UK Updates

UK’s 2025 Roadmap to Phase Out Animal Testing

UK’s 2025 Roadmap to Phase Out Animal Testing

On November 11, 2025, the UK government announced a big plan to stop using animals for testing in science. With £75 million in funding and advice from experts, this roadmap sets out goals and timelines to use new human-focused methods instead.

Key Highlights

  • Using human cells in organ-on-a-chip systems
  • AI to predict molecular safety
  • 3D bio printed tissues for toxicity testing

Timeline

  • Stop animal testing for skin and eye irritation by 2026
  • End botox potency testing on mice and shift to DNA- based methods by 20
  • Reduce studies on dogs and primates by 2030

Infrastructure & Support:

  • Create a hub for preclinical models
  • Set up the UK Centre for Validation of Alternative Methods
  • Invest £15.9 million in developing human disease models ( liver, brain, cancer, blood vessels, pain)

Impact on Stakeholders

  • Regulations: Prepare for new rules and validation processes.
  • Review: Check which tests can be replaced with new methods.
  • Ethics: Align with public and ethical standards by using non-animal methods.
  • Training: Educate researchers and clients for the transition.

Strategic for manufacturers

  • Analyse gaps between current and new testing methods
  • Align documents with UK standards
  • Prepare for regulatory changes
  • Develop training for researchers and teams
Final Thought

This strategy is a key moment for UK science, promoting innovation and ethics and keeping regulatory clarity. By focusing on alternatives and streamlining approval pathways, the UK aims to lead in humane, high-quality research.

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MHRA Guidance Update Version 11.1 (October 2025): New Rules for Medical Device Clinical Investigation in the UK

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its rules for clinical trials of medical devices in the UK. The new Version 11.1 focuses on making rules clearer and easier to follow after Brexit, covering trials across Great Britain (GB) and Northern Ireland (NI).

Key Points

  • Great Britain follows the UK MDR 2002 rules, while Northern Ireland still follows the EU MDR 2017/745 because of the NI Protocol.
  • One submission to MHRA under EU MDR can cover trial sites in GB and NI.
  • MHRA says devices that follow EU MDR rules can be used in GB trials too.
  • New easy-to-follow charts show when trials are needed and what papers to send in.
  • For GB trials, manufacturer must notify MHRA 60 days before starting. For NI studies a 45 days authorisation period and MHRA must issue formal approval.
  • Extra 20 days allowed in some cases for external review.

Strategic Considerations for Sponsors

  • Check if the device needs a clinical trial based on its type and use.
  • Prepare all documents following UK and EU rules.
  • Remember the responsibilities as a sponsor or UK Responsible Person (UKRP).
  • Use the MHRA charts to guide trial setup, including special cases like prototypes or humanitarian use.
Final Thoughts

MHRA’s Version 11.1 guidance is an update that simplifies clinical investigation planning while reinforcing regulatory requirements. For manufacturers targeting the UK market, this is an opportunity to streamline submissions, clarify sponsor responsibilities, and ensure compliance with evolving expectations. To read more visit

At Sushvin Consultancy we provide guidance from designing the trial protocol for making regulatory submissions. Visit us for the guidance

European Updates

EU Releases Manufacturer’s Trend Report Form (MTR) – Version 1.0

Commission Decision (EU) 2025/2371

On November 26, 2025, the European Commission adopted Decision (EU) 2025/2371 and confirmed that important electronic systems in the European Database on Medical Devices (EUDAMED) are fully operational. This was published in the Official Journal on November 27, 2025, and is a significant step in the EU's medical device regulations under MDR (2017/745) and IVDR (2017/746).

Systems declared functional

The Commission, after an independent audit, confirmed that the following EUDAMED modules meet their functional specifications:

  • Actors → Registration of economic operators.
  • UDI & Devices → Unique Device Identification database and device registration.
  • Notified Bodies & Certificates → Oversight of conformity assessment and certification.
  • Market Surveillance → Reporting and monitoring of safety issues.

