UK Updates

UK International Recognition Framework for Medical Devices — April 2026 Policy Update

United Kingdom Medical Device Registration: A Practical Guide for Manufacturers and Importers

Last updated 10 April 2026

The Medicines and Healthcare products Regulatory Agency (MHRA) has revised its guidance on registering medical devices for the UK market. The update includes important changes that manufacturers, importers, and UK Responsible Persons (UKRPs) are required to follow.

Key highlights

  • All medical devices including IVDs, custom made devices, and system/procedure packs must be registered with the MHRA before they are placed in the Great Britain market.
  • Registration is a legal requirement, not an approval or certification and manufacturers cannot claim MHRA endorsement of a product’s safety or performance.
  • Non UK manufacturers must appoint a UK Responsible Person (UKRP) to manage regulatory obligations.
  • From 1 April 2026, a new annual fee structure applies, based on the number of GMDN® categories registered.
  • For Northern Ireland from 28 May 2026, registration will be shifted to EUDAMED, with custom made devices remaining under MHRA oversight.

New Annual Fee Structure

From 1 April 2026, the MHRA introduced a new annual fee structure, replacing the previous one. Now manufacturers are required to pay annually based on the number of Level 2 GMDN® categories under which their devices are registered. From 1 April 2026 to 31 March 2027, the unit cost is £300 per category per year, charged on a pro rata basis where applicable.

Information Required

Manufacturers must provide:

  • Legal entity details, designation letters for UKRPs, and written mandates for NI Authorised Representatives.
  • Device classification, GMDN® code, Basic UDI DI (if applicable), conformity certificates, and product attributes.

Conclusion

The April 2026 MHRA guidance on medical device registration highlights the MHRA's commitment to strong regulatory oversight, transparency, and alignment with changing EU regulation. By introducing annual fee structures, stricter UK Responsible Person requirements, and clearer rules for Great Britain and Northern Ireland markets, the MHRA is making manufacturer accountable and prioritizing patient safety.

For manufacturers and importers, particularly those based outside the UK, early planning and appointing a capable UK Responsible Person are essential for market access.

Sushvin Provides UK Responsible Person (UK RP) Services

For more information visit : https://lnkd.in/ghhvbEec

Understanding the MHRA’s New Device Registration Fee Structure (April 2026)

The Medicines and Healthcare products Regulatory Agency (MHRA) has introduced a new annual fee structure for medical device registrations, effective 1 April 2026. This marks a significant shift from the previous one off application fees, aligning with strengthened post market surveillance legislation and the UK’s evolving regulatory framework.

The new fee system supports:

  • Enhanced patient safety through improved surveillance and faster response to safety signals.
  • Innovation by creating a more risk proportionate regulatory environment.
  • Sustainable funding for ongoing regulatory activities.

This change follows the public consultation (Aug–Oct 2024) and reflects commitments under the Medicines and Medical Devices Act 2021.

Key Changes

  • Annual fee replaces one off application fees.
  • No separate charges for uploading Letters of Designation or updating organisation details.
  • No waivers or SME discounts – fees are based on cost recovery principles.
  • Updates to organisation name and/or address: From 1 April 2026, fee is not needed to update organisation’s name or address

New Fees Structure

The annual fee is linked to Global Medical Device Nomenclature (GMDN®) Level 2 Categories:

  • Single charge per GMDN® Code even if it appears in multiple categories.
  • Minimised charges – MHRA ensures you pay for the fewest possible GMDN categories.
  • Pro rata fees apply when registering new devices mid year.
  • Level 1 Categories – where no Level 2 exists, a single fee covers all devices in that category.

If the annual fee is £300, registering four categories on 2 April (364 days left in the charging period) results in a total payable of £1196.70.

Account Management Essentials

  • Review registrations annually by 31 March – fees are calculated on 1 April based on active devices.
  • Unregister obsolete devices to avoid unnecessary charges.
  • Suspended accounts cannot place devices on the UK market and will not appear on the Public Access Registration Database (PARD).

Northern Ireland Considerations

From 28 May 2026, non custom made devices must be registered in EUDAMED.

  • MHRA fees will apply only to custom made devices.
  • Voluntary registration of non custom made devices remains possible, with fees payable.
  • From 1 April 2027, full fees apply to both custom made and voluntarily registered devices.

