COMBINE Programme: Streamlining EU Combined Studies for Medicines, Devices, and Diagnostics

December 17, 2024

Introduction to the COMBINE Programme

The European Union has taken a significant step towards streamlining combined studies involving medicinal products, medical devices, and in vitro diagnostics (IVDs) through the COMBINE Programme. Endorsed by national authorities across Member States, the programme aims to address long-standing challenges that hinder the efficiency of clinical trials and regulatory approvals under the Clinical Trials Regulation (CTR), Medical Device Regulation (MDR), and In Vitro Diagnostic Regulation (IVDR).

The Need for Streamlined Combined Studies

Combined studies, which investigate the use of multiple healthcare products—such as a medicinal product with a medical device or companion diagnostic—are essential for advancing patient care and supporting innovative treatments. However, the fragmented regulatory processes across the CTR, MDR, and IVDR create significant hurdles:

Administrative Complexity: Sponsors face parallel and often redundant assessment processes across Member States, leading to delays.
Ambiguities in Regulation: Overlapping requirements on reporting and classification of studies often result in confusion.
Harmonisation Gaps: Diverging approaches among national competent authorities slow down multi-country studies.

These challenges risk delaying the development and availability of critical healthcare solutions, impacting patients and stifling innovation.

The COMBINE Programme: A Collaborative EU Initiative

To overcome these challenges, the European Commission launched the COMBINE Programme, a cross-sector initiative designed to foster collaboration between regulatory authorities, ethics committees, and stakeholders. By unifying processes and addressing gaps at the interface of CTR, MDR, and IVDR, the COMBINE Programme sets out to:

Simplify and harmonise the approval of combined studies across the EU.
Improve collaboration between national competent authorities, the European Medicines Agency (EMA), ethics committees, and sponsors.
Enhance Europe’s competitiveness in clinical research, aligning with the recommendations of the Draghi Report.

A Phased Approach to Change

The COMBINE Programme will be implemented over the coming years through seven cross-sector projects that focus on key areas such as piloting single assessment processes, harmonising serious adverse event (SAE) reporting, and enhancing advisory services for sponsors. The programme reflects a shared commitment to supporting innovation while ensuring patient safety and regulatory efficiency across the EU.

The Seven Cross-Sector Projects of the COMBINE Programme

The COMBINE Programme will be implemented through seven cross-sector projects, each addressing specific challenges in the regulatory landscape of combined studies. These projects represent a collaborative effort between national competent authorities, ethics committees, the European Medicines Agency (EMA), and other stakeholders to streamline processes, harmonise reporting, and improve advisory services for sponsors.

1. Piloting a Single Assessment Process for Multi-Country Combined Studies

Objective: Introduce a coordinated, unified assessment process for combined studies involving medicinal products, medical devices, and in vitro diagnostics across multiple EU Member States.
Why It Matters: Current processes require separate national submissions under different frameworks (CTR, MDR, and IVDR). This pilot project aims to reduce duplication, align timelines, and ensure a single, streamlined review process.
Outcome: A harmonised approach that accelerates study approvals, reduces administrative burden, and improves efficiency for sponsors conducting multinational combined studies.

2. Harmonisation of Serious Adverse Event (SAE) Reporting Processes

Objective: Align the reporting requirements for Serious Adverse Events (SAEs) across the CTR, MDR, and IVDR frameworks.
Challenges Addressed: SAEs are reported differently under each regulation, creating confusion and inefficiencies for sponsors and regulators. Lack of harmonised processes delays decision-making and impacts patient safety monitoring.
Outcome: A unified, consistent SAE reporting process that improves clarity, facilitates timely reporting, and ensures compliance across sectors.

3. Clarifying the Interface Between Clinical Trials and Medical Device Regulations

Objective: Resolve regulatory ambiguities where the Clinical Trials Regulation (CTR) intersects with the Medical Device Regulation (MDR) and IVD Regulation (IVDR).
Key Questions Addressed: When does a study require a Clinical Trial (CT), a Clinical Investigation (CI), or a Performance Study (PS)? How should combined studies be classified and approved under multiple regulatory frameworks?
Outcome: Clear, harmonised guidelines for sponsors and regulators to navigate the interface between these regulations, ensuring smoother approvals and regulatory compliance.

4. Enhancing Advisory Services for Sponsors

Objective: Explore new opportunities for providing coordinated, cross-sector advice to sponsors conducting combined studies.
Why It Matters: Sponsors often face uncertainty when designing combined studies due to fragmented regulatory advice. A lack of centralized guidance increases the risk of regulatory non-compliance and delays.
Outcome: Improved advisory mechanisms, such as coordinated pre-submission meetings, that help sponsors navigate regulatory complexities, streamline submissions, and accelerate study timelines.

5. Facilitating Knowledge Exchange Between National Authorities

Objective: Promote collaboration and knowledge sharing among national competent authorities, ethics committees, and regulatory bodies.
Key Actions: Establish platforms for cross-sector dialogue and exchange of best practices. Encourage joint discussions on shared challenges, such as study assessments, adverse event reporting, and ethical considerations.
Outcome: A stronger, more unified regulatory network capable of addressing challenges efficiently and supporting the successful implementation of combined studies across the EU.

6. Aligning Regulatory Timelines and Approval Processes

Objective: Harmonise the timelines and approval procedures for combined studies under the CTR, MDR, and IVDR frameworks.
Challenges Addressed: Variations in national processes and timelines result in delays, particularly for multi-country studies. Sponsors face inconsistent requirements, creating additional administrative burden.
Outcome: A coordinated approach that aligns national approval processes, ensures predictable timelines, and fosters greater consistency across Member States.

7. Strengthening Stakeholder Engagement for the COMBINE Programme

Objective: Foster open dialogue and collaboration with key stakeholders, including sponsors, clinicians, patient representatives, and ethics committees.
Why It’s Important: Involving stakeholders ensures that the solutions developed under the COMBINE Programme are practical, efficient, and patient-centric. Enhanced engagement helps address real-world challenges faced by industry and clinicians in conducting combined studies.
Outcome: Improved stakeholder collaboration that ensures the programme’s goals align with industry needs, supports innovation, and prioritises patient outcomes.

