UK Updates
The MHRA Approval Process for Clinical Investigations
In July 2026, the Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on approval process for clinical investigations providing clarity on timelines, validation, expert review, and decision-making for studies in Great Britain and Northern Ireland.
Aim
The MHRA aims to process clinical investigation applications in the quickest time while ensuring patient safety. Each application is assessed to confirm that potential risks are minimized and that the anticipated benefits of the investigation justify the risks to participants.
Dual Frameworks: UK MDR vs EU MDR
The guidance reflects the post Brexit regulatory landscape:
Sponsors must carefully identify jurisdiction and tailor submissions accordingly.
Timelines and Validation
Applications are deemed valid once MHRA formally accepts them. Incomplete documentation delays the process, highlighting the need for thorough preparation.
Expert Assessors and Additional Information
Applications are reviewed by multidisciplinary experts in areas such as clinical research, biocompatibility, software safety, and statistics. Sponsors may request exclusion of certain assessors to avoid conflicts of interest.
During review, MHRA may request further information. Sponsors are encouraged to clarify promptly, even arranging calls to resolve issues.
Decisions and Resubmissions
MHRA issues either a Letter of No Objection (Great Britain) or Authorisation Letter (Northern ‑ Ireland). Objections arise if risks are unjustifiable for example, inadequate pre clinical data, weak risk‑benefit analysis, or insufficient safety information.
Resubmissions are permitted once objections are addressed, with lower fees than initial submissions. ‑ Sponsors must provide revised documentation via the IRAS portal, including red lined changes and a covering letter.
Conclusion
The updated MHRA process balances innovation with patient safety. For manufacturers, preparation and jurisdictional awareness are critical. For consultants, this is an opportunity to guide clients through compliance and position themselves as trusted partners.
By embedding rigor and transparency, MHRA ensures that investigational devices meet the highest standards before reaching patients.
Reference
htps://www.gov.uk/government/publicatons/approving-clinical-investgatons/the-mhra-approvalprocess-for-clinical-investgatons
Ambient Voice Technology in Healthcare: MHRA Guidance on Device Qualification and Classification
The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on the qualification and classification of AVT products in Great Britain. This guidance clarifies when AVTs qualify as medical devices under the UK Medical Devices Regulations 2002 (UK MDR) and how they should be classified.
Purpose and Scope of the Guidance
The MHRA guidance aims to:
Importantly, the guidance applies to AVT products intended for the GB market. Under the Windsor Framework, EU MDR applies in Northern Ireland, meaning manufacturers must navigate dual regulatory pathways depending on jurisdiction.
Defining AVT Products
AVTs are AI-driven tools that capture spoken language and generate outputs such as transcripts, summaries, or structured data. In healthcare, they are often used to support documentation drafting discharge summaries, clinical letters, or encounter notes.
Device Qualification: Intended Purpose Matters
Under UK MDR, a product qualifies as a medical device if it is intended for:
Key points:
Regulatory Classification Under UK MDR
If an AVT qualifies as a medical device, classification rules apply:
For AVTs, classification hinges on whether outputs provide decisive diagnostic information. For example, if an AVT determines disease probability or guides treatment decisions, it may be considered Class IIa.
Implications for Manufacturers
Strategic Takeaway
The MHRA guidance states that functionality alone does not define a medical device intended purpose does. Manufacturers must carefully articulate product claims and design safeguards to avoid unintended regulatory obligations.
For consultants and industry leaders, this guidance offers an opportunity to support manufacturers in:
Conclusion
Ambient voice technologies (AVTs) are rapidly transforming healthcare workflows. By automatically capturing and converting spoken words into text, these AI-powered tools promise to reduce administrative burdens, streamline documentation, and enhance patient-clinician interactions. AVTs are powered by generative AI (GenAI) and large language models, enabling flexible, adaptive applications.
