UK Updates
MHRA Publishes National Commission Recommendations on Regulating AI in Healthcare
Artificial Intelligence is rapidly transforming healthcare, creating new opportunities to improve patient outcomes, clinical decision-making, and operational proficiency.
The UK MHRA has now published the National Commission's recommendations on regulating AI in healthcare, highlighting the need for a framework that balances innovation with patient protection.
Key areas of focus include:
Task for manufacture
For MedTech companies, particularly those developing Software as a Medical Device (SaMD) and AI-enabled solutions, the report signals important future regulatory expectations.
Manufacturers will increasingly need to demonstrate:
Rather than viewing regulation as a hurdle, the Commission positions it as an enabler of safe innovation.
Global Implications
Although the report was commissioned by the UK MHRA, its recommendations have broader significance.
Global regulators including the FDA, Health Canada, EU authorities, and international regulatory forums are facing similar challenges:
The Commission's recommendations may therefore influence future international harmonization efforts in AI regulation.
Conclusion
The National Commission into the Regulation of AI in Healthcare makes a compelling case that regulating AI requires a fundamentally different mindset than regulating traditional medical devices. Instead of relying on a one-time approval process, healthcare regulators must embrace a lifecycle approach that combines proportionate oversight, shared responsibility, and continuous learning.
For healthcare providers, regulators, and AI developers alike, the message is clear: the future of AI in healthcare will not be measured solely by innovation. It will be measured by our ability to ensure that innovation remains safe, transparent, equitable, and trusted.
As AI becomes increasingly embedded in healthcare delivery, the winners will not simply be those who build the most advanced algorithms. They will be the organizations that can demonstrate responsible governance, continuous performance assurance, and commitment to patient safety.
Reference
European Updates
MDCG 2020-16 Rev. 5
The latest updated document, MDCG 2020-16 rev.5, Guidance on Classification Rules for In Vitro Diagnostic Medical Devices under Regulation (EU) 2017/746, provides updated clarification and examples to support manufacturers, notified bodies and other stakeholders in applying Annex VIII of the IVDR.
Key updates introduced in revision 5
Important classification
1. Intended Purpose
One of the most important principles highlighted in MDCG 2020-16 rev.5 is that classification is driven by the manufacturer's intended purpose.The guidance strongly emphasizes that device classification is determined by intended purpose as specified in labelling, Instructions for Use (IFU), sales materials, and technical documentation.
2. Software Classification
Software that drives or influences an IVD inherits the classification of the associated device. Standalone software must be classified in its own right according to its intended purpose.
3. Devices used in combination must be evaluated separately
Manufacturers should assess each component individually, including:
High-Risk Categories
Several categories remain subject to Class C or Class D classification due to their potential impact on public health and patient safety:
Class D Examples
Class C Examples
Practical Takeaway for Manufacturers
Classification errors can significantly affect regulatory timelines, conformity assessment strategy, notified body engagement, and market access planning.
Manufacturers should revisit:
Conclusion
The publication of MDCG 2020-16 Rev. 5 further strengthens regulatory clarity under IVDR and provides valuable guidance for manufacturers navigating increasingly complex classification requirements. By carefully applying the principles and examples provided in the guidance, organizations can reduce regulatory uncertainty, strengthen compliance, and facilitate smoother market access across the European Union.
For guidance visit https://lnkd.in/ghhvbEec
USA Updates
FDA Draft Guidance on Electronic Submission Template for PMAs
The U.S. Food and Drug Administration (FDA) issued draft guidance on September 18, 2026, introducing the electronic submission template framework for Premarket Approval Applications (PMAs) and certain PMA supplements. The draft is intended for applicants submitting to FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER).
What submissions are covered?
The draft addresses electronic submissions for:
It does not currently cover PMA Modules and Modular Shells.
eSTAR: The electronic submission template
FDA identifies eSTAR (electronic Submission Template And Resource) as the currently available electronic submission template for PMAs and PMA supplements.
The structured dynamic PDF guides applicants through preparation of a complete submission using questions, prompts, logic and relevant FDA resources. It also incorporates integrated databases, including FDA product codes and FDA-recognized consensus standards.
The template is designed to organize information covering areas such as:
Technical screening of eSTAR submissions
FDA anticipates conducting technical screening of PMA eSTAR submissions within 15 calendar days of receipt, provided the applicable user fee has been paid.
If deficiencies are identified, the submission may be placed on hold until additional information is provided. Once the submission passes technical screening, it can proceed to substantive review.