Driving Regulatory Innovation Through the COMBINE Programme

The seven cross-sector projects under the COMBINE Programme address the core challenges of combined studies by streamlining processes, clarifying regulatory requirements, and fostering collaboration across the EU. These efforts are essential for improving efficiency, reducing delays, and enabling the development of innovative treatments that combine medicines, medical devices, and diagnostics.

Why the COMBINE Programme Matters

The COMBINE Programme represents a pivotal step toward addressing the regulatory inefficiencies that have long challenged combined studies involving medicinal products, medical devices, and diagnostics. By introducing streamlined processes, harmonising reporting requirements, and fostering collaboration, the programme delivers tangible benefits for all stakeholders.

For Sponsors and Manufacturers: Streamlined Approval Processes

Simplified Submissions: The COMBINE Programme eliminates duplication by piloting a single assessment process for multi-country combined studies.
Reduced Administrative Burden: Sponsors will no longer have to navigate fragmented processes under the CTR, MDR, and IVDR, reducing time spent on regulatory paperwork.
Faster Approvals: Harmonised timelines and improved coordination across Member States will accelerate approvals for combined studies, enabling quicker market entry for innovative products.

For a sponsor conducting a clinical trial of a medicinal product alongside a performance study of an IVD, the single assessment process reduces redundant national submissions, ensuring a smoother and faster pathway to approval.

For National Competent Authorities and Ethics Committees: Improved Collaboration and Efficiency

Unified Approach: The programme fosters collaboration between national authorities, ethics committees, and the EMA, ensuring consistency in study evaluations.
Knowledge Sharing: By facilitating the exchange of best practices, authorities can address common challenges, such as adverse event reporting and interface ambiguities, more effectively.
Efficient Use of Resources: Coordinated assessment processes streamline workflows, reducing the strain on regulatory bodies and ensuring a more efficient allocation of resources.

For Patients: Faster Access to Innovative Treatments

Accelerated Innovation: By simplifying regulatory pathways, the COMBINE Programme ensures that groundbreaking treatments—such as combined therapies and diagnostics—reach patients more quickly.
Improved Safety: Harmonised serious adverse event (SAE) reporting enhances patient safety by ensuring timely and consistent monitoring across all regulatory sectors.
Personalised Medicine: Combined studies enable the development of advanced solutions, such as companion diagnostics paired with targeted therapies, leading to more tailored and effective treatment options.

In diseases like cancer, where combined studies often involve companion diagnostics and therapies, delays in approval can mean a delay in access to life-saving treatments. The COMBINE Programme aims to eliminate these delays, prioritising patient needs.

For the EU: Enhancing Global Competitiveness

Addressing Recommendations from the Draghi Report: The Draghi Report underscored the importance of regulatory efficiency in maintaining the EU’s leadership in clinical research and innovation. The COMBINE Programme aligns directly with these goals, strengthening Europe’s position as a global hub for clinical trials.
Attracting Global Studies: A streamlined, harmonised approach makes the EU more attractive for multinational combined studies, encouraging sponsors to invest in research within Europe.
Supporting Innovation Ecosystems: By addressing regulatory hurdles, the programme fosters an environment conducive to innovation, benefiting SMEs, manufacturers, and healthcare systems.

The COMBINE Programme positions Europe as a leader in integrated clinical research, ensuring the EU remains competitive in the rapidly evolving MedTech and pharmaceutical industries.

Driving Real-World Impact Across Sectors

By addressing the challenges of combined studies, the COMBINE Programme delivers a balanced solution that benefits all stakeholders. For sponsors, it reduces complexity and accelerates approvals. For regulators, it ensures efficiency and collaboration. Most importantly, for patients, it enables faster access to innovative treatments that improve healthcare outcomes.

The COMBINE Programme and EU Competitiveness

The COMBINE Programme is not only a solution to regulatory complexity but also a cornerstone of the EU’s broader strategy to maintain global competitiveness in clinical research and medical innovation. By streamlining processes and fostering collaboration, the programme positions Europe as a leading region for conducting combined studies that integrate medicinal products, medical devices, and diagnostics.

Addressing the Recommendations of the Draghi Report

The Draghi Report, which outlines key priorities for strengthening Europe’s economic and technological competitiveness, highlights the importance of a streamlined regulatory environment for innovation in clinical research. The COMBINE Programme directly supports these recommendations by:

Reducing Regulatory Complexity: Simplifying combined studies ensures a faster path from research to patient access, allowing Europe to stay ahead of global competition.
Promoting Innovation: A harmonised and efficient system encourages sponsors and manufacturers to invest in research and development within the EU.
Improving Market Access: By removing administrative barriers, new treatments can reach the market sooner, boosting Europe’s role as a leader in health innovation.

Strengthening the EU as a Global Hub for Clinical Research

1. Attracting Multinational Studies

Global sponsors often face challenges when navigating fragmented regulatory systems in the EU. The COMBINE Programme resolves these issues by:

Offering single, coordinated assessments for multi-country studies.
Harmonising timelines and reporting requirements under the CTR, MDR, and IVDR frameworks.

This streamlined approach makes the EU a more attractive destination for conducting global clinical studies, ensuring sponsors can leverage Europe’s vast expertise, resources, and patient access.

2. Fostering Cross-Sector Innovation

The growing trend of personalised medicine relies on combining medicinal products with diagnostic devices. The COMBINE Programme removes regulatory hurdles that delay the integration of:

Companion diagnostics: Ensuring that innovative treatments are paired with advanced diagnostics for targeted patient care.
Advanced therapies: Supporting innovative combined treatments for diseases such as cancer, cardiovascular conditions, and rare diseases.

By addressing these challenges, the EU fosters a dynamic environment where innovation can thrive across sectors, benefiting both industry and patients.