Importance

For manufacturers, UK Responsible Persons (UKRPs), and Authorised Representatives, this new fee structure is more than just an administrative update. It reflects the UK’s commitment to robust post market surveillance, patient safety, and innovation support.

To read more visit : Register medical devices to place on the market - GOV.UK

Clinical Investigations in Great Britain: MHRA’s 2026 Guidance

The Medicines and Healthcare products Regulatory Agency (MHRA) has published updated guidance on how manufacturers should perform clinical investigations for medical devices in Great Britain. This guidance clarifies when investigations are required, how to notify the MHRA, and the required standards manufacturers must meet to ensure compliance with the UK Medical Devices Regulations (UK MDR).

Requirement

Manufacturers must notify the MHRA if they plan to use a non UKCA or non CE marked device on human participants. Investigations are required for:

  • Implantable or Class III devices.
  • Devices introducing new concepts
  • Devices incorporating new materials or used in new anatomical locations.
  • Existing devices redesigned for new functions.

Notifying the MHRA

  • Manufacturers or UK Responsible Persons must provide 60 days’ prior notice before a device is made available for clinical investigation.
  • Applications are submitted via the Integrated Research Application System (IRAS) portal.
  • If MHRA raises no objection within 60 days, the investigation may proceed.
  • Ethics committee approval is also required before starting any investigation.

Complying with Requirements

Clinical investigations must demonstrate that:

  • The device performs as intended under normal conditions of use.
  • Risks are acceptable when weighed against expected benefits.
  • Adverse events are fully recorded, with serious events reported to MHRA.
  • It follow’s BS EN ISO 14155:2020 Good Clinical Practice .

Special Circumstances

  • Comparative studies: Notification required if one device lacks UKCA/CE marking.
  • Prototype devices: Variations allowed within one application unless risks increase.
  • Off label use: Clinicians may assume manufacturer responsibilities if pursuing commercial applications.
  • Humanitarian use: MHRA may authorise non UKCA/CE devices for individual patients in exceptional cases.

Other Factors to Consider

  • Number of devices: Sufficient to demonstrate performance
  • Duration: Long enough to identify short term risks, with post market follow up for long term safety.
  • Labelling: Devices must be marked exclusively for clinical investigation.
  • Research ethics committee opinions: Mandatory before starting investigations.

Communication and Reporting

Manufacturers must notify MHRA of:

  • Amendments or modifications to investigations.
  • Final clinical investigation reports (within one year of completion).
  • Early termination or temporary halts, with justification.
  • All serious adverse events.

For guidance visit https://lnkd.in/ghhvbEec

European Updates

EU Artificial Intelligence Act — March 2026 Implementing Regulation

MDCG 2021 24 Rev.1: Updated EU Medical Device Classification Guidance

In April 2026, the Medical Device Coordination Group (MDCG) published MDCG 2021 24 Rev.1, an updated version of its guidance on medical device classification.

Core purpose and scope

MDCG 2021 24 Rev.1 is an endorsed MDCG guidance document intended to support consistent application of MDR Annex VIII classification rules across Member States. Although it is not legally binding, it influential in notified body assessments and regulatory inspections.

Importance

The revised guidance reflects several years of MDR enforcement realities. Especially for:

  • substance-based devices
  • software and digital health tools
  • implantable and surgically invasive accessories
  • nanomaterial-containing devices
  • systems and procedure packs

MDCG 2021 24 Rev.1 responds by refining definitions, restructuring explanations, and expanding practical issues of classification.

Key Horizontal clarifications Introduced in Rev.1

1. . Classification Is Driven by Intended Purpose—Not Accidental Use

The guidance strongly reiterates that classification is determined solely by the manufacturer’s intended medical purpose, not by misuse or evolving off label clinical practice.

2. The Strictest Rule Always Applies Principle Is Reinforced

If multiple classification rules or sub rules apply, the strictest rule resulting in the highest class prevails.

Important rule-specific highlights

  • Software Classification (Rule 11): Rev.1 discourages under-classifying software that drives decisions or influences diagnosis/therapy and aligns with MDCG 2019-11.
  • Substance-based devices (Rule 21): classification depends on site of action and absorption. Systemic absorption - Class III; local action in skin/oral/nasal cavity (Class IIa); other cases - Class IIb. Manufacturers must justify mode of action and where the intended purpose is achieved.
  • Nanomaterials (Rule 19): Rev.1 significantly strengthens expectations around nanomaterial classification. Devices with medium or high internal exposure potential default to Class III

Systems and Procedure Packs

The guidance clarifies that:

  • classification depends on the intended purpose of the final system
  • if purpose is unclear, the highest class component drives classification
  • where CE marked components are improperly combined, the integrator assumes full manufacturer obligations.

