UK Updates
MHRA’s Standardized PMSR Format: A New Standard for Post-Market Vigilance
The Medicines and Healthcare products Regulatory Agency (MHRA) has released a detailed guide on the new standardized format for Post-Market Surveillance Reports (PMSRs) under the updated Medical Devices Regulations 2024. This guide sets a new standard for how manufacturers should organize, analyze, and present post-market data.
Why This Matters?
Post-market surveillance is now an active process that helps with risk management, regulatory compliance, and product decisions.
Key Parts of the PMSR Format
1.Cover Page & Executive Summary
2. Device Description
3. Device Performance Information
It should include analysis of:
4. Additional Surveillance Data
5. Preventive and Corrective Actions (CAPA)
6. Findings and Conclusions
European Updates
EU Releases Manufacturer’s Trend Report Form (MTR) – Version 1.0
The EU has released Version 1.0 of the Manufacturer’s Trend Report Form (MTR). This is an important step in improving how medical devices are monitored after they are on the market, following the rules set by MDR 2017/745 and IVDR 2017/746.
Why it matters: Trend reporting (Article 88) is now official. It helps manufacturers notice & report any significant increases in problems with devices, even if those problems don’t need to be reported right away under Article 87. This helps identify safety or performance issues early, which could affect the benefits and risks of the devices.
The MTR Form helps to:
This is a significant move toward better safety and risk management in the medical device industry.
Understanding the EU AI Act: TÜV SÜD Offers Free Risk Classification Tool
The European Union has introduced the AI Act, and it's changing how artificial intelligence (AI) is regulated. For companies working with AI, it's crucial to grasp these new rules, and TÜV SÜD is here to help.
Easier Navigation of the EU AI Act
The AI Act focuses on the risks associated with AI systems. TÜV SÜD has created the AI Act Risk Navigator to simplify this process.
This online tool helps classify AI systems into the four risk categories defined by the EU AI Act:
Why This Tool is Important?
Failing to comply with the AI Act can lead to hefty fines up to €15 million or 3% of a company’s global revenue. High-risk AI systems, such as those used in healthcare or employment, face strict mandatory requirements.
This tool helps businesses:
Final Thoughts
The AI Act Risk Navigator is not just a compliance tool; it’s a strategic asset for any organization building or deploying AI in Europe. By simplifying complex legal requirements, TÜV SÜD empowers teams to act early, align with regulation, and build AI systems that are not only innovative but also safe and ethical.
To read more about this AI Act tool visit:
Important Updates from the EU Borderline & Classification Manual (Version 4 – Sept 2025)
In the changing world of EU medical device rules, having clear information is crucial. This is especially true for borderline products those that can be seen as medical devices, cosmetics, biocides, or even food. The release of Version 4 of the Manual on Borderline and Classification under Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR) is significant for manufacturers, regulators, and consultants.
What’s New in Version 4?
Released in September 2025, this updated manual includes the latest insights from the Borderline and Classification Working Group (BCWG). While it isn't legally binding, it serves as an important reference for understanding MDR and IVDR across Europe.
Key updates include:
Why Borderline Matters?
Deciding on product classifications is crucial; it can impact the entire regulatory process. Misclassifying products can lead to delays, rejections, or even being pulled from the market.
So, understanding this manual is vital.
Final Thoughts
In a regulatory environment where a single word in the product claim can change the classification, staying well-informed is essential. The updated manual is more than just a guide; it’s a strategic tool for anyone working in the EU medical device and IVD fields.
If not sure about the product, review the manual or consult with an expert.
To read more visit
Understanding the EU HTA Regulation (EU) 2021/2282
The European Commission has published its first official FAQ document about the Health Technology Assessment (HTA) Regulation (EU) 2021/2282. This important framework aims to standardize how health technologies are evaluated across the EU.
Key Points from the FAQ
1. Scope of Joint Clinical Assessments (JCAs)
JCAs apply to medicinal products that:
2. Stepwise Implementation Timeline
The HTA Coordination Group (HTACG) will start with a few JCAs and gradually increase the number.
This gradual rollout allows stakeholders to adapt systems and processes.
3. Variation and New Indications
Once a Joint Clinical Assessment (JCA) has been completed for a product, any future change like adding a new therapeutic use will require another JCA, no matter the type of regulatory variation involved.
4. Conditional Authorisations
JCAs apply equally to conditional and standard marketing authorisations. Updates to JCA reports may be required if additional evidence becomes available post-authorisation.
5. Diagnostics and Companion Tests
Only Class D IVDs are within scope. Companion diagnostics typically classified as Class C are excluded from JCAs under this regulation.