Importance

This decision starts the transition periods for using these systems. In practice, this means:

  • Mandatory use of EUDAMED starts for new devices on May 28, 2026.
  • Manufacturers, notified bodies, and regulators need to prepare to rely on EUDAMED for registration, certification, and surveillance.
  • There will be more transparency and traceability in the EU medical device market.

Industry Implications

  • Manufacturers must ensure timely registration of devices and economic operators in EUDAMED.
  • Need to ensure UDI data quality and completeness to avoid compliance gaps.
  • Should prepare internal systems for data uploads, updates, and monitoring.
Conclusion

Commission Decision (EU) 2025/2371 marks the official start of EUDAMED's operational phase. With mandatory use starting in May 2026, stakeholders must integrate EUDAMED into their compliance strategies. Manufacturers and regulatory professionals should audit their data, align their processes, and prepare for full digital compliance in the EU medical device market.
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EUDAMED Gradual Roll-Out

The European Commission has announced the roll-out of EUDAMED (European Database for Medical Devices) on Medical Device Regulation under the MDR (2017/745) and IVDR (2017/746). A new decision (EU) 2025/2371 was published in the Official Journal on 27 November 2025, under this several important modules are declared functional and hence generated a timeline for compliance.

This means the industry is entering a new phase for EUDAMED, where each module will become mandatory six months after it's announced as functional in the Official Journal of the European Union (OJEU).

Regulation (EU) 2024/1860

The amendment to MDR and IVDR include three main points:

  • Gradual roll-out of EUDAMED→ Each module becomes mandatory once audited and confirmed functional.
  • Notification requirement→ Manufacturers must inform competent authorities about any supply issue such as interruptions or discontinuations.
  • Transitional provisions for IVDs → extended timelines for conformity assessments to avoid shortages.

Modules Declared Functional (Nov 2025)

  • Actors (ACT) – registration of manufacturers, importers, authorized representatives, and others.
  • UDI/Devices (UDI/DEV)– register devices with their Unique Device Identifier (UDI).
  • Notified Bodies & Certificates (NB/CRF)– register certificates, establish a review process, and other related documents.
  • Market Surveillance (MSU) – report and monitor by authorities.

Upcoming Modules

  • Post-Market Surveillance & Vigilance (VGL) → expected announcement in Q4 2026, with mandatory use starting in Q2 2027.
  • Clinical Investigations/Performance Studies (CI/PS) → to be mandated six months after the OJEU notice confirming it works (date to be decided).

Key Dates to Remember

  • 27 Nov 2025 → Publication of Commission Decision in the Official Journal
  • 28 May 2026 → Mandatory use begins for Actors, UDI/Devices, Notified Bodies & Certificates, and Market Surveillance modules
  • 26 Nov 2026 → Full device registration deadline (including legacy devices)
  • Q4 2026→ Vigilance module notice expected (subject to audit)
  • Q2 2027 → Vigilance module mandatory use
  • 27 May 2027 → Notified Bodies must upload all certificate information

Industry Implications

Manufacturers need to register actors and devices, prepare UDI information, and set up vigilance reporting systems.

Conclusion

The gradual roll-out of EUDAMED brings a new era of transparency and accountability in EU medical device regulation. With mandatory use starting in May 2026, it's crucial for all parties to begin preparing now to integrate EUDAMED into their compliance processes for smooth transition and continued access to the market.

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MedTech Europe Advocates Risk-Based PMCF

MedTech Europe has released a compelling position paper urging the European Commission and Medical Device Coordination Group (MDCG) to adopt a more pragmatic, risk-based approach to Post-Market Clinical Follow-up (PMCF) especially for low-risk devices with well-established safety profiles.

This call comes amid growing concerns from manufacturers, healthcare professionals (HCPs), and patients about the disproportionate burden of PMCF clinical investigations under the Medical Device Regulation (EU) 2017/745 (MDR).

The Issue

Regulators and Notified Bodies often expect a PMCF clinical study as the standard option, overlooking two key principles:

  • Proportionality: PMCF activities should fit the device's purpose and risk. A low-risk device with a long history of safe use shouldn't be treated the same as a new, high-risk device.
  • Pragmatism: Requesting data for every small variant of a device is often unrealistic.