Task for manufacturers

  • Re-review existing classifications against Rev.1
  • Update Annex II technical documentation and justifications
  • Reassess clinical evidence and post-market surveillance for devices trending changes
  • Engage notified bodies early, especially for Rule 11, 19, and 21 devices

Conclusion

MDCG 2021 24 Rev.1 tightens interpretation of Annex VIII, reduces flexibility, and expects classification to match real-world clinical impact. It doesn’t change the law it materially influences its application. It reduces interpretational flexibility, reduces classification loopholes, and reflects regulators expectation.

For guidance visit: https://lnkd.in/ghhvbEec

Regulatory Alert: MIR Form v7.3.1 Mandatory from 1 May 2026

The updated Manufacturer Incident Report (MIR) Form version 7.3.1 becomes mandatory for all manufacturers and authorized representatives starting 1 May 2026. This update is part of EU MDR/IVDR vigilance requirements and requires companies to align their incident reporting processes, IT systems, and post market surveillance workflows with the new format.

Changed in the MIR Form

  • Version 7.3.1 replaces earlier versions and must be used for all serious incident reporting under MDR and IVDR.
  • Minor layout changes and clearer help text to make drafting easier.
  • Technical updates with new XML/XSD structures for database integration, ensuring smoother electronic submissions.
  • Alignment with PMS guidance reinforces the link between vigilance reporting and broader post market surveillance obligations.

Key Dates

  • Published: December 2025 (final revision).
  • Mandatory use: Friday, 1 May 2026.

What Manufacturers & UKRPs Need to Do

  • Update vigilance procedures so incident reporting follows MIR 7.3.1 requirements.
  • Train teams: regulatory, QA, and vigilance staff must be familiar with the new format.
  • Adapt IT systems: integrate XML/XSD files into databases for automated reporting.
  • Check PMS processes: harmonize incident reporting with ongoing surveillance activities.
  • Coordinate with Authorized Representatives to ensure EU and UK reporting obligations are consistently met.

Practical Tips

  • Download the MIR 7.3.1 PDF and save locally before use.
  • Use Adobe Acrobat Professional for signing and XML data import/export.
  • Request passwords from the European Commission if needed for translation or system integration.

Final thought:

All manufacturers and UK Responsible Persons must switch to MIR Form 7.3.1 by 1 May 2026. Start updating vigilance procedures, IT systems, and staff training now to ensure seamless compliance and avoid regulatory disruption.

To read more visit : https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance/pmsv-reporting-forms_en

IMDRF Updates

Governing AI in Healthcare: IMDRF’s Technical Framework for AI Life Cycle Management

Governing AI in Healthcare: IMDRF’s Technical Framework for AI Life Cycle Management

The International Medical Device Regulators Forum’s (IMDRF) AI/ML-enabled Working Group has released a draft document (IMDRF/AIML WG/N88 FINAL: 2025) titled: Technical Framework for Artificial Intelligence Life Cycle Management.

Importance

AI enabled medical devices differ fundamentally from traditional medical software. They learn from data, may adapt over time, and interact deeply with human decision making.

The purpose of this document is to:

  • Provide foundational information on AI-enabled medical device life cycle management;
  • Highlight universal concepts applicable to all life cycle steps;
  • Provide an overview of concepts and considerations for each step of the AI-enabled medical device life cycle; and
  • Provide references to applicable, internationally-recognized standards and resources.

Universal Concepts Across the AI Life Cycle

The framework establishes four universal pillars applicable to every phase of the AI life cycle:

1. Quality Management Systems (QMS)

AI enabled medical devices must be governed by robust QMS frameworks (such as ISO 13485), ensuring traceability of data, model versions, and performance monitoring.

2. Risk Management

While grounded in traditional medical device risk frameworks (ISO 14971), AI introduces unique risks:

  • Biased training data
  • Loss of performance due to real world data drift
  • Over or under reliance by clinicians

3. Human Oversight

Human oversight is essential in design, validation, deployment, and monitoring to prevent automation bias and to ensure safe human AI collaboration.

4. Cybersecurity

AI medical devices are particularly exposed to cybersecurity threats. The framework calls for continuous monitoring.