Strategic Implications for Developers
Plan Ahead: HTDs should prepare for JCA timelines and align their regulatory and market access strategies.
Team Collaboration: Regulatory, clinical, and reimbursement teams must work together to meet HTA requirements.
Access the official FAQ document from the European Commission
EU MDR Language Requirements – Rev. 3 (August 2025)
The European Commission has released the third version of the MDR Language Requirements for Manufacturers. This update provides guidance on how to present medical device information in different EU Member States. It’s not just a technical revision; it signals the need for manufacturers to be aware of multilingual obligations under Regulation (EU) 2017/745.
National Language Requirements
According to Article 10(11) and Annex I of the MDR, manufacturers must provide information about a device in the language required by each Member State. Rev. 3 presents these requirements in a country-by-country table, showing legal requirements and accepted languages.
English as an option with conditions
The Commission suggests that Member States may accept documents in English, especially for devices meant for professional use, as long as safety is not affected.
Professional vs. Public Use
Language requirements vary based on the intended user:
Understanding this difference is vital for manufacturers working in diverse markets and with various user groups.
Final Thoughts
Version 3 of the MDR Language Requirements reminds us that regulatory alignment does not mean uniform language use. For manufacturers, this is a chance to rethink documentation strategies, improve translation processes, and communicate with notified bodies about best practices.
To read more visit 2025.08_Language Requirements for Manufacturers_MDR_Rev.3
Team-NB’s Best Practice Guidance for IVDR Technical Documentation
A Unified Approach to Conformity Under Annex II & III of Regulation (EU) 2017/746 Team-NB has released Version 2 of its Best Practice Guidance to help with the submission of technical documentation under the In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746. This guide aims to make it easier for manufacturers to show they meet safety and performance requirements.
Why This Guidance Matters
Technical documentation is essential for proving a product's safety and compliance. Different interpretations of the requirements by various notified bodies have caused confusion, delays, and extra work for manufacturers.
Team-NB’s guidance aims to:
Scope and Structure
This guidance applies to all classes of IVD medical devices and covers:
The documentation must reflect the current status of the device according to the manufacturer’s Quality Management System (QMS).
Language Requirements
When submitting documentation, manufacturers must ensure it is in a language accepted by the reviewing organization. This emphasizes the need for companies to be ready to work in multiple languages, especially in different EU markets.
Takeaways for Manufacturers
USFDA Updates
FDA's New Computer Software Assurance Guidance: A Modern, Risk-Based Approach to Validation
The U.S. Food and Drug Administration (FDA) has introduced new guidance for medical device manufacturing regarding Computer Software Assurance (CSA), released in September 2025. This updated document offers a flexible, risk-based method for validating software used in production and quality systems.
The CSA Risk Framework
The guidance provides a simple framework for implementing CSA, which includes several key steps:
1. Identify the Intended Use
Define how the software is used in production or quality systems. This includes:
2. Determine the Risk-Based Approach
Analyze the software's features to assess potential risks to patient safety.
3. Select Appropriate Assurance Activities
Choose testing methods based on risk level.
4. Establish the Appropriate Record
Keep documentation proportional to the risk, demonstrating that the software performs as intended without excessive detail for lower-risk functions.
Strategic Implications for manufacturer
For manufacturers and sponsors, CSA provides a way to:
Conclusion:
The FDA's CSA guidance modernizes regulatory expectations, aligning them with current software engineering practices. By adopting this risk-based approach, medical device manufacturers can achieve compliance more efficiently without affecting safety.
Canada Updates
Health Canada’s GMP Guide for Natural Health Products (2025) Version 4.0
Health Canada has released Version 4.0 of its Good Manufacturing Practices (GMP) Guide for Natural Health Products (NHPs). This new guide, effective from March 4, 2026, replaces Version 3.0 .
Who Should Read This Guide?
The updated GMP guide applies to all individuals and organizations involved in:
Even though distribution and storage don’t require a license under Part 2 of the Natural Health Products Regulations, they must now follow GMP requirements under Part 3, especially for importers and e-commerce platforms.
Key Updates in Version 4.0
1. Broader Scope and Definitions
2. Quality Systems
3. Finished Product Testing
4. Documentation and Data Integrity
Industry Implications
Read Health Canada’s official guidance at
Health Canada’s Updated Guidance on Medical Device Application Types: A Simple Guide for 2025
Navigating Health Canada’s licensing process can be tricky, especially when figuring out the right application type for medical devices and in vitro diagnostic devices (IVDDs). Health Canada’s latest guidance provides a clear way for manufacturers to simplify their submissions under the Medical Devices Regulations (Parts 1 & 1.1).