Ambient voice technologies promise to revolutionize healthcare documentation and workflows and as they evolve toward diagnostic and therapeutic applications, regulatory clarity is essential. The MHRA’s guidance provides a framework to differentiate administrative aids from medical devices, ensuring that innovation remains safe, effective, and legally compliant.
ReferenceEuropean Updates
MDCG 2026-5: Clarifying UDI Assignment Responsibilities
The Medical Device Coordination Group (MDCG) recently released its Position Paper 2026-5 to address confusion around Unique Device Identification (UDI) assignment responsibilities between manufacturers and distributors. This guidance provides important clarity for industry stakeholders navigating MDR and IVDR compliance.
Background
Some distributors, under agreements with manufacturers, have been assigning UDI-DIs in their own name while keeping manufacturer details on the label. This practice risks duplications and inconsistencies in Eudamed, where the same device could appear under multiple UDI-DIs linked to different entities.
Only the manufacturer may place the UDI on the device or its packaging (Annex VI, MDR/IVDR)
Importance
Clear UDI assignment ensures traceability, transparency, and patient safety across the EU medical device market. By emphasizing manufacturer responsibility, MDCG 2026-5 helps prevent regulatory gaps and strengthens confidence in device identification systems.
Regulatory Framework
Under MDR (EU 2017/745) and IVDR (EU 2017/746):
Conclusion
Manufacturers are the sole entities authorized to assign UDIs.
EU UDI issuing entities must ensure codes are linked to the manufacturer.
Assignment of practical tasks is possible, but legal responsibility cannot be shifted. Distributors, authorized representatives and importers cannot assign UDIs.
TEAM NBUpdates
Team‑NB Position Paper: Risk‑Adaptive Surveillance for Medical Devices
On 30 June 2026, Team NB published a position paper proposing a risk adaptive surveillance system to complement the EU Commission’s proposal COM(2025) 1023 final. This initiative seeks to modernize medical devices surveillance and represents a significant evolution in how notified bodies will monitor manufacturers and devices throughout their lifecycle.
Importance
This proposal describes how notified bodies will implement risk-adaptive surveillance of medical devices and manufacturers.
The affected surveillance activities that will be adjusted according to the applicable risk-adaptive surveillance level include:
Key objectives:
The Commission intends to remove the maximum validity of certificates. Instead of recertifying devices, notified bodies shall carry out periodic reviews proportionate to the risk of the device. This requires a reliable assessment of risk, based on a systematic process.
Increased monitoring intensity at the outset provides the basis for assessing the risks associated with a specific device and its manufacturer, and for determining the future level of monitoring based on that assessment.
Proposed Amendments to MDR
The position paper suggests several amendments to Regulation (EU) 2017/745:
Implications for manufacturer
Manufacturers must maintain robust post market surveillance (PMS) and quality management systems (QMS) to qualify for reduced surveillance.
Conclusion
The Team NB proposal represents a significant evolution in MDR surveillance. By shifting from fixed certificate validity to risk adaptive monitoring, the proposal promises better efficiency, responsiveness and patient safety.
USA Updates
Medical Devices; Radiology Devices; Classification of the Phase-Changing Fiducial Marker for Radiation Therapy
On July 29, 2026, the U.S. Food and Drug Administration (FDA) issued a final order classifying the phase-changing fiducial marker for radiation therapy into Class II. This decision is a significant regulatory milestone, balancing patient safety with innovation in radiology devices. By moving the device from automatic Class III assignment to Class II, FDA reduces regulatory burdens while ensuring robust safeguards.
Background
Under U.S. law, any device not marketed before May 28, 1976, is automatically assigned to Class III, requiring premarket approval (PMA). This includes post amendments devices like the phase-changing fiducial marker.