Impact on Healthcare and Patients

  • Healthcare Professionals: Overloaded with PMCF study requests, reducing focus on patient care.
  • Patients: Exposed to unnecessary risks, such as terminally ill patients being asked to provide feedback on non-beneficial devices.
  • Innovation: Resources for PMCF studies could be better used to develop new devices.

Case Studies

The MedTech Europe paper provides clear examples:

  • Case 1: A long-standing intubation device was required to undergo a new PMCF study, which hasn't progressed in five years due to lack of interest.
  • Case 2: A low-risk guidewire needed a separate investigation, despite existing safety data.
  • Case 3: Feedback was requested from terminally ill patients, showing a lack of ethical consideration.

Risk-Based Solution

The MDR supports a risk-based approach. MedTech Europe suggests:

  • Consistent Guidance: Authorities should apply guidance consistently, indicating that lower-risk devices might not need new clinical studies.
  • Clear PMCF Definition: The MDR should clearly distinguish between full clinical investigations and other valid methods like surveys or real-world data.
  • Use Existing Data: Emphasize using existing data and evidence to demonstrate ongoing safety.
  • Focus on High-Risk Areas: Target PMCF efforts on higher-risk variants or where safety concerns exist.
Conclusion

The MDR aims to ensure patient safety, but a one-size-fits-all approach is counterproductive. It burdens professionals, inconveniences patients, hinder innovation, and threatens the availability of safe devices. By adopting a risk-based, practical approach, we can protect patients and focus resources where they are most needed.

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TUV SUD’s MRI Safety Testing for Implantable Medical Devices

As magnetic resonance imaging (MRI) becomes increasingly important to diagnostics, the safety of implantable medical devices in MRI environments has emerged as a critical concern. Implantable devices face serious risks in MRI settings such as heating, displacement, and image distortion which can compromise both patient safety and diagnostic accuracy. TÜV SÜD now offers comprehensive MRI Safety Testing to help manufacturers meet global regulatory expectations with confidence.

Why MRI Safety Testing Matters

Implantable devices such as pacemakers, neurostimulators, and orthopedic implants can interact dangerously with MRI scanners due to:

  • Magnetic forces
  • Induced heating
  • Gradient field effects
  • Image distortion

These risks can have a drastic effect on patient safety and device performance. Regulatory bodies like the FDA and EU MDR now require rigorous testing and clear labelling for devices intended for use near MRI systems

TUV SUD’s Testing Capabilities

TUV SUD’s MRI Safety Testing includes:
  • Displacement force and torque testing per ASTM F2052
  • RF heating evaluation per ASTM F2182
  • Image artifact analysis per ASTM F2119
  • Assessment of device labelling and conditional use scenarios
  • Support for technical documentation and regulatory submissions
Regulatory Alignment

TÜV SÜD’s testing protocols align with:

  • EU MDR and IVDR requirements
  • FDA guidance on MRI safety labelling
  • ASTM and ISO standards for implantable devices
  • IEC 60601 series for electromagnetic compatibility

Strategic for manufacturers

  • Integrate MRI safety into early-stage device design
  • Prepare audit-ready technical documentation
  • Map ASTM and ISO test results to regulatory requirements
  • Develop MR Conditional labelling strategies for global markets
Final Thought

MRI compatibility is no longer optional it’s a regulatory requirement and clinical very important. TÜV SÜD’s MRI Safety Testing empowers manufacturers to validate their devices, protect patients, and accelerate market access with confidence.

At Sushvin Consultancy, we stand ready to guide you through every step of the MRI safety journey from risk assessment to regulatory submission.
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Digital Labelling for Authorised Representative and Importer

In October 2025, four leading European trade associations MedTech Europe, AESGP, COCIR, and Euromcontact published a joint position paper suggesting the European Commission to allow digital labelling of Authorised Representative (AR) and Importer information under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

This proposal supports the idea that regulations should become more efficient, sustainable, and adaptable.

Why Digital Labeling?