The Eight-Step AI Enabled Medical Device Life Cycle

At the heart of the framework is an eight stage life cycle model, reflecting AI’s dynamic and evolving nature.

1. Planning and Design

  • Clear definition of intended use
  • Multidisciplinary collaboration
  • Early decisions on whether AI is appropriate at all

2. Data Collection and Management

The framework addresses:

  • Bias mitigation
  • Use of synthetic or augmented data
  • Documentation of data lineage and provenance

3. Model Building and Tuning

Developers are encouraged to balance:

  • Performance vs. explainability
  • Complexity vs. clinical relevance

4. Verification and Validation (Including Clinical Evaluation)

  • Generalizability across populations
  • Realistic clinical workflows
  • The safety of the human AI team, not just the algorithm alone.

5. Deployment

It involves hospitals, cloud systems, or consumer environments.

6. Operations and Monitoring

Continuous monitoring is essential. This includes:

  • Drift detection
  • Logging and audit trails
  • Alerting mechanisms

7. Real World Performance Evaluation

The real world data helps identify:

  • Performance degradation
  • Workflow issues

8. Sunsetting

Sunsetting includes controlled withdrawal, stakeholder communication, and lawful data retention, ensuring patient safety even when systems are retired.

Final Thoughts

The IMDRF Technical Framework provides a global blueprint for managing AI enabled medical devices. By integrating quality systems, human oversight, transparency, and continuous evaluation.

For guidance visit : https://lnkd.in/ghhvbEec

Team NB Updates

Team NB’s Proposals for MDR/IVDR Revision

Team NB’s Proposals for MDR/IVDR Revision

Team NB has published its consolidated input on the European Commission’s targeted revision of the EU MDR and IVDR, drawing on the practical experience of nearly 50 notified body experts across governance, safety, clinical evaluation, and notified body sustainability.

Key takeaways from the review:

Stronger Governance

Team NB proposes a Medical Devices Coordination Office (MDCO) as the operational backbone of the EU system streamlining workflows and coordination while preserving regulatory, scientific, and policy independence.

Clearer, More Robust Expert Panel Governance

The paper calls for transparent governance of expert panels, including:

  • Standing panels for borderline/classification, breakthrough (BtX), and orphan devices
  • Strict independence rules while allowing NB experts to contribute their expertise
  • Structured interaction between notified bodies and expert panels

Clinical Evaluation

Team NB strongly questions proposals that dilute requirements on:

  • Clinical equivalence (similar is not the same as same)
  • Article 61(10) (recommended for removal due to ongoing ambiguity)
  • Well Established Technologies (WET)—urging a restrictive definition or binding device lists to avoid regulatory loopholes and patient risk

Safety Oversight Must Remain Preventive

The document warns that reducing audits, technical documentation sampling, and PSUR reviews risks shifting the EU system from preventive to reactive oversight.

Team NB recommends a performance based model, rewarding strong compliance .

Focus on early lifecycle risks while maintaining late stage vigilance

Notified Body Sustainability

Rising costs, increased administrative burden, and tighter financial constraints threaten NB capacity, competency, and independence which will have consequences for manufacturers, SMEs, and patient access.

Bottom line:

Team NB’s proposals offer a pragmatic roadmap: smarter coordination, clearer clinical rules, and risk based oversight without dismantling the preventive foundations of MDR/IVDR. For manufacturers, this signals the potential for a more predictable, transparent, and innovation supportive EU regulatory environment.

Team NB’s Best Practice Guidance for MDR Technical Documentation

Team NB’s latest position paper (Version 4, April 2026) offers manufacturers a unified roadmap for preparing and submitting technical documentation under Annex II and III of the EU Medical Device Regulation (MDR 2017/745).

Importance

Technical documentation is the backbone of MDR compliance. Yet, many submissions face delays due to incomplete information, inconsistent language, poor translations, or disorganized file structures. Team NB’s collaborative approach provides clarity on expectations, helping manufacturers avoid common pitfalls and accelerate certification timelines.

Key Highlights from the Guidance

1. General Considerations

  • Incomplete or inconsistent submissions remain the biggest cause of delays.
  • Documentation must be clear, searchable, and cohesive, with consistent device descriptions across all sections.
  • File formats should be practical (preferably PDF), with size limits and bookmarking for ease of review.