3. Supporting Small and Medium Enterprises (SMEs)

The COMBINE Programme simplifies regulatory pathways, which is particularly critical for SMEs in the MedTech and pharmaceutical sectors. These companies often face resource constraints when navigating complex regulations. By providing:

Clear guidance on the interface between CTR, MDR, and IVDR.
Access to advisory services for combined studies.
Predictable timelines through harmonised processes.

The programme ensures SMEs can bring innovative products to market faster, strengthening Europe’s innovation ecosystem.

Delivering Economic and Healthcare Benefits

The successful implementation of the COMBINE Programme will not only drive regulatory efficiency but also deliver far-reaching benefits across Europe:

Economic Growth:

Attracting more clinical trials and combined studies generates investments in research and development, boosting the EU economy.
Improved innovation pathways strengthen the global competitiveness of EU-based manufacturers and sponsors

Healthcare Advancements:

Patients benefit from accelerated access to cutting-edge treatments that combine medicinal products, medical devices, and diagnostics.
A harmonised system ensures safer, more effective healthcare solutions reach the market efficiently.

For a European SME developing an innovative therapy paired with a diagnostic IVD, the streamlined approval process reduces delays, allowing faster market entry and broader patient access.

The EU’s Vision for Clinical Research Leadership

Through the COMBINE Programme, the European Union reaffirms its commitment to fostering innovation, supporting collaboration, and maintaining its position as a global leader in clinical research. By addressing regulatory inefficiencies and harmonising processes, the programme ensures that Europe remains an attractive hub for sponsors, manufacturers, and researchers driving the next generation of medical advancements.

Key Takeaway

The COMBINE Programme is a critical initiative that strengthens Europe’s competitive edge in clinical research. By simplifying pathways for combined studies, fostering innovation, and aligning with strategic goals outlined in the Draghi Report, the programme sets the stage for economic growth, global leadership, and improved patient outcomes across the EU.

Implementation and Next Steps for the COMBINE Programme

The successful roll-out of the COMBINE Programme requires a structured, phased approach to ensure that its ambitious goals are achieved efficiently and effectively. By leveraging cross-sector collaboration, pilot projects, and continuous evaluation, the programme sets the stage for lasting regulatory improvements across the EU.

COMBINE Programme Phased Rollout

The COMBINE Programme will be implemented in three key stages over the coming years:

1. Stage 1: Pilot and Early Initiatives (2024–2025)

Key Focus:

Launch the pilot for a single assessment process for combined studies involving medicinal products and medical devices across multiple Member States.
Initiate harmonisation efforts for Serious Adverse Event (SAE) reporting, streamlining processes under the CTR, MDR, and IVDR

Actions:

Identify candidate combined studies for the single assessment pilot.
Establish cross-functional task forces to develop and test harmonised SAE reporting frameworks.

Outcome: Early learnings from pilot initiatives will inform best practices and provide actionable insights for scaling solutions across the EU.

2. Stage 2: Scaling and Integration (2025–2026)

Key Focus:

Expand successful pilot initiatives, integrating the single assessment process into broader multi-country studies.
Strengthen cross-sector collaboration by enhancing knowledge exchange between national authorities and ethics committees.

Actions:

Roll out the harmonised assessment framework to additional Member States.
Launch training programmes to support national authorities, ethics committees, and sponsors in implementing new processes.
Develop and publish clear interface guidance to resolve ambiguities between CTR, MDR, and IVDR.

Outcome: A more unified and harmonised approach to combined studies across Member States, improving regulatory efficiency and reducing delays.

3. Stage 3: Full Implementation and Evaluation (2026–2027)

Key Focus:

Achieve full implementation of the programme’s objectives, ensuring long-term sustainability and continuous improvement.
Monitor progress and evaluate the impact of the COMBINE Programme on EU clinical research and innovation.

Actions:

Conduct comprehensive evaluations of the programme’s milestones, assessing its success in streamlining combined studies and supporting stakeholders.
Strengthen engagement with sponsors, clinicians, and patient representatives to identify opportunities for further refinement.
Publish progress reports to share achievements, challenges, and next steps.

Outcome: A fully harmonised regulatory framework that makes the EU a global leader in supporting combined studies of medicinal products, medical devices, and diagnostics.

Key Stakeholders Driving Implementation

The successful implementation of the COMBINE Programme depends on collaboration among a wide range of stakeholders, including:

National Competent Authorities (NCAs): Leading the development and execution of pilot initiatives and harmonised frameworks at the Member State level.
European Medicines Agency (EMA): Providing regulatory expertise, scientific consultation, and coordination for multi-country studies.
Ethics Committees: Aligning ethical review processes with the programme’s streamlined assessment objectives.
Sponsors and Manufacturers: Engaging in pilot studies, providing feedback, and adopting new processes to improve study timelines and regulatory compliance.
Clinicians and Patient Representatives: Contributing real-world perspectives to ensure that the programme prioritises patient safety and healthcare innovation.

Monitoring Progress and Ensuring Accountability

To ensure the COMBINE Programme delivers its objectives, robust monitoring and evaluation mechanisms will be implemented:

Regular Progress Reports: Published at key milestones to assess the programme’s impact, identify challenges, and showcase achievements.
Feedback Loops: Stakeholder input, including sponsors, NCAs, and ethics committees, will be collected to refine processes and address emerging issues.
Performance Metrics: Defined to measure success, including:
- Reduction in approval timelines for multi-country combined studies.
- Increased consistency in serious adverse event reporting.
- Improved clarity on the interface between clinical trials and medical device regulations.

Building a Sustainable Future for Combined Studies

The COMBINE Programme is not just a short-term solution but a long-term framework for driving innovation and efficiency in EU clinical research. By fostering collaboration, aligning processes, and prioritising continuous improvement, the programme ensures that Europe remains at the forefront of healthcare innovation.

What’s Next for Stakeholders?

As the COMBINE Programme progresses, stakeholders can expect:

Opportunities to Participate in Pilots: Sponsors and manufacturers are encouraged to engage with pilot projects for the single assessment process.
Clearer Guidance: Publication of harmonised frameworks and interface clarifications to reduce regulatory ambiguity.
Improved Communication: Enhanced dialogue between regulators, sponsors, ethics committees, and patient representatives.