FDA can reclassify such devices through:
Special Controls Codified in Regulation
FDA codified the classification under 21 CFR 892.5727, requiring:
Implications for manufacturers
Conclusion
The classification of the phase-changing fiducial marker into Class II is not just a regulatory step it is a gateway for innovation in radiation therapy. FDA’s classification of the phase-changing fiducial marker demonstrates a balanced regulatory approach which encouraging innovation by reducing burdens and ensuring safety through robust special controls. It creates a predicate pathway for future devices, fostering competition and innovation.
By codifying special controls, FDA ensures that manufacturers can bring advanced devices to market more efficiently while maintaining high standards of safety and effectiveness.
ReferenceAustralia Updates
Understanding Australia's DAEN
The Database of Adverse Event Notifications (DAEN) is the Therapeutic Goods Administration’s (TGA) online resource that captures reports of suspected adverse events involving medical devices in Australia. Updated in July 2026, the DAEN is a critical tool for monitoring device safety, identifying potential risks, and supporting regulatory oversight.
DAEN Contains
It should be noted that DAEN is not a comprehensive safety assessment tool. It provides signals, not conclusions.
Limitations of the TGA's Database of Adverse Event Notifications (DAEN)
Conclusion
The DAEN is a cornerstone of Australia’s medical device vigilance framework. Although it cannot provide definitive safety conclusions, it plays a vital role in early detection of potential risks. For stakeholders, the message is clear: use DAEN as part of a broader safety evaluation strategy, combining regulatory data, manufacturer information, and clinical evidence.
By maintaining DAEN, the TGA strengthens public trust in medical devices and ensures that safety signals are not overlooked. Transparency, even with limitations, is essential in a rapidly evolving MedTech landscape.
ReferenceSwitzerland Updates
Swissmedic’s relaxation for Non-Conforming Medical Devices
Published July 2026, Version 5.0 (BW617_00_003)
Swissmedic published Version 5.0 of its information sheet on derogation (MEP), clarifying the framework for authorising the placing on the market and putting into service of medical devices in Switzerland.
Importance
Under the Medical Devices Ordinance (MedDO) and In Vitro Diagnostic Medical Devices Ordinance (IvDO), devices are required to undergo conformity assessment before they are placed on the market. However, in exceptional cases such as urgent public health needs or serious patient safety concerns Swissmedic can grant derogation to allow use of non-conforming devices.
Reason for Derogations
Normally, manufacturers must prove conformity before marketing a device. However, situations arise where:
In such cases, Swissmedic may grant an exemption authorisation under Art. 22 MedDO / Art. 18 IvDO, provided the application is justified and patient safety is prioritized.
Eligible Applicants
Applicants must be based in Switzerland and may include:
They must accept full responsibility for device safety, performance, incident reporting, and post-market surveillance.
Application Requirements
A robust application must include:
Fees
Administrative activities are charged at CHF 270/hour under the updated Swissmedic Fee Ordinance (GebV-Swissmedic).
Individual Case Exemptions Without Swissmedic Authorization
Swiss law permits use of non-conforming devices without Swissmedic approval in individual cases (Art. 22 para. 2 MedDO / Art. 18 para. 2 IvDO), provided:
India Updates
India's New Guidance Document on Medical Device Software
The Central Drugs Standard Control Organization (CDSCO) has published a landmark Guidance Document on Medical Device Software (MDSW) under the Medical Devices Rules, 2017 (MDR-2017). This document establishes a clear regulatory framework for software intended for medical purposes in India.
What's Changing?
The guidance document clarifies that software intended for medical purposes whether standalone or integrated with hardware now falls under the purview of India's Drugs & Cosmetics Act, 1940 and the MDR-2017. This includes everything from AI-powered diagnostic tools to mobile health apps that assist in disease management.
Key Highlights of the Guidance
1. Scope and Coverage
The document covers Medical Device Software (MDSW) that is:
2. Not Covered
Not all healthcare software qualifies as MDSW. The guidance clarifies that:
3. Risk-Based Classification
MDSW is classified into four risk categories (Class A-D) based on:
Critical situations (life-threatening conditions requiring timely intervention) warrant higher classification, while non-serious situations (chronic conditions with predictable progression) may have lower risk classification.