2. Communication with Notified Bodies

  • Manufacturers are encouraged to engage in structured dialogue before submission to clarify language, labelling, and format requirements.
  • Early alignment reduces rework and ensures smoother assessments.

3. Technical Documentation Submission

  • Submissions must follow Annex II structure with logical folder organization.
  • Verification and validation reports must be complete and linked to risk management IDs.
  • Consistency across duplicated information (e.g., UDI, intended use, contraindications) is critical.

4. Previous Assessments

  • Evidence from prior conformity assessments may be reused if requirements and data remain unchanged.
  • Manufacturers should reference previous NB reports to avoid duplication and shorten review timelines.

5. Device Description & Classification

  • Intended purpose, patient population, user profile, and use environment must be clearly defined.
  • Classification rationale under Annex VIII must be documented, with strictest rules applied when multiple apply.
  • For software (SaMD/SiMD), versioning policies and module specific compliance must be detailed.

Conclusion

Team NB’s position paper is not just a checklist it’s a strategic blueprint for MDR compliance. By aligning submissions with these best practices, manufacturers can build trust with notified bodies, and hence can accelerate certification, bring safe, effective medical technologies to market faster.

USA Updates

eMDR Update: FDA’s Electronic Medical Device Reporting

eMDR Update: FDA’s Electronic Medical Device Reporting

From April 14, 2025, the FDA’s ESG NextGen Unified Submission Portal (USP) replaced the previous WebTrader interface. This new platform provides a user friendly, web based environment for submitting regulatory information and tracking submissions through Center receipt.

Who Must Report?

Under 21 CFR Part 803:

  • Manufacturers and importers must submit adverse event reports electronically in accordance with CFR 803.12(a) and 803.20.
  • Distributors are required to maintain incident records but not required to submit reports.
  • User facilities: May continue submitting written reports, though electronic reporting is available.

System Enhancements

The FDA has introduced several improvements to the eMDR system:

  • Integration with Health Level Seven (HL7) Individual Case Safety Report (ICSR) standards for consistency in safety data exchange.
  • Enhanced troubleshooting support and contact resources for stakeholders.
  • Real time system status updates to improve transparency and reliability.

Importance

For medical device manufacturers and importers, compliance with eMDR is not optional it is a regulatory requirement. The move to ESG NextGen reflects FDA’s commitment to:

  • Streamlined submissions
  • Improved data quality
  • Greater accountability in adverse event reporting

Conclusion

The FDA’s transition to the ESG NextGen Unified Submission Portal marks a major step in modernizing medical device reporting. For manufacturers and importers, adapting to this system is essential to remain compliant, maintain transparency, and for patient safety.

To read more visit : https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/emdr-electronic-medical-device-reporting

Switzerland Updates

Swissmedic’s Updated Guidance on Medical Device Software

Swissmedic’s Updated Guidance on Medical Device Software

Published April 2026

Swissmedic’s latest information sheet (BW630_30_007, Version 3.0) provides a comprehensive outline for manufacturers, developers, and economic operators working with medical device software (MDSW).

Key Highlights

1. Legal & Regulatory Framework

Medical device software falls under MedDO and IvDO and aligns with EU MDR (2017/745) and IVDR (2017/746). Swissmedic also references the FADP (Data Protection Act) and the HRA (Human Research Act), highlighting the overlap between medical regulation, data privacy, and clinical research.

2. MDCG Guidelines & Standards

The sheet consolidates critical MDCG guidance, including:

  • MDCG 2019 11: Qualification & classification of software
  • MDCG 2019 16: Cybersecurity for medical devices
  • MDCG 2020 1: Clinical evaluation of MDSW
  • MDCG 2023 4: Hardware/software combinations

Technical standards such as EN 62304 (software lifecycle), ISO 14971 (risk management), and ISO 13485 (quality management systems) remain foundational.

3. Qualification Criteria

Software qualifies as a medical device if it serves a medical purpose for individuals, beyond simple data storage or communication.

4. Classification Rules

Rule 11 of EU MDR sets strict boundaries for Class I software, permitting functionalities like disease monitoring or injury compensation. Importantly, software that influences diagnostic or therapeutic decisions may be classified higher than the hardware it supports (e.g., cancer image analysis tools).

5. Regulatory Requirements

Manufacturers must demonstrate compliance with:

  • General safety & performance requirements (Annex I MDR/IVDR)
  • Technical documentation (Annexes II & III MDR/IVDR)
  • Clinical evidence & performance evaluation (MDCG 2020 1)
  • Product identification & UDI assignment (MDCG 2018 5)
  • Distance sales provisions for online medical services

6. Obligations & Surveillance

Economic operators including importers, distributors, and authorised representatives must follow obligations under MedDO and IvDO. Post market surveillance, vigilance, and traceability requirements, ensuring patient safety.

Importance

Swissmedic’s updated guidance reflects the growing complexity of digital health. For developers and manufacturers compliance is not optional from cybersecurity to usability engineering, every aspect of medical device software must be designed with patient safety and regulatory readiness in mind.

Conclusion

Medical device software is no longer just accessories it is at the core of modern healthcare innovation. Swissmedic’s framework provides clarity for stakeholders navigating regulatory pathways, ensuring that innovation aligns with patient safety and compliance.

To read more visit https://www.swissmedic.ch/swissmedic/en/home.html

Canada Updates

Health Canada’s April 2026 Guidance: New Terms & Conditions for Medical Devices

Health Canada’s April 2026 Guidance: New Terms & Conditions for Medical Devices

Health Canada has published new guidance on the use of terms and conditions (T&Cs) for Class II to IV medical devices. This update, effective January 1, 2026, expands the Minister’s authority to impose or amend T&Cs at any point during a device’s lifecycle, ensuring safety and effectiveness remain central to market access.

Importance

T&Cs are regulatory tools designed to manage uncertainties and risks connected with medical devices. They allow Health Canada to:

Maintain device safety and effectiveness throughout its lifecycle.
Optimize benefits while managing risks.
Collect additional evidence when uncertainties arise, especially in real world use.

T&Cs are used as regulatory tools to help ensure that medical devices in Canada continue to meet the safety and effectiveness requirements outlined in sections 10 - 20 of the Medical Devices Regulations (MDR).

Key Features of the Guidance

  • Applies to Class II–IV medical device licences under subsection 36(2) of the MDR.
  • Excludes T&Cs for lots of IVDs (section 37) and urgent public health need authorizations.
  • T&Cs may be imposed immediately after licensing or later, based on new evidence.
  • Licence holders are notified in writing and given an opportunity to be heard (typically 10 days).
  • Amendments can be initiated by Health Canada or requested by licence holders with strong justification.
  • T&Cs imposed or amended after January 1, 2026 will be published in both official languages on the Regulatory Decision Summary (RDS) page.
  • Confidential business information and personal data will remain protected.
  • Non compliance with T&Cs is an offence under section 31.2 of the FDA.
  • Consequences include licence suspension, prosecution, fines, or imprisonment.
  • Health Canada may order recalls if evidence shows a device poses risks.

Implications for Industry

  • Maintaining robust post market surveillance systems.
  • Preparing to submit additional evidence when uncertainties arise.
  • Engaging proactively with Health Canada.
  • Ensuring timely communication and compliance to avoid enforcement actions.

Final Thought

Health Canada’s expanded use of T&Cs reflects a modern, lifecycle based regulatory approach. It is moving toward a model where it can actively manage devices as they perform in the real world.

Manufacturers should review the full guidance document or consult Sushvin Consultancy Services for specific cases.

For guidance visit : https://lnkd.in/ghhvbEec

South Africa Updates

SAHPRA Clarifies Licensing Rules for Outsourced Medical Device Activities

SAHPRA Clarifies Licensing Rules for Outsourced Medical Device Activities

On 8 April 2026, the South African Health Products Regulatory Authority (SAHPRA) issued guidance (MD02 2026/27) to stakeholders on licensing requirements for outsourced or contracted activities for medical device establishments.

Key Highlights

1. Licensing requirement for all

  • Manufacturers, distributors, and wholesalers must obtain licences under Section 22C of the Medicines and Related Substances Act (Act 101 of 1965).
  • Outsourcing does not exempt regulatory obligations.

2. Manufacturer Scenarios

  • Sterilisation, packaging, labelling, maintenance, modification, reprocessing, and refurbishing are all considered manufacturing activities.
  • A third party performing these activities must hold a manufacturer licence and must comply with quality management standards (ISO 13485).
  • Outsourced entities are recognized as critical suppliers in the manufacturer’s QMS.

3. Distributor Scenarios

  • Importers and distributors must have a distributor licence for handling medical devices in their final stage, wrapping and packaging.
  • Labelling must clearly identify the licensed South African importer/distributor.