Under MDR Annex I (GSPR 23.2, 23.3) and IVDR Annex I (GSPR 20.2), manufacturers are required to include both essential and additional information such as AR and Importer details on the physical label of the device.

The position paper argues that:

  • AR and Importer details are non-essential for safe use
  • Frequent changes in distribution networks make static labelling inefficient
  • Digital formats (e.g., QR codes, data carriers) offer real-time updates without disrupting supply chains

Benefits of Digital Labelling

For Manufacturers:
  • Simplified label management across EU markets
  • Reduced regulatory resistance during distribution changes
  • Lower environmental impact and packaging costs
For Patients and Users:
  • Continued access to safety-critical information
  • Enhanced transparency through digital access

Strategic Implications for Stakeholders

  • Evaluating digital infrastructure readiness for label transformation
  • Preparing for hybrid labelling strategies combining physical and digital formats
  • Engaging with notified bodies and competent authorities to align on digital label adoption
Final Thought

This joint industry proposal is more than a technical adjustment it’s a strategic shift toward modernized, responsive, and eco-conscious compliance. By embracing digital labelling for AR and Importer information, the EU can reduce administrative burden, enhance market agility, and support environmental goals without compromising patient safety.

At Sushvin Consultancy, we continue to monitor regulatory developments to help clients stay ahead of the changes.
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Australian Updates

Australia's TGA to Accept UKCA Certification from December 2025

Australia's TGA to Accept UKCA Certification from December 2025

On 30 October 2025, the Australian Government published the Therapeutic Goods (Overseas Regulators) Amendment Determination 2025, marking a crucial shift in the country’s medical device regulatory framework. Starting December 1, 2025, Australia's Therapeutic Goods Administration (TGA) will start accepting UKCA certification from UK Approved Bodies. This change is part of its Comparable Overseas Regulator (COR) framework. This broader effort is to streamline the process for medical devices to be registered in Australia.

Key Points:

  • UKCA certification will be accepted for medical devices and in vitro diagnostics (IVDs) above Class I.
  • UK Approved Bodies will now be listed along with other regulators like the FDA and EU Notified Bodies.
  • Updates to TBS code tables.

Benefits for Manufacturers:

Manufacturers need to show:

  • Expanded Market Access: UKCA-certified sponsors can now apply more easily for registration in Australia, speeding up market entry.
  • Efficiency: The TGA will use assessments from trusted overseas regulators to simplify evaluations which will improve efficiency.
  • Global Strategy Alignment: This aligns with the UK's independent regulatory framework while supporting global standards.
Conclusion:

Accepting UKCA certification shows Australia’s commitment to global regulatory cooperation. This change offers a valuable opportunity for manufacturers with UK approvals to expand into the Australian market more smoothly.

Sushvin Consultancy is here to help navigate this new landscape with ease. We assist manufacturer with:

  • Mapping UKCA evidence to TGA requirements
  • Preparing submissions for Australia
  • Aligning global strategies across regions

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TGA Australia Updates Guidance on Essential Principles on the safety and performance of Medical Devices

On November 20, 2025, the Therapeutic Goods Administration (TGA) revised its guidance document: Complying with the Essential Principles on the safety and performance of medical devices. Initially published in August 2022, this guidance details the legislative requirements that medical devices must fulfill before being supplied in Australia.

This update emphasizes evidence-based compliance and alignment with global standards, ensuring that medical devices continue to meet safety, quality, and performance expectations throughout their lifecycle.

Key Highlights:

  • This applies to all medical devices and IVDs supplied in Australia
  • Manufacturers must hold scientific & technical evidence of compliance before supply
  • Sponsors must hold or be able to obtain this evidence within a reasonable timeframe
  • Supplying, importing, or exporting non-compliant devices is an offence under the Therapeutic Goods Act 1989 (Part 4-11)
  • Emphasizes documentation readiness and traceability across the supply chain.

Importance of November 2025 Update

The update reflects TGA’s ongoing efforts to:

  • Align with international frameworks like EU MDR Essential Requirements and FDA QMSR.
  • Strengthen post-market surveillance and vigilance systems.
  • Ensure timely access to compliance evidence during regulatory reviews.