By working together, all stakeholders can contribute to the success of the COMBINE Programme, ensuring it delivers its vision of a harmonised, streamlined regulatory environment for combined studies.

Key Takeaway: The phased implementation of the COMBINE Programme marks a transformative shift in the EU’s approach to combined studies. Through pilots, collaboration, and continuous evaluation, the programme sets the foundation for faster, more efficient approvals that benefit sponsors, regulators, and—most importantly—patients.

Conclusion: A Unified Vision for Combined Studies

The COMBINE Programme marks a pivotal step in the European Union’s commitment to creating a harmonised, efficient, and collaborative regulatory framework for combined studies. By addressing long-standing challenges at the intersection of the Clinical Trials Regulation (CTR), Medical Device Regulation (MDR), and In Vitro Diagnostic Regulation (IVDR), the programme sets a clear path toward innovation, competitiveness, and improved patient care.

Transforming Regulatory Efficiency

Through its seven cross-sector projects, the COMBINE Programme delivers concrete solutions to streamline combined studies:

Simplifying approvals with a single assessment process for multi-country studies.
Aligning serious adverse event (SAE) reporting across sectors to ensure safety and consistency.
Clarifying regulatory interfaces to resolve ambiguities between clinical trials and device regulations.
Fostering collaboration among national competent authorities, ethics committees, and stakeholders to promote knowledge exchange and efficiency.

These efforts reduce administrative burdens, harmonise timelines, and improve access to clear, actionable regulatory guidance.

COMBINE Programme Supporting Innovation and Competitiveness

By eliminating regulatory fragmentation and ensuring consistent, coordinated processes, the COMBINE Programme positions the EU as a global leader in clinical research and medical innovation.

Sponsors and manufacturers benefit from faster approvals and streamlined pathways, enabling them to bring innovative treatments to market more efficiently.
Patients gain quicker access to integrated healthcare solutions, including advanced therapies, medical devices, and companion diagnostics.
National authorities and ethics committees operate within a more efficient, harmonised framework, reducing duplication and ensuring safety.

In alignment with the Draghi Report recommendations, the COMBINE Programme strengthens Europe’s competitive edge, attracting global investment and driving economic growth in the MedTech and pharmaceutical sectors.

Looking Ahead: A Future of Innovation and Collaboration

The COMBINE Programme is more than a regulatory initiative; it is a transformative vision for the future of clinical research in the EU. By fostering collaboration, harmonising processes, and streamlining combined studies, the programme paves the way for a new era of healthcare innovation.

As Europe continues to lead the charge in medical and clinical advancements, the COMBINE Programme will play a critical role in ensuring that innovative treatments reach patients faster, safer, and more effectively.

Key Takeaway: The COMBINE Programme unifies the efforts of regulators, stakeholders, and innovators to streamline combined studies, strengthen Europe’s leadership in clinical research, and deliver groundbreaking healthcare solutions to patients across the EU.

Call to Action for the COMBINE Programme

Are you planning or conducting a combined study involving medicines, medical devices, or diagnostics? The MDx team is here to help you navigate the complexities of the COMBINE framework. Contact us today to streamline your regulatory strategy and ensure the success of your combined study.

Get in touch with the MDx team now to accelerate innovation and bring your study to life!

Industry Insights & Regulatory Updates 2

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EU Reference Laboratories under IVDR: What Class D Manufacturers Must Know

September 6, 2024

The In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 created European Union Reference Laboratories (EURLs) to strengthen oversight of high-risk (Class D) IVDs. Article 100 sets their role, while the Commission has adopted implementing rules that spell out how EURLs must be organised, resourced and monitored. For manufacturers, especially those developing Class D assays, understanding what EURLs do—and when their involvement is triggered—is essential for planning performance verification, batch testing and timelines.

The legal backbone

Article 100 IVDR establishes EURLs, their tasks and the criteria they must meet.
Commission Implementing Regulation (EU) 2022/944 lays down the detailed requirements EURLs must fulfil (people, equipment/reference materials, QMS/standards, organisation and administration, confidentiality/privacy, impartiality, outsourcing controls, accreditation, and verification of ongoing compliance).
Commission Implementing Regulation (EU) 2023/2713 designates the first EURLs and sets the application date for their activities (from 1 October 2024).

What EURLs will check for Class D devices

For specific Class D devices, EURLs perform independent performance verification and batch testing as part of conformity assessment, per Article 100(2)(a)–(b). Practically, this means an extra scientific check on claimed performance characteristics and lot release testing where required—on top of your notified body assessment. Manufacturers should plan analytical panels, availability of reference materials, and timelines with EURL capacity in mind.

Key requirements defined for EURLs (what the rules actually say)

The 2022/944 implementing act translates Article 100(4) into concrete obligations. In short, EURLs must demonstrate:
Personnel competence and independence; fit-for-purpose equipment, specimens, control and reference materials; adherence to international standards and best practices; robust organisation and administration; confidentiality and data protection; independence and conflict-of-interest controls; controlled outsourcing; appropriate accreditation; and continuous verification of compliance (including Commission audits and potential suspension/withdrawal if criteria are not met).

Timeline and transition

The designating act (2023/2713) confirms that designated EURLs apply from 1 October 2024. From that date, new applications that fall into an EURL scope are expected to route performance verification/batch testing to the relevant EURL as part of the NB procedure. Stakeholder guidance from authorities and NBs has reiterated that devices already under assessment or certified prior to that date may be handled under specific transition arrangements—check with your NB for case-by-case impacts.

Practical steps for manufacturers

Align your performance evaluation and verification plans with potential EURL panel requirements early (sample sizes, reference materials, panels for pathogen/biomarker variability). Confirm whether your device category falls within an EURL designation scope and build the extra review time into your project and submission plans. Engage your NB to understand dossier routing, language requirements for materials, and any specific expectations tied to EURL interactions. Public notices from NBs and authorities provide useful summaries as the system scales.

