Tag: post market surveillance

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Building IVD Compliance Pathways Through Effective Regulatory Strategies

Introduction

In vitro diagnostic (IVD) medical devices play a critical role in healthcare decision-making, influencing approximately 70% of all clinical decisions. As these technologies advance and global markets expand, navigating the complex regulatory landscape has become increasingly challenging for manufacturers. The path to compliance requires strategic planning, thorough understanding of regulatory frameworks, and implementation of robust quality management systems.

Effective regulatory strategies for IVD manufacturers seek to navigate compliance pathways efficiently and successfully bring their products to market across global jurisdictions, including UK, EU and USA.

The Evolving IVD Regulatory Landscape

IVDR in Europe: A Paradigm Shift

The European Union’s In Vitro Diagnostic Regulation (IVDR 2017/746) marked a significant evolution from the previous In Vitro Diagnostic Directive (IVDD 98/79/EC). This transition brought more stringent requirements, including:

  • Risk-based classification system (Classes A, B, C, and D)
  • Enhanced clinical evidence requirements
  • Increased post-market surveillance
  • Greater involvement of Notified Bodies
  • Unique Device Identification (UDI) implementation

The IVDR’s phased implementation continues to present challenges for manufacturers, particularly those with legacy products requiring recertification or first-time market entrants.

FDA Approach to IVDs

In the United States, the Food and Drug Administration (FDA) regulates IVDs as medical devices, categorizing them primarily through:

  • Class I: General controls (lowest risk)
  • Class II: Special controls and often 510(k) premarket notification
  • Class III: Premarket Approval (PMA) for highest risk devices

Global Harmonization Efforts

The International Medical Device Regulators Forum (IMDRF) continues to work toward harmonizing regulatory approaches worldwide. However, significant differences remain among jurisdictions, creating challenges for manufacturers pursuing global market access. The utilisation of IMDRF can be a valuable tool to develop a ‘one size fits all’ technical file – although this doesn’t quite work in practise. The Uks indication of using IMDRF principles is a welcome signal which may support future international recognition.

Building Strategic Compliance Pathways

1. Early Regulatory Strategy Development

Successful IVD manufacturers integrate regulatory planning into their product development lifecycle from inception. Key elements include:

  • Regulatory roadmapping: Documenting intended markets, timelines, and certification requirements
  • Classification determination: Early assessment of product risk classification across target jurisdictions
  • Regulatory intelligence gathering: Monitoring evolving requirements and guidance documents
  • Stakeholder alignment: Ensuring business, R&D, quality, and regulatory teams share understanding and objectives

Early strategic planning significantly reduces time-to-market and development costs by avoiding regulatory surprises and rework. It is important to consider the end goal – market access, and work backwards, when developing your design and development strategies.

2. Risk-Based Approach to Compliance

Implementing a risk-based approach aligns with modern regulatory frameworks and optimizes resource allocation:

  • Product risk classification: Understanding how regulatory bodies will classify your device
  • Risk management process: Implementing ISO 14971 principles throughout the product lifecycle
  • Benefit-risk analysis: Documenting how benefits outweigh residual risks
  • Risk-based quality management: Focusing QMS efforts proportionally to risk areas

This approach ensures compliance while maintaