without interpreting clinical meaning.
15. Population Based Analytics Software
Analytics tools for epidemiology or health service planning, not individual patient diagnosis.
Importance
Understanding these categories can significantly reduce the regulatory burden for digital health innovators. By structuring your software to fit within the exclusion definitions, you can:
Conclusion
The TGA’s 2026 update to software-based medical device exclusions offers essential clarity for digital health innovators. With 15 defined categories, developers can better assess whether their software must be regulated or can operate without ARTG inclusion. Building software that fits within these criteria can streamline your commercialization pathway, but only if every feature meets the TGA’s rules.
ISO Updates
ISO 20417:2026 – Medical devices -Information to be supplied by manufacturer
The newly published ISO 20417:2026 specifies the requirements for the information that manufacturers must supply with medical devices and accessories as defined in 3.1.
What ISO 20417:2026 Covers
ISO 20417 specifies requirements for:
The standard does not specify how the information must be supplied what must be included.
Jurisdictional Differences
While ISO 20417 provides a global structure, manufacturers should note:
Importance
For manufacturers, compliance with ISO 20417:2026 is very important. It ensures:
Practical Steps for Manufacturers
To align with ISO 20417:2026, manufacturers should:
Final Thought
ISO 20417:2026 is not just a regulatory update it’s a framework for clarity and trust. By adopting its requirements early, manufacturers can strengthen compliance, streamline audits, and build confidence with regulators, clinicians, and patients alike.
For guidance visit Sushvin @ sushvin.com/index.html
To read more visit https://lnkd.in/gaGrSmC2
ISO 14155:2026 — Clinical investigations of medical devices for human subjects: Good Clinical Practice
In March 2026, the International Organization for Standardization (ISO) published the fourth edition of ISO 14155:2026, updating the global Good Clinical Practice (GCP) standard for medical device investigations.
Importance of ISO 14155:2026
Clinical investigations are the backbone of medical device approval. Clinicians, and patients rely on to evaluate new medical technologies. ISO 14155:2026 helps ensure investigations:
Key changes in ISO 14155:2026
Strategic implications
Conclusion
ISO 14155:2026 is a strategic update that strengthens GCP for medical device investigations. Early adoption can improve patient safety, streamline regulatory approvals, and offer a competitive advantage in a market increasingly focused on transparency, digital health, and patient centered outcomes.
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.