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IVDR Performance Studies and the ISO 20916:2024 Revision

April 2, 2024

ISO 20916: Introduction

ISO 20916, “Clinical performance studies using specimens from human subjects – Good study practice” was first published in 2019 and recently released as EN ISO 20916:2024 (European Standard) at the end of March 2024, harmonizing IVDR Performance Studies with this latest revision.

In the rapidly evolving landscape of in vitro diagnostic (IVD) medical devices, maintaining the highest standards of safety and performance is paramount. ISO 20916 stands as a cornerstone in this endeavor, providing a framework for the quality and reliability of IVDs used in clinical performance studies employing human subject specimens.

This standard encapsulates comprehensive practices for planning, designing, conducting, recording, and reporting clinical performance studies for IVD devices. It lays down the foundational principles and specifies general requirements aimed at assessing clinical performance and safety for regulatory purposes. It has been meticulously designed to ensure that IVDs meet stringent criteria, thereby safeguarding public health and enhancing patient outcomes. It is intended to aid regulatory compliance, ensuring studies yield robust, ethical, and reliable results.

MDx will host a live free webinar on “Preparing for IVDR Clinical Performance Studies under ISO20916 and the new annex ZA” on the 30th April 2024 at 5pm CET. Register here.

The importance of Annex ZA of ISO 20916:2024 in IVDR performance studies

At the end of March 2024, the IVD community witnessed a significant milestone with the publication of a new revision of ISO 20916 which harmonizes IVDR performance studies. While the standard was already referenced in the text of the IVDR, this revision is particularly notable for the inclusion of Annex ZA, which finally harmonizes the standard with the In Vitro Diagnostic Regulation (IVDR) (Regulation (EU) 2017/746).

This harmonization of performance studies marks a critical step in aligning the standard with the comprehensive requirements set forth by the IVDR, thus facilitating a more streamlined regulatory pathway for IVD manufacturers. The significance of Annex ZA cannot be overstated. It bridges the gap between ISO 20916 and the IVDR, providing a clear and actionable framework for manufacturers to achieve compliance.

The text of ISO 20916:2019 has been approved by CEN (the European Committee for Standardization) as EN ISO 20916:2024 without any modification. This inclusion is a strategic enhancement, reinforcing the standard’s relevance and applicability in the regulatory landscape.

Note: As of the date this article was written, the official recognition of ISO 20916:2024 as an IVDR harmonized standard for clinical performance studies in the European Union’s Official Journal was awaiting confirmation.

Success in IVD Clinical Performance Studies with MDx CRO

At MDx CRO, we navigate the complexities of IVDR and the latest ISO 20916 revision for in vitro diagnostic (IVD) studies with unmatched expertise. Our commitment to rigorous clinical operations ensures that every clinical performance study meets all regulatory standards, incorporating strategic risk management and adaptability for maximum compliance and integrity.

Partnering with us offers manufacturers a significant advantage, rigorously evaluating IVDs to ensure adequate performance and safety, a critical component of regulatory approvals.

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Highlights from Annex ZA include:

Presumption of Conformity: Compliance with the normative clauses of ISO 20916, as specified in Table ZA.1, confers a presumption of conformity with the corresponding GSPRs of the IVDR. This presumption is a testament to the robustness of the standard in meeting regulatory expectations.
Definition Clarification: Where differences arise between definitions in ISO 20916 and those in the IVDR, Annex ZA ensures clarity by highlighting these differences. The annex prioritizes the definitions set out in the IVDR, underscoring the regulation’s primacy.
Risk Management Alignment: The annex emphasizes the necessity of aligning the risk management process in EN ISO 20916:2024 with the IVDR. This alignment ensures that risks associated with IVDs are “reduced as far as possible”, in accordance with the regulation’s stringent requirements. In addition, ISO 20916 does not include foreseeable misuse in the risk management process, as required by IVDR.
Manufacturer’s Policy on Acceptable Risk: Annex ZA clarifies that the manufacturer’s approach to determining acceptable risk must adhere to specific GSPRs (i.e. 1, 2, 3, 4, 5, 8, 10, 11, 13, 15, 16, 17, 18 and 19) outlined in the IVDR. Furthermore, when reducing risks, sponsors, CROs, manufacturers and other stakeholders should note that while ISO 20916 does not include user training as a risk reduction measure, this is indeed allowed under IVDR.

Synergies between ISO 20916 and IVDR:

IVDR clinical performance parameters: Generally aligned between ISO 20916 and IVDR, however note that ISO 20916 does not mention “expected values in normal and affected populations” as a clinical performance parameter.
Ethical considerations: Generally aligned but ISO 20916 is a lot more prescriptive when compared to IVDR, defining ethical considerations and responsibilities for all parties involved, including principal investigators and sponsors.
Measures to minimise bias in study design: ISO 20916 further defines specific areas that should be considered when avoiding bias, including population bias, bias in the test protocol, bias in the reference measurement procedure, etc.
Site qualification: ISO 20916 provides a more detailed framework for site qualification, covering several criteria, including investigator qualifications, adequate resources and facilities, validated equipment , lab’s quality management system etc.
Clinical performance study report (CPSR): ISO 20916 is in general a lot more prescriptive on the contents of the clinical performance study report. Additional requirements are provided for interventional and other performance studies involving risks to the subjects.
Comparator devices used in an IVD performance study: Generally aligned, but ISO 20916 defines further how comparator IVDs should be listed, including their commercial name, manufacturer and catalogue number for example.
Investigators Brochure (IB) for Annex XIV studies: both IVDR and ISO 20916 are aligned. Annex C in ISO 20916 is dedicated to the contents of the IB. In addition ISO 20916 is a lot more prescriptive than IVDR on requirements related to risk management and risk-benefit analysis that need to be described in the CPSP and IB.