Understanding the Application Types
Health Canada describes several application categories, each with specific rules and document requirements:
Special IVDD Cases
Labeling Requirements
Final Thoughts
Health Canada’s updated guidance shows a trend toward clearer regulations. By understanding and using the correct application type, manufacturers can speed up market access, reduce paperwork, and stay compliant with product lines.
Australian Updates
A Simple Guide to Australia's Rules for Software and AI Medical Devices
Healthcare is becoming more digital, with apps that track health and AI that helps in diagnosing illnesses. But how are these tools regulated to ensure they are safe for Australians?
Australia's Therapeutic Goods Administration (TGA) has released guidance called Understanding regulation of software-based medical devices.
This blog highlights the main points for developers, manufacturers, and healthcare providers.
What is a Regulated Software Medical Device?
Not every health app is a medical device. The TGA regulates software (including mobile apps) only if it qualifies as a medical device under the Therapeutic Goods Act 1989.
In simple terms, if the software is meant for:
This includes Software as a Medical Device (SaMD) that runs on smartphones, Digital Therapeutics (DTx) that provide medical treatment, and even advanced AI and large language models (LLMs) like ChatGPT when used for medical purposes.
However, general health apps that only provide information or track fitness are not regulated by the TGA.
Key Points from the TGA's Guidance
1. A Risk-Based Approach
The TGA focuses on software that poses the highest risk. They prioritize products that fit the medical device definition but aren't exempt and aren't listed on the ARTG.
2. Special Note: Baby Movement Apps
The TGA warns about apps that monitor fetal movements. They consider these medical devices since they aim to prevent harm to the fetus. These apps must be listed in the ARTG, and any suspected issues should be reported.
3. Clarification on Hardware
A key update clarifies that for SaMD using sensors in devices like smartphones, the device itself doesn't need to be listed in the ARTG. However, the software must be thoroughly tested to ensure it is safe and effective for its medical use.
4. The Rise of AI and LLMs
The guidance discusses the growth of AI. It states that the rules apply equally to any technology, whether it’s an AI chatbot, a cloud algorithm, or a mobile app, as long as it serves a medical purpose.
If a developer uses an LLM like GPT-4 for Australian patients, they are responsible for ensuring safety and performance standards are met.
5. International Consistency
The TGA is part of the International Medical Device Regulators Forum (IMDRF) and is involved in creating a global approach to regulating SaMD, aligning with best practices worldwide.
Resources for Developers and Manufacturers
The TGA offers various resources to help navigate these regulations:
The Bottom Line
Australia's rules for software-based medical devices are established, risk-focused, and support innovation while ensuring patient safety. The same rules apply to both simple apps and complex AI, based on the intended use of the software.
For developers, it’s crucial to understand the regulations early in the design process. Use the TGA's resources to figure out if your product is a medical device and what compliance steps you need to take.
For healthcare providers and consumers, this framework assures that the digital health tools used have been evaluated for safety and effectiveness by a reliable regulator.
Always check the official TGA guidance for the latest information: Understanding regulation of software-based medical devices
Navigating TGA Medical Device Audits: A Simple Guide to New Selection Criteria
In September 2025, the Therapeutic Goods Administration (TGA) released important guidance titled "Understanding Selection Criteria for Medical Device Application Audits."
This document is vital for all medical device sponsors. It explains how the TGA chooses which applications to audit.
Importance of an audit
The TGA focuses on applications that pose the highest risk to patient safety and public health. Audits are a key method to ensure devices meet Australian standards before they are sold.
The new guidance states that while the TGA can select any application for an audit, it mainly uses four risk-based criteria for its choices.
Understanding the Two Types of Audits
1. Mandatory Audits: Required for high-risk applications, such as:
2. Non-Mandatory Audits:
These are optional audits selected by the TGA. The new guidance offers detailed criteria for these audits, and currently, there is no fee for them.
Four Key Criteria for Non-Mandatory Audits
The guidance also provides tips to avoid delays:
Final Thought
The new TGA guidance offers insight into what regulators prioritize. By understanding these audit selection criteria, sponsors can be better prepared, submit stronger applications, and potentially reduce the chance of an audit.
To read more visit
Singapore Updates
A New Era for MedTech: Malaysia and Singapore Start a New Regulatory Pilot Program
In a major development for medical devices in Southeast Asia, Malaysia and Singapore are working together. On August 22, 2025, the Medical Device Authority (MDA) of Malaysia and the Health Sciences Authority (HSA) of Singapore signed an important agreement and launched a new Medical Device Regulatory Reliance Pilot Program.