4. Quality & Safety Obligations

  • Outsourced service providers is also responsible for device safety, performance, and compliance.
  • Activities such as secondary labelling or repackaging are explicitly defined as manufacturing, requiring licensing.

Conclusion

SAHPRA’s April 2026 guidance states that licensing requirements cannot be waived or transferred through contracts. All parties involved in manufacturing, distribution, or modification of medical devices whether directly or via outsourcing must hold the appropriate licence and operate under ISO 13485.

This strengthens South Africa’s regulatory framework, aligning it with global framework ,safeguarding patients, healthcare professionals, and the health system.

For guidance visit: https://lnkd.in/ghhvbEec

India Updates

CDSCO’s Guidance on Medical Device Software in India

CDSCO’s Guidance on Medical Device Software in India

The Central Drugs Standard Control Organization (CDSCO) has published a draft guidance document to clarify how Medical Device Software (MDS) is regulated under India’s Medical Devices Rules (MDR), 2017. This guidance is important for manufacturers and importers of software-based medical technologies, including Software in a Medical Device (SiMD) and Software as a Medical Device (SaMD).

Purpose of the Guidance

The document aims to help stakeholders understand the submission process for licenses and permissions related to medical device software. It emphasizes compliance with MDR 2017 and provides clarity on definitions, classifications, and regulatory pathways.

Types of Medical Device Software

  • SiMD: Embedded software which is driving or influencing a medical device (e.g., pacemaker firmware, insulin pump controllers).
  • SaMD: Software performing medical purposes independently (e.g., AI based diagnostic tools, mobile health apps).

Risk-Based Classification

Medical device software is classified into Class A (low risk) to Class D (high risk) under MDR 2017.

For SaMD, classification depends on:

  • Healthcare condition (critical, serious, non serious).
  • Significance of information ( for treatment,diagnosis, driving clinical management, or informing clinical management).
  • SaMD used for critical conditions and providing diagnostic or treatment information - Class D (high risk).
  • SaMD used for non serious conditions and only for information- Class A (low risk).

Regulatory Pathways

Applications must be submitted via:

  • NSWS Portal for test licenses.
  • CDSCO MD Online Portal for manufacturing/import licenses.
  • Manufacturers must also comply with Quality Management System (QMS) requirements, aligned with ISO 13485.

Post-Market Requirements

The guidance highlights obligations such as:

  • Post Marketing Surveillance (PMS)
  • Periodic Safety Update Reports (PSURs)
  • Field Safety Corrective Actions (FSCA)

These provides ongoing safety and performance monitoring after commercialization.

Final Thought

India’s medtech ecosystem is changing fast, and software is at the center of innovation ,from AI driven diagnostics to digital health platforms. By clarifying definitions, risk classifications, and regulatory pathways, CDSCO is helping manufacturers and importers align with global best practices.

For guidance visit https://lnkd.in/ghhvbEec

ISO Updates

ISO 14155:2026 – Clinical Investigations of Medical Devices for human subjects

ISO 14155:2026 – Clinical Investigations of Medical Devices for human subjects

The International Organization for Standardization (ISO) has published the fourth edition of ISO 14155:2026, replacing ISO 14155:2020. This update is a critical step forward in defining Good Clinical Practice (GCP) for medical device investigations, ensuring patient safety, scientific integrity, and regulatory alignment.

Key Changes in ISO 14155:2026

The revision introduces several important changes and new requirements:

  • Clinical performance definition updated for greater precision.
  • Eligibility criteria deviations now require formal Clinical Investigation Plan (CIP) amendments.
  • Informed consent strengthened, including provisions for legally designated representatives and opportunities for subjects to consult family.
  • Risk management clarified, distinguishing risks from device use vs. clinical procedures outside routine practice.
  • Residual risk assessment now mandatory.
  • Data Monitoring Committee (DMC) requirements expanded, including justification if no DMC is involved.
  • Clinical Events Committee (CEC) introduced to oversee event adjudication.
  • Adverse event reporting streamlined with clearer categorization and reduced reporting in defined situations.
  • Implant card requirement added for better patient information.
  • Study design updates including estimands, non inferiority margins, handling missing data, and calibration of equipment.
  • Training and precautions expanded to include in silico testing and device specific training.

Scope

ISO 14155:2026 specifies the good clinical practice (GCP) requirements for designing, conducting, recording, and reporting clinical investigations with human participants to evaluate medical devices' performance, effectiveness, and safety.