Differences to be aware of:

Differences in Annex XIV studies (and IVDR article 58): The definitions of an Annex XIV study in IVDR (i.e. interventional and other performance studies involving risks to the subjects) are different from ISO 20916. Although Annex ZA considers both the standard and regulation to cover the same elements and therefore being aligned, the description of what is in essence an Annex XIV study is different when we look at the detail. For example, the IVDR recognizes surgically invasive sample taking as being an Annex XIV study, while ISO 20916 does not use this terminology.
Adverse events: Although both IVDR and ISO 20916 are considered aligned, there are differences in the categorization of adverse events occurring in clinical performance studies. ISO 20916 provides two main types of events: non-device-related and device-related, and further categorizes this into non-serious and serious, anticipated, and non-anticipated. The IVDR is not as prescriptive in this area.
Clinical performance study plan (CPSP): ISO 20916 is more prescriptive on the specimen details to be listed in the CPSP, including their storage. In addition, ISO 20916 does not require reference to the current state of the art in diagnosis and/or medicine, whereas this is a requirement from IVDR. Last but not least, ISO 20916 has specific requirements for the CPSP synopsis.
Monitoring plan: ISO 20916 is a lot more prescriptive on the requirements for the monitoring plan, including qualification and training of monitors. According to ISO 20916 sponsors can also develop a rationale for remote monitoring. In addition, whereas IVDR requires that sponsors appoint a monitor independent of the investigation site, this point is not mandated by ISO 20916.
Informed Consent: A lot more detail is provided in ISO 20916 when compared to IVDR. The standard offers a detailed framework for obtaining informed consent.

Who Benefits from EN ISO 20916:2024?

Manufacturers of in vitro diagnostic medical devices
In vitro diagnostic clinics and laboratories
Test centres for in vitro diagnostic medical devices
Regulatory authorities
IVDR Notified Bodies
IVD Clinical research organizations (CROs)
Investigators and sponsors

Advantages of Adopting EN ISO 20916 for IVD Performance studies

Robust Results: It ensures high-quality, accurate, and reliable data generation, pivotal for safe healthcare decisions.
Ethical Standards: It upholds the rights, safety, dignity, and well-being of study subjects.
Study Planning and Conduct: It facilitates the meticulous planning and execution of IVD performance studies, ensuring regulatory and ethical compliance alongside scientific validity.
Compliance and Clarity: It provides a framework for compliance with IVDR, clarifying roles and responsibilities of all parties involved.
Risk Management: It emphasizes subject safety, especially regarding specimen collection risks, and ensures data integrity.

Implications for IVD Performance Studies and CRO Services

The integration of ISO 20916 with the IVDR, highlighted by the inclusion of Annex ZA, significantly transforms IVD clinical performance studies and CRO operations. This crucial alignment demands a comprehensive revision in study design, execution, and reporting methodologies, highlighting the importance of compliance with the unified ISO 20916 and IVDR standards. It emphasizes the need for robust quality and risk management systems and ethically responsible study development.

This evolution signifies more than standard adherence; it represents a commitment to elevating IVD performance and efficacy in line with the highest EU regulatory standards. It requires IVD stakeholders, including CROs, sponsors and manufacturers, to deeply understand and agilely apply these standards, not only for compliance but to set new quality and safety benchmarks in diagnostics.

This commitment is fundamental to advancing patient care and public health, marking a significant step forward in regulatory compliance and industry excellence.

Since its foundation, MDx CRO has consistently used ISO 20916 as the benchmark for all our IVD clinical performance studies. The release of Annex ZA and its harmonization with IVDR reinforces our status as the leading CRO for IVD clinical performance studies.

Written by:

Carlos Galamba

CEO

Senior regulatory leader and former BSI IVDR reviewer with deep experience in CE marking high-risk IVDs, companion diagnostics, and IVDR implementation.

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FDA Laboratory Developed Tests (LDTs) Regulation

October 4, 2023

FDA’s new LDT regulation underscores the vital role of IVD CROs in compliance and safety. Phased over four years without grandfathering, it highlights the necessity for IVD CROs’ regulatory expertise and their key role in aligning LDTs with stringent standards, marking a significant shift in the IVD landscape.

Introduction

The Food and Drug Administration (FDA) recently released a groundbreaking proposed rule on September 29, 2023, aiming to transform its existing approach toward Laboratory-Developed Tests (LDTs). This paradigm shift directly impacts In Vitro Diagnostic products (IVDs) and their regulation. The proposed rule presents a layered plan for LDTs, phasing out FDA’s longstanding policy of enforcement discretion. For stakeholders in the IVD sector, including clinical laboratories and LDT manufacturers, the implications of this proposed rule are monumental.

Key Points to Consider as the FDA regulates LDTs

Modification to IVD Definition: The FDA aims to explicitly categorize LDTs as IVDs within the scope of 21 CFR Part 809.3, thus making them subject to FDA’s medical device regulations, including premarket review.
Phased Implementation: The FDA proposes to gradually roll back its enforcement discretion policy for LDTs, segmenting the regulatory shifts over five distinct stages across a four-year period.
No Grandfather Clause: Unlike previous considerations, the new proposal doesn’t plan to “grandfather” existing LDTs. Public commentary on this subject is invited.
Test Exemptions: Specific test types, such as forensic and human leukocyte antigen tests, are marked for exemption from enhanced regulatory oversight.
Comment Period: Stakeholders have until December 4, 2023, to submit their feedback on the proposed rule.

Background on FDA Regulation for LDTs and IVDs

IVDs have traditionally been subject to rigorous regulatory scrutiny under various heads:

510(k) premarket notification or premarket approval (PMA)
Quality system regulation
Medical device reporting
Registration and listing
Labeling

These IVDs also fall under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). LDTs, a specialized category within IVDs, have long operated under enforcement discretion, essentially receiving less stringent oversight. This approach historically aligned with the perception of LDTs as low-risk products, but the proposed rule acknowledges the evolved complexity and widespread use of LDTs in modern healthcare.