This partnership, announced at a meeting in Cambodia, aims to harmonize regulations and speed up access to new medical technologies for patients.
What is the Regulatory Reliance Pilot?
This six-month pilot, starting from September 1, 2025, to February 28, 2026, will simplify the registration process for Class B, C, and D medical devices (moderate to high-risk) in both countries.
The main idea is regulatory reliance. Instead of each authority doing separate reviews, they will use each other's assessments and approvals. This makes the process more efficient and collaborative.
Key Benefits for the MedTech Industry and Patients
This initiative brings three main advantages:
1. Faster Approvals:
By depending on each other's thorough assessments, the approval process will be much quicker.
2. Lower Costs and Less Duplication:
Companies won't have to go through two long review processes, reducing administrative burdens, costs, and time to market.
3. Quicker Patient Access:
Patients in both countries will get faster access to safe and innovative medical devices, improving healthcare.
What Can Companies Expect?
The pilot creates clear pathways for registration:
The Future of ASEAN MedTech Regulation
This pilot programme is just the beginning. MDA and HSA will use the next six months to test the new pathways, improve procedures, and gather feedback. The goal is to evaluate the program for a permanent implementation.
This initiative could serve as a model for other ASEAN countries, promoting broader regulatory collaborations and creating a more unified medtech market in Southeast Asia.
Interested parties can contact the relevant authorities for more information:
Malaysia Updates
Malaysia Joins the Medical Device Single Audit Program (MDSAP)
Malaysia has officially joined the Medical Device Single Audit Program (MDSAP), allowing manufacturers and Authorized Representatives to leverage MDSAP certificates and audit reports as part of their pre-market approval submissions with the Malaysian Medical Device Authority (MDA).
This is an important step for Malaysia, showing its commitment to becoming a trusted authority in regulating medical devices and creating faster access to the market.
Why this matters:
What’s Next for Manufacturers?
For manufacturer to enter the Malaysian market:
Final Thoughts
Malaysia's participation in MDSAP is more than just a regulatory change it indicates growing global trust in medical device oversight. For manufacturers, this means fewer hurdles, quicker approvals, and a clearer path to delivering life-saving technologies to patients around the world.
To read more visit
Malaysia's New CAB Verification Pathway: A Faster Route to Medical Device Registration
The Medical Device Authority (MDA) of Malaysia has taken a significant step to streamline medical device registration with the release of the second edition of its crucial guidance document: MDA/GD/0068 - Conformity Assessment Body (CAB) Guide for Conducting Conformity Assessment by Way of Verification.
This updated guide, effective September 2025, provides a clear and efficient framework for Conformity Assessment Bodies (CABs) to verify devices that have already been approved by recognized international regulators.
Scope and Applicability
This guidance applies to:
Key Highlights
1. Verification-Based Assessment
CABs may conduct conformity assessments by verifying existing approvals, rather than performing full technical file reviews. This applies to:
2. Regulatory Foundations
3. Defined Submission Types
The document clearly distinguishes between:
4.Updated Reporting Templates:
The templates for Conformity Assessment Reports (Appendices 3 & 5) have been refined, moving from simple yes/no answers to requiring a summary/conclusion for clinical assessments and adjusting post-market surveillance reporting requirements.
Final Thought
For manufacturers and importers, it offers a clear and efficient pathway to compliance especially for globally approved devices entering the ASEAN market.
To read more visitHong Kong Updates
MDACS TR-007: Cybersecurity & Compliance for Software Medical Devices in Hong Kong
Hong Kong’s Department of Health has updated Technical Reference TR-007 under the Medical Device Administrative Control System (MDACS)—providing essential guidance for Software in a Medical Device (SiMD) and Software as a Medical Device (SaMD).
Key Highlights from the 2025 Revision
Why It Matters
As software becomes central to diagnostics, therapeutics, and monitoring, TR-007 ensures that innovation is matched by accountability. Cybersecurity is now a design imperative not a post-market fix.
Final Thoughts
Hong Kong’s TR-007 is not just a technical guide; it shows that regulations in digital health are becoming more advanced. As software plays a key role in diagnosing, treating, and monitoring health, guidelines like TR-007 help ensure that new ideas are safe and reliable.
To read more visit
IMDRF Updates
Global Harmony in Action: Overview of the 2025 IMDRF Implementation Report
The International Medical Device Regulators Forum has published its 2025 Implementation Report [IMDRF/MC/N84/FINAL:2025 (Edition 2)] offering a clear understanding of how member authorities are adopting IMDRF technical documents across jurisdictions.