4. Quality Management System Requirements
Manufacturers must implement robust Quality Management Systems (QMS) covering:
5. Digital Health Ecosystem Alignment
The guidance emphasizes integration with India's digital health initiatives:
6. Post-Market Surveillance
Manufacturers must implement ongoing monitoring:
Regulatory Pathway
The document outlines clear pathways for:
Applicable Standards
MDSW must conform to a comprehensive list of international and Indian standards, including:
Submission Process
Applications must be submitted through designated online portals:
Impact on Manufacturers and Importers:
Conclusion
In India's evolving digital health regulatory landscape, the CDSCO's Medical Device Software Guidance, 2026 is an important milestone. The guidance aims to help manufacturers, importers, innovators, and regulatory professionals in understanding India's regulatory expectations for Medical Device Software (MDSW) and In Vitro Diagnostic (IVD) Medical Device Software.
It also provides important clarity on the classification, scope and regulatory expectations for Medical Device Software.
https://cdsco.gov.in/opencms/opencms/en/Medical-Device-Diagnostics/Medical-Device-Diagnostics/
ISO Updates
ISO/TS 17664‑3:2026 – Cleaning Classifications for Reusable Medical Devices
Reusable medical devices are becoming important in modern healthcare, but their safe reprocessing depends on clear, validated instructions. With the release of ISO/TS 17664‑3:2026, the industry now has a dedicated framework for cleaning classification categories. This bridges the gap between manufacturers who design devices and the facilities that process them, ensuring patient safety and regulatory compliance.
What the Standard Covers
According to the scope of the document:“This document gives guidance on designating medical devices to cleaning classification categories, attributes used for medical device cleaning classification category, and designation of a cleaning process.”
Importance
Earlier standards such as ISO 17664‑1 and ISO 17664‑2 focused on labelling and sterilization requirements. This new Part 3 fills the gap, completing related documents like AAMI TIR12 and ANSI/AAMI ST98, which reference product families but lacked objective designation methods.
Key elements include:
Classification System:
Categories Defined:
Risk Analysis & Complexity: It emphasize risk analysis, device complexity, and cleaning risk mitigation.
Conclusion
The publication of ISO/TS 17664-3:2026 is a landmark for the MedTech industry. By standardizing cleaning classification categories, it enhances patient safety and ensures global regulatory alignment. For manufacturers it is time for updating technical files and IFUs.
To read more visit: https://lnkd.in/dGWGGGfs
ISO 24971 Updates: Risk Management Guidance for Medical Devices
The International Organization for Standardization (ISO) has advanced several important technical specifications under the ISO 24971 series, designed to provide practical guidance on the application of ISO 14971:2019, the global standard for medical device risk management. These updates reflect the evolving complexity of MedTech from traditional devices to AI-driven systems and combination products.
ISO/AWI TS 24971-1 – General Guidance
Currently under development, ISO/AWI TS 24971-1 will replace ISO/TR 24971:2020.
Key Highlights:
This specification will serve as the foundational guidance for manufacturers seeking consistent application of ISO 14971.
ISO/TS 24971-2:2026 – AI/ML in Medical Devices
Published in 2026, ISO/TS 24971-2 extends ISO 14971 to devices incorporating machine learning (ML) and artificial intelligence (AI).
Key Highlights:
This guidance bridges traditional risk management with the realities of adaptive, data-driven technologies.
ISO/CD TS 24971-3 – Combination Products
In committee draft stage, ISO/CD TS 24971-3 focuses on drug–device and biologic–device combination products.
Key Highlights:
This specification harmonizes risk management across medical devices and pharmaceuticals.
Conclusion
The ISO 24971 updates represent a strategic expansion of risk management guidance:
Together it provides manufacturers with a clearer roadmap for managing risks and supporting regulatory compliance.
To read more visit:
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