The Evolving Landscape of LDTs

Over the past 50 years, the role of LDTs has changed dramatically, making the FDA regulation of Laboratory Developed Tests increasingly crucial. Their growing prevalence and the technical sophistication involved have prompted calls for stronger regulatory oversight. These significant developments have culminated in the FDA’s renewed perspective on LDTs. Shedding its previous stance of general enforcement discretion, the FDA Laboratory Developed Tests Regulation now aims to redefine LDTs broadly, addressing potential regulatory gaps and emphasizing the need for robust public health protection.

The Road Ahead: Implications and Recommendations

The phased implementation approach impacts various aspects of medical device regulation:

Medical Device Reporting: Will be the first area where enforcement discretion will cease.
Quality Systems: Expected to come under scrutiny three years after the final policy is published.
Premarket Review: To be phased in 3.5 to four years after the final policy, impacting high-risk IVDs first and then trickling down to moderate-risk and low-risk IVDs.

Given these imminent changes, clinical labs offering LDTs must prepare for enhanced regulatory compliance and for increased FDA regulation of Laboratory developed tests. These labs should develop protocols for both analytical and clinical validity, ensuring alignment with new regulatory expectations.

Synergies with the EU’s IVDR roll-out

In Europe, a similar regulation, the In Vitro Diagnostic Regulation (IVDR), is being phased in, emphasizing the importance of compliance for in house developed tests. Under IVDR, laboratories must ensure that their Technical Documentation and Quality Management System are up-to-date and comply with the regulation and the national law. Failure to comply with the IVDR can result in serious consequences, including fines, loss of accreditation, and even closure of the laboratory.

Furthermore, laboratories that develop in-house IVDs will be required to comply with similar requirements for manufacturing as commercial IVD manufacturers. This means that laboratories must ensure that their IVDs meet high standards for safety and performance, which can only be achieved through rigorous testing and validation.

It is important to note that the IVDR specifically includes in-house developed tests, including LDTs and CE marked IVDs modified by laboratories. If an equivalent CE marked device is available on the market or IVD product is manufactured at an industrial scale, the laboratory cannot use exemption for LDT´s provided in the IVDR (Article 5.5) and must CE mark the IVD. MDx CRO has recently published an article assessing the impact of the IVDR on LDTs.

Conclusion: An Industry in Transition

As specialists in quality, regulatory, and clinical consultancy focused on IVDs, MDx CRO advises stakeholders to take proactive measures in anticipation of these sweeping regulatory changes. Judicial challenges and public feedback could alter the timeline for the FDA to start regulating LDTs, but there’s no doubt that enhanced regulation of LDTs is on the horizon, already in full force in Europe.

Comments on the Proposed FDA Rule should be submitted by December 4, 2023, to help shape this crucial regulatory development. It is an opportune time for the industry to engage in open dialogue and to prepare for the inevitable changes that lie ahead.

Written by:

Carlos Galamba

CEO

Senior regulatory leader and former BSI IVDR reviewer with deep experience in CE marking high-risk IVDs, companion diagnostics, and IVDR implementation.

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Monkeypox Diagnostic Test Specifications: Navigating WHO’s TPPs

August 24, 2023

WHO publishes specifications for monkeypox tests

The World Health Organization (WHO) has recently unveiled two pivotal Target Product Profiles (TPPs) for monkeypox diagnostic test specifications. As the diagnostic landscape evolves, it becomes imperative for diagnostic manufacturers to align with these international benchmarks. MDx CRO stands at the forefront as a strategic CRO and regulatory consulting partner to navigate these benchmarks with precision and compliance.

Deciphering WHO’s TPPs

The intended patient population in both TPPs are individuals suspected of monkeypox infection, including children and adults, TPP1 is tailored for NAAT (nucleic acid amplification tests) qualitative diagnostic test applications within healthcare settings and laboratories. TPP1 is directed towards laboratories or point of care facilities, such as a outpatient or STI clinics, emergency units or other settings near patient care. It mandates a test that boasts high diagnostic sensitivity (≥95%), specificity (≥97%) when compared to a reference molecular method.

Sample type: lesion material or mucosal swabs (excluding saliva).
The test’s intended user is typically laboratory personnel or a trained healthcare professional (when used near-patient).
Closed molecular systems and tests that do not require extraction prior to amplification/detection are preferred.
Test design: 2 independent target regions with at least one target that is monkeypox specific. The IFU should specify the assay’s target region.
Results should be obtained in under 4 hours and preferable under 1 hour.

In contrast, TPP2 should be used for tests that aid the diagnosis of orthopoxvirus antigens, such as qualitative lateral flow immunoassays tailored for decentralized used, including in the community, rural environments and low-resource settings. Results should be interpreted visually and/or through digital readout via smartphone. Tests should demonstrate adequate diagnostic sensitivity (≥80%), specificity (≥97%) for community based settings when compared to a reference molecular method.

Sample type: lesion material, mucosal swabs or saliva. When present, lesions are the preferred sample type.
The test should be designed for use by non-lab trained intended users.
The target analyte is the monkeypox virus antigen/protein. Tests targeting antibody detection are not acceptable.
Results should be obtained quickly in under 40 minutes and preferable under 20 minutes, a crucial feature for time-sensitive environments such as outbreak regions or remote settings

The creation of WHO monkeypox diagnostic test specifications was underpinned by a comprehensive process, involving myriad experts from fields such as science, public health, and regulation. A crucial step involved a public consultation phase, ensuring the TPPs were refined with broad feedback before finalization. This initiative by WHO is a hallmark in the trajectory of creating robust diagnostic tools for monkeypox and related orthopoxviruses.

Partnering with MDx CRO for your monkeypox test development

MDx CRO is unwavering in its commitment to support the development and clinical trials that meet monkeypox diagnostic test specifications. Our services, fortified by vast expertise, encompass areas such as meticulous IVD clinical performance study design, efficient sample collection and analysis, and stringent regulatory compliance across multiple jurisdictions, with an emphasis on CE marking under the IVDR.