For manufacturers and sponsors, this means revisiting compliance systems to ensure they are robust, transparent, and audit-ready.

Conclusion

The November 2025 update to TGA’s Essential Principles guidance is more than a routine revision it’s a reminder that compliance is a continuous responsibility. Manufacturers and sponsors must ensure that their documentation, vigilance systems, and quality frameworks align with Australian law and evolving global standards.

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Egypt Updates

Egypt Issues New Guideline for Medical Device Vigilance System 2025

Egypt Issues New Guideline for Medical Device Vigilance System 2025

Introduction

In November 2025, the Egyptian Drug Authority (EDA) published the first version of the Egyptian Guideline for Medical Device Vigilance System 2025. This important landmark document establishes a robust system to monitor medical devices in Egypt, aligning with international standards while meeting local needs.

    Objectives

  • Strengthen market surveillance and patient safety.
  • Ensure quick reporting of serious incidents.
  • Analyze trends to detect recurring issues.
  • Integrate vigilance with post-market surveillance and risk management systems.

Scope of the Guideline

  • Applies to all medical devices, including in vitro diagnostic devices.
  • Includes both pre-market and post-market vigilance requirements.
  • Aims to ensure safety, quality, and performance throughout the device's life.
  • stakeholders, and ensures compliance.

Manufacturer Responsibilities

  • Set up a vigilance system as part of the quality management system.
  • Report serious incidents and device issues to the EDA's Medical Device Safety Unit (MDSU) within required timeline.
  • Investigate root causes and take corrective and preventive actions (CAPA).
  • Keep documentation showing compliance with safety and performance standards.
  • Analyze trends to identify recurring issues and update risk management files.
  • Work with users and regulators to ensure clear and timely communication of safety information.

User (Healthcare Institutions/Professionals) Responsibilities

  • Quickly report adverse events and device issues to manufacturers or the MDSU.
  • Provide complete and accurate information about incidents to support investigations.
  • Cooperate with manufacturers during root cause analysis and CAPA implementation.
  • Use devices properly according to instructions and training to reduce misuse risks.

Medical Device Safety Unit (MDSU) Responsibilities

  • Serve as the central authority within the EDA for medical device vigilance.
  • Receive, evaluate, and monitor incident reports from manufacturers and users.
  • Work with stakeholders to ensure corrective actions are effective.
  • Conduct market surveillance to detect non-compliance and enforce regulations.
  • Maintain a national vigilance database for trend analysis and risk monitoring.
  • Issue guidance, alerts, and regulatory actions to protect public health.

Global Alignment

The framework follows international practices, particularly from the EU's MDR and IVDR, and the FDA's surveillance systems. This alignment shows Egypt's commitment to global standards, making compliance easier for global manufacturers.

Importance

  • Manufacturers need effective vigilance systems before entering the market.
  • Healthcare institutions require clear pathways for reporting adverse events.
  • Regulators gain better tools for oversight, enhancing patient safety and regulatory clarity.
Conclusion

The new guideline is a major advancement in Egypt's regulatory approach, harmonizing with global standards while addressing local needs. It offers regulatory professionals a chance to compare vigilance systems globally and prepare for increasing compliance demands.

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Team NB Updates

Understanding Changes in Companion Diagnostics

Understanding Changes in Companion Diagnostics

The European Association of Notified Bodies (TEAM-NB) has published Version 2 of its position paper interpreting Annex IX, section 5.2(f) of the In Vitro Diagnostic Regulation (IVDR) 2017/746. Adopted on 22 October this paper outlines when prior notified body approval is required for changes to companion diagnostic (CDx) devices.
This information is crucial for companies managing changes and updates to companion diagnostic products under the IVDR rules.

Scope and Purpose

The position paper provides guidance on how notified bodies assess changes to CDx devices that may affect:

  • Performance
  • Intended use
  • Suitability in relation to the associated medicinal product

It distinguishes between:

  • Initial consultations under IVDR Annex IX, Sections 5.2(c), (d), and (e)
  • Follow-up consultations under Section 5.2(f)

Manufacturers must decide if consulting a medicinal product authority is necessary for changes and justify if it's deemed unnecessary.