Proposed implementation timeline
The draft states that, following finalization, FDA intends to provide a minimum one-year transition period before requiring the designated PMA application types to be submitted electronically.
During the transition period, eSTAR may be used voluntarily for PMAs and PMA supplements.
Waivers and exemptions
FDA proposes exemptions for certain submissions and information, including:
At this stage, FDA has not identified particular circumstances for waivers and indicates that applicants should generally be able to provide a PMA eSTAR.
Final thought
The FDA's draft guidance on Electronic PMA Submission Templates reflects a broader transformation in how medical device applications will be prepared, reviewed, and managed in the future.
By embracing structured electronic submissions, the FDA aims to improve submission quality, regulatory efficiency, and consistency across the PMA review process. For manufacturers, the guidance provides a clear signal that digital readiness is becoming an essential component of regulatory success.
Reference
Australia Updates
TGA Clinical Evidence Guidelines for Medical Devices: Key Updates for Manufacturers
The Therapeutic Goods Administration (TGA) provides guidance to help sponsors and manufacturers collect, compile and present clinical evidence under the Australian regulatory framework. The guidance relates to the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002.
Key developments in the guidance
The TGA's clinical evidence guidance has evolved significantly since its original publication in February 2017.
Real-World Data (RWD) and Real-World Evidence (RWE)
The November 2023 update added references to RWD and RWE and updated the section on other clinical experience data.
Software as a Medical Device (SaMD)
A new chapter on SaMD was introduced in June 2022, reflecting the growing role of software-based medical technologies.
Personalised Medical Devices (PMDs)
The June 2022 update also introduced a chapter addressing personalised medical devices, alongside updates concerning total and partial joint prostheses.
Specialised device categories
The November 2023 update included new or revised material covering ophthalmic devices, medical devices incorporating a medicine, surgical mesh, breast implants and tissue expanders and CNS patches and tissue adhesives.
Computational modelling and simulation
The latest update, dated 11 September 2026, added a section on the use of computational modelling and simulation.
Task for manufacturers
The continued evolution of the guidance highlights the importance of maintaining a current and device-specific clinical evidence strategy.
Manufacturers and sponsors should consider whether their clinical evidence approach properly addresses:
The TGA guidance is intended as a reference for both industry and regulators and supports manufacturers and sponsors in collecting, compiling and presenting clinical evidence.
Staying current matters
The TGA guidance was originally published on 1 February 2017 and has undergone multiple updates. The latest page update was 11 September 2026.
For medical device manufacturers, keeping clinical evidence strategies aligned with current regulatory guidance is an essential part of maintaining an effective regulatory pathway in Australia.
Reference
https://www.tga.gov.au/resources/guidance/clinical-evidence-guidelines-medical-devices
Brazil Updates
ANVISA Releases New 2026 Guidance for Medical Device Notification
In 2026, Brazil’s health authority ANVISA published a comprehensive manual on the notification of medical devices, specifically targeting Class I (low risk) and Class II (medium risk) products. This guidance provides manufacturers, importers, and distributors with clear, step-by-step instructions to ensure compliance with Brazil’s evolving regulatory framework.
Purpose of the Manual
The manual aims to:
Key Features
Risk-Based Classification
Notification Process
The manual outlines six steps for notification:
Documentation
Post-Notification Obligations
Implications for manufacturers
Manufacturers must ensure accurate risk classification under RDC 751/2022, maintaining audit-ready documentation even for Class I and II devices, securing proper company authorizations (AFE and LF) before petitioning, and mastering electronic submissions via the Solicita system.
Conclusion
ANVISA’s 2026 manual represents a modernized, transparent, and internationally aligned framework for medical device notification. By clarifying classification rules, streamlining electronic submissions, and reinforcing compliance obligations, ANVISA is strengthening Brazil’s regulatory environment while facilitating access to safe, effective, and high-quality medical devices.
ISO Updates
ISO Medical Device Standards Update (1 August – 1 September 2026)
The period from 1 August to 1 September 2026 witnessed several noteworthy developments across the ISO landscape. The updates include newly registered Committee Drafts (CDs), Draft International Standards (DIS), Final Draft International Standards (FDIS), and newly published standards spanning biological evaluation, artificial intelligence, implants, in vitro diagnostics and health informatics.
TC 194 Biological and clinical evaluation of medical devices.
TC 210 Quality management and corresponding general aspects for products with a health purpose including medical devices
Significant Progress for In Vitro Diagnostic Devices
Implant Standards
ISO TC 150 Implants for surgery
To read more visit https://lnkd.in/g2ShZ7g6
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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
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