While the TPPs provide an essential blueprint, the diagnostic journey also demands attention to several critical facets:

Study Populations: Defining the optimal study population is paramount. Such a population should encompass individuals potentially benefiting from the test, including those suspected of monkeypox or those at elevated risk of exposure.
Reference Standards: Leveraging appropriate reference standards ensures validation of the test’s accuracy and reliability, forming the backbone of its developmental and evaluative processes. Samples should cover a range of clinically relevant viral loads as per the reference method used.
IVD Clinical Study Design of monkeypox tests should include prospective or leftover specimens, covering a clinically relevant viral load. MDx CRO can help design and execute clinical performance studies in alignment with the WHO TPP and IVDR CE mark expectations.

With the scientific acumen and regulatory insights of MDx CRO, diagnostic manufacturers can confidently navigate the intricacies of the WHO’s TPPs and other global benchmarks.

Planning to develop an IVD monkeypox test or to conduct an EU based clinical trial? Contact us today to find out how MDx CRO can accelerate your development journey.

Written by:

Carlos Galamba

CEO

Senior regulatory leader and former BSI IVDR reviewer with deep experience in CE marking high-risk IVDs, companion diagnostics, and IVDR implementation.

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IVDR Transition: Insights from the Dutch Authority

August 11, 2023

State of play of IVDR Transition:

In the realm of in vitro diagnostics (IVD), a seismic shift is underway as manufacturers grapple with the complexities of transitioning to the new European In Vitro Diagnostic Regulation (IVDR). This transition, necessitated by advancements in technology and evolving patient safety concerns, brings both challenges and opportunities for IVD manufacturers. A recent report by the Dutch Competent Authority (IGJ) delves into the progress, setbacks, and strategies of IVD manufacturers in their journey toward IVDR compliance. Over 40% of respondents raised doubts about whether they will be able to obtain the CE marking for their IVDs before the transition periods expire.

The IGJ Report Findings:

The IGJ report sheds light on the multifaceted landscape of the IVDR transition. Manufacturers are confronted with stringent requirements that demand a paradigm shift in their approach to product development, documentation, quality assurance, and post-market surveillance. The report identifies several key challenges:

Technical Documentation Overhaul: The IVDR mandates comprehensive and meticulously documented technical files and dossiers. This demand presents a considerable challenge as manufacturers strive to align existing documentation with the new regulations. Additionally, the dynamic nature of diagnostic technologies requires continuous updates, further complicating the documentation process. Gathering of IVDR Clinical Evidence is particularly challenging for manufacturers due to lack of guidelines and international coordination. For example, application for clinical performance studies across Member States is not fully harmonised.
Certification Complexities: Acquiring the necessary certification from Notified Bodies is a crucial step in the IVDR transition. However, the IGJ report underscores the intricate nature of the certification process, involving rigorous assessments and evaluations. This complexity can lead to delays in bringing products to market. Notified Bodies have reported delays in the certification process due to lack of information in the IVDR technical documentation and also lack of structure and clarity in the file.
Post-Market Surveillance Emphasis: The IVDR places increased importance on post-market surveillance (PMS) and vigilance. Manufacturers are expected to establish robust systems for monitoring the performance and safety of their products throughout their lifecycle. This shift necessitates a proactive approach to identifying and addressing potential issues. 80% of respondents have adapted their vigilance procedures to IVDR requirements, however compliance to PMS System, PMS plan and PMPF requirements is lower, at 70% of respondents. The IGJ has declared they will promote or enforce compliance through random inspection visits.
Educational Imperative: The IGJ report emphasizes the significance of educating all stakeholders, from manufacturers to regulatory bodies, about the intricacies of IVDR compliance. Adequate training is crucial to ensure that everyone understands their roles, responsibilities, and the broader implications of the new regulation.

The Role of MDx CRO in your IVDR Transition:

Amid these challenges, MDx CRO emerges as a guiding light for IVD manufacturers. As the industry grapples with the transformative implications of the IVDR, MDx CRO stands as a stalwart partner, offering expert guidance and tailored solutions to navigate the evolving regulatory landscape.

Strategic Guidance: MDx CRO’s team of seasoned experts provides strategic advice that empowers manufacturers to make informed decisions. Transitioning to the IVDR isn’t just about compliance; it requires a forward-looking approach that considers the long-term impact on products and business strategies.

Technical Documentation Excellence: The IGJ report highlights the criticality of accurate and comprehensive technical documentation. MDx CRO’s expertise shines in this arena, aiding manufacturers in compiling technical files and dossiers that meet IVDR standards while showcasing the safety and innovation of their products.

Certification Support: With the certification process’s complexities highlighted in the report, MDx CRO’s collaborative approach becomes invaluable. By assisting manufacturers in preparing for interactions with Notified Bodies, MDx CRO streamlines the certification journey, ensuring quicker time-to-market for products. Read about our pre-submission service.

Continuous Partnership: The IGJ report’s emphasis on post-market surveillance aligns with MDx CRO’s commitment to the entire product lifecycle. Beyond the transition, MDx CRO supports manufacturers in establishing robust PMS systems, enabling them to meet ongoing compliance and safety monitoring requirements.

Knowledge Dissemination: As underscored by the report, education is pivotal in a successful IVDR transition. MDx CRO’s training and workshops empower manufacturers with the insights and understanding needed to navigate the new landscape with confidence.

Conclusions:

The IGJ report provides a comprehensive view of the challenges and advancements in the IVD sector’s transition to IVDR compliance. One message is clear, the IGJ unequivocally mandates manufacturers to expedite IVDR certification without delay. This is key to prevent peak in applications when the transition period come to an end. Within this landscape, MDx CRO emerges as a crucial enabler, equipping manufacturers with the tools, expertise, and support needed to thrive in the new regulatory era. By offering strategic guidance, technical excellence, certification support, ongoing collaboration, and knowledge dissemination, MDx CRO paves the way for compliant, innovative, and patient-centered IVD products. As the industry continues to navigate the evolving regulatory seas, MDx CRO stands as a steadfast partner in this transformative journey.

Contact our team today to discuss your IVDR transition needs!

Written by:

Carlos Galamba

CEO

Senior regulatory leader and former BSI IVDR reviewer with deep experience in CE marking high-risk IVDs, companion diagnostics, and IVDR implementation.

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