Key Scenarios

The paper categorizes changes into three groups:

1. Changes outside the scope of medicinal product authority consultation
These do not affect suitability and include:
  • Change in critical raw material or supplier
  • Platform transfer
  • Shelf-life extension
  • Reagent supplier change
  • Market expansion to new regions
2. Changes within the scope of the original consultation
These may require follow-up consultation and include:
  • Addition of new sample types
  • Expanded target patient population
  • Additional mutations with outcome data
  • Reagent format changes
3. Changes outside the original scope
These require a new initial consultation and include:
  • Medicinal product extension or restriction impacting CDx claim
  • New limitations (e.g., cross-reactivity)
  • Addition of new INNs to large panel NGS devices

A flowchart in guideline helps manufacturers determine the appropriate consultation pathway.

Implications for Legacy Devices

Legacy CDx devices under IVDR Article 110(3) are subject to the same restrictions on significant changes. Any change to design or intended purpose may result in loss of legacy status and require a full IVDR conformity assessment with notified body involvement and medicinal product authority consultation.

Final Thoughts

This guidance paper supports the IVDR’s emphasis on clinical relevance, traceability, and regulatory oversight for companion diagnostics. Manufacturers must treat CDx changes with the same importance as initial submissions, this will ensuring transparency, patient safety, and regulatory compliance.
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Switzerland Updates

Swissmedic Updates PSUR Guidance for Veterinary Medicinal Products

Swissmedic Updates PSUR Guidance for Veterinary Medicinal Products

On 1st November 2025, Swissmedic released version 2.0 of its guidance documents PSUR Signal Management TAM for safety reports on veterinary medicines. This guidance clarifies the regulatory expectations for Periodic Safety Update Reports and Signal Management Process for veterinary medicinal products.

What's New in version 2.0?

The new guidelines make it clear that:
  • Periodic Safety Update Reports (PSURs) and Signal Management
  • Process (SMP) reports have separate requirements.
  • EU SMP reports can't replace the detailed Swiss PSURs.
PSUR Requirements
  • New updates to ISO 10993 focus on risk-based testing for biocompatibility.
  • Committee Draft ISOCD TS 20324 advances extraction methods for toxicological risk assessment of medical devices.
PSURs should include:
  • Sales and adverse reaction data
  • Product details and safety evaluations
  • Risk assessments and any actions taken
SMP Reporting

Annual EU SMP reports alone aren't enough for Swissmedic’s PSUR requirements. Any significant changes in risk must be reported immediately to Swissmedic.

Advice for Companies
  • Follow Swiss-specific report formats for PSUR
  • Not to relying on EU SMP reports for Swissmedic compliance
  • Align pharmacovigilance documentation with VICH GL 29 and VGVP
  • Preparing accurate safety evaluations
  • Monitoring post- authorisation for changes that might affect reporting
Final Thoughts

Swissmedic's 2025 update to its guidelines on PSUR Signal Management highlights a stronger focus on keeping data accurate, improving safety monitoring, and being transparent in veterinary medicine regulations. By clearly differentiating between PSURs from EU SMP reports and emphasizing the importance of thorough safety checks, Swissmedic is raising the standards for monitoring products after they hit the market.

At Sushvin Consultancy, we help companies prepare these reports and navigate regulations effectively. For Full Guidance Visit Us

ISO Updates

ISO Medical Device Standards Update – November 2025

ISO Medical Device Standards Update – November 2025

The ISO Update (November 2025) highlights key changes in international standards for medical devices and technologies. These updates aim to enhance safety, performance, and regulatory alignment across the global healthcare industry.
Below is a summary of the medical device-specific standards currently in development.