For Software as a Medical Device (SaMD), the standard applies to analytical validity, scientific validity, and clinical performance as far as relevant. It is not applicable for in vitro diagnostic devices.

Action required

Organisations should conduct a gap analysis against ISO 14155:2026 and proactively update their processes. Those already aligned with ISO 14155:2020 will find the transition slightly easier, but important updates are still required across study design, conduct, and reporting.

Conclusion

The publication of ISO 14155:2026 sets a new global standard for medical device clinical investigations. For MedTech innovators, early adoption is key to ensuring compliance, building trust with regulators, and advancing innovation responsibly.

To read more visit : https://lnkd.in/d4xYvq2z

ISO 10993 6:2026 – Biological Evaluation of Medical Devices

The International Organization for Standardization (ISO) has published the fourth edition of ISO 10993 6:2026, Biological evaluation of medical devices — Part 6: Tests for local effects after implantation.

What the Standard Covers

It covers implantation test methods used for the characterization of the local tissue respond following implantation of medical devices. These tests assess local tissue responses to medical devices intended for use where the skin or mucosal tissue is breached.

The main changes are as follows:

  • new definitions for comparative control, coupon, euthanasia, local effect, location marker, steady-state and reference control have been added to Clause 3;
  • a new paragraph on the use of smaller compositionally representative samples or coupons has been added to 4.2.2;
  • a new subclause 4.3 Selection of control materials has been added;
  • the discussion of assessment of lymph nodes for certain materials has been expanded;
  • a new Annex E Test methods for devices contacting peripheral nerve tissue and Annex G Microscopic evaluation of tissue responses to implanted materials have been added;
  • tissue and pathological terminology have been updated throughout this document;
  • bibliographical entries have been updated.

What It Does Not Cover

ISO 10993 6:2026 does not cover systemic toxicity, carcinogenicity, teratogenicity, or mutagenicity.

Conclusion

ISO 10993-6:2026 improves the safety of implanted medical devices by addressing local biological effects after implantation. For manufacturers this standard is not just a compliance requirement, it’s essential for earning trust from regulators, clinicians, and patients.

https://www.iso.org/obp/ui/en/ - iso:std:iso:10993:-6:ed-4:v1:en

ISO Medical Devices Update (1March–1April 2026)

The International Organization for Standardization (ISO) continues to advance global harmonization in medical device standards. Between 1 March and 1 April 2026, several new committee drafts (CDs) and draft international standards (DIS) were registered and circulated.

Key Committee Drafts (CD) in Medical Devices

  • ISO/CD 20896-1 (Dentistry) Digital impression devices – Part 1: Methods for assessing accuracy. This draft sets out standardized methods to evaluate the precision of digital dental impression systems, critical for ensuring reliable prosthetics and orthodontic outcomes.
  • ISO/CD 25695 (Biological and clinical evaluation of medical devices) Medical devices utilizing bioengineered biological substances – Application of risk management.

Draft International Standards (DIS) in Medical Devices

  • ISO/DIS 11737-1 Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products 2026-05-29 (Revision of ISO 11737-1:2018, ISO 11737-1:2018/Amd 1:2021
  • ISO/DIS 24051-1 Medical laboratories — Part 1: General principles for the application of artificial intelligence in medical laboratories 2026-06-12
  • ISO/DIS 11615.2 - Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information 2026-05-25 (Revision of ISO 11615:2017, ISO 11615:2017/Amd 1:2022)

Important /Standards published

  • ISO/TR 4234:2026 (Implants for surgery) Non-active surgical implants — Implant coating — Best practices for coating system assessmen
  • ISO 4074:2026 (Non-systemic contraceptives and STI barrier prophylactics) Natural rubber latex male condoms — Requirements and test methods
  • ISO 20417:2026 - Medical devices - Information to be supplied by the manufacturer
  • ISO 16791:2026 - Health informatics — Requirements for international machine-readable coding of medicinal product package identifiers
  • ISO 14155:2026 : Clinical investigation of medical devices for human subjects — Good clinical practice
  • ISO 10451:2026 Dentistry — Contents of a technical file for dental implant systems

In summary:

The March–April 2026 ISO update highlights the organization’s commitment to advancing medical device safety and innovation. Stakeholders in dentistry, surgical implants, and bioengineered devices should closely monitor these developments.

For guidance visit https://lnkd.in/ghhvbEec

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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