What’s in the Report?
The report contains:
These guidelines focus on important areas such as:
Why It Matters
This report helps manufacturers and consultants map regulatory alignment across markets which is essential for global submissions, SaMD strategies, and post-market surveillance planning.
Conclusion
The 2025 IMDRF Implementation Report shows a clear trend: global regulatory convergence is actively happening. While achieving full harmony is complex, the report highlights significant progress and a strong commitment from regulatory bodies to work together. This spirit of collaboration is vital for fostering innovation while ensuring medical devices are safe and effective across the globe.
For more details, you can view the full report on the IMDRF website.
ISO Updates
ISO 22002-1:2025 — Improving Food Safety Standards
In July 2025, the food industry got an important update with the release of ISO 22002-1:2025. This is the first official version of the standard for Prerequisite Programmes (PRPs) in food manufacturing. It represents a big step forward from the earlier ISO/TS 22002-1:2009, updating food safety practices to meet today's risks and technologies.
What Is ISO 22002-1:2025?
ISO 22002-1:2025 outlines the requirements for creating, implementing, and maintaining PRPs to control food safety hazards in food manufacturing. It works alongside ISO 22002-100:2025, which standardizes PRPs across different sectors.
What’s New?
The 2025 edition introduces several improvements:
Part of a Unified Series
Together, these standards create a consistent framework for food safety throughout the entire supply chain.
Why It Matters
For manufacturers, ISO 22002-1:2025 is more than just a set of rules it’s a strategic guide that supports:
An Overview of The Draft International Standard (DIS) for ISO 9001:2026 and Its Impact
The release of the Draft International Standard (DIS) for ISO 9001:2026 is more than just a procedural milestone it’s a clear signal that the future of Quality Management Systems (QMS) is here.
Key Updates in ISO 9001:2026
1. Greater Risk-Based Thinking:
The distinction between risks and opportunities is now clearer. Organizations will need to show more intentional and integrated strategies for identifying and managing risks, ensuring that risk-based thinking is part of all processes and decisions.
2. Integration of Digital Transformation:
With advancements in AI, automation, and data analytics, digital tools are reshaping quality management. The new standard highlights:
3. xpanding Quality Focus: ESG and Climate Impact
Focus on sustainability and ESG Considerations related to climate change and Environmental, Social, and Governance (ESG) factors are now explicitly included in quality management.
4. Improved supply chain management:
The update sets clearer expectations for improving the entire supply chain, helping organizations create more robust, transparent, and ethically sound sourcing practices.
5. Leadership and quality culture:
There is renewed focus on the importance of leadership in fostering a culture of quality and ethical behavior. This includes encouraging continuous improvement, integrity, and a commitment to quality across the organization.
Important Dates
Final thought: For those already certified, the transition should be smooth. The organisation must:
ISO Update - September 2025
The September 2025 edition of the ISO Update provides an overview of important developments in global standards for the medical device industry. This report covers activities from August 1 to September 1, 2025, highlighting new drafts, changes, and confirmations that indicate future international regulatory focuses.
Contents of the Update
The ISO Update includes:
These stages represent the process of developing standards, from initial ideas to final approval and global use.
Key Standards to Watch
This technical specification provides guidance on managing risks for AI-based medical devices, explaining how to apply ISO 14971- Part 2: principles to machine learning.
A significant step toward ensuring AI safety worldwide.
Final Thoughts
ISO standards are not just technical documents; they are vital tools for global cooperation, innovation, and patient safety. The September 2025 update shows a regulatory environment that is increasingly digital, and data focused. For manufacturers, consultants, and regulatory bodies, keeping up with these changes is crucial for compliance, anticipating shifts, and aligning with global best practices.
South Africa Updates
SAHPRA's ISO 13485: Now a Prerequisite for Medical Device Establishment Licensing
The South African Health Products Regulatory Authority (SAHPRA) has issued a new requirement. ISO 13485 certificate is now necessary to get a Medical Device Establishment License (MDEL). If a business makes, imports, or sells medical devices or IVDs in South Africa, this guide outlines the required action and important deadlines .
Key Dates
Importance
Conclusion:
SAHPRA has completed its awareness phase, and the enforcement schedule is now active, starting with license renewals. Integrating a certified QMS into the operations is essential for market access.
Manufacturer must use this timeline to determine which phase their company is in and take the necessary steps to secure their ISO 13485 certification well before their deadline.
To read more visit
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.