Key Medical Device Standards in Development

1. Transfusion, Infusion, and Injection Equipment (TC 76)
  • ISO/CD 8871-1: Elastomeric parts for parenterals and pharmaceutical devices – Part 1: Extractables in aqueous autoclavates
    >> Focuses on chemical safety in drug delivery systems.
  • ISO/DIS 8536-5: Infusion equipment for medical use – Part 5: Burette infusion sets for single use, gravity feed (Revision of ISO 8536-5:2004)
    >> Updates requirements for single-use infusion sets to ensure performance and safety.
2. Devices for Administration of Medicinal Products (TC 84)
  • ISO/CD 10555-3: Intravascular catheters – Sterile and single-use catheters – Part 3: Central venous catheters
  • ISO/CD 10555-5: Intravascular catheters – Sterile and single-use catheters – Part 5: Over-needle peripheral catheters
3. Anaesthetic and Respiratory Equipment (TC 121)
  • ISO/CD 5359: Low-pressure hose assemblies for use with medical gases
  • ISO/CD 18082: Dimensions of non-interchangeable screw-threaded (NIST) connectors for medical gases
    >> Address safe connections and hose assemblies to reduce risks in clinical settings.
4. Dentistry (TC 106)
  • ISO/DIS 9693: Compatibility testing for metal-ceramic and ceramic-ceramic systems
    >> Ensures compatibility and durability of dental materials in prosthetics.
5. Medical Laboratories and In Vitro Diagnostics (TC 212)
  • ISO/CD 21474-4: Multiplex molecular testing for nucleic acids – Part 4: Detection of pathogens
  • ISO/CD 25379-1: Next Generation Sequencing (NGS) workflows – Part 1: Human DNA examination
  • ISO/CD 25379-2: Next Generation Sequencing (NGS) workflows – Part 2: Human RNA examination
    >> Enhance molecular diagnostics for accurate pathogen detection and genetic testing.
6. Medical Devices – In Silico Technologies (IEC/CD TR 63691-1)
  • Part 1: Terminology and context
    >> Establishes terminology for computer-based modelling and simulation in medical device development.
Conclusion

The November 2025 ISO Update showcases extensive work in medical device standardization. Developments in infusion equipment, catheters, diagnostics, and in silico technologies will shape compliance and patient safety globally.

For regulatory professionals and manufacturers, staying informed on these updates is essential for audit readiness, market access, and global alignment.

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India Updates

Navigating India's Medical Device Regulations: A Guide to the New Class A (Non-Sterile, Non-Measuring) List

Navigating India's Medical Device Regulations: A Guide to the New Class A (Non-Sterile, Non-Measuring) List

In a significant move to streamline the regulatory landscape for medical devices in India, the Central Drugs Standard Control Organisation (CDSCO) has published a comprehensive and dynamic list classifying over a thousand devices as Class A (non-sterile and non-measuring). This official list, issued under the Medical Devices Rules, 2017, provides much-needed clarity for manufacturers and importers.

What does this mean for manufacturers and importers?

According to the notice (F. No. MED-16014(12)/1/2024-eoffice-Part(2)), dated October 3, 2023, medical devices classified under this list are exempt from the licensing requirements of Medical Devices Rules, 2017.

Manufacturers or importers must get a registration number through the CDSCO Online System for Medical Devices under Chapter IIIB.

Key Considerations from the CDSCO Notice

The CDSCO has outlined important conditions that stakeholders must keep in mind:

  • Intended Use as Guidance:The general intended use provided for each device is for guidance. Manufacturers can specify a different intended use, provided it aligns with the general purpose mentioned in the CDSCO list.
  • A Dynamic List: The CDSCO has stated that the list is dynamic and subject to revision as per the provisions of the Medical Devices Rules.
  • Exclusion of Sterile/Measuring Variants: If the produce or version of a listed device is sterile or has a measuring function, it does not qualify for this Class A exemption and will likely fall into a higher risk class (B, C, or D), requiring a full license.
Conclusion

The publication of this extensive list is a welcome step towards transparency and ease of doing business in the Indian medical device sector. For innovators and suppliers of low-risk devices, it reduces the regulatory burden, allowing them to focus on quality and availability. For manufacturer or importer, the immediate action should be to cross-reference the product portfolio with this list. If the device is included, the manufacturer can proceed with the simpler registration process on the CDSCO portal.

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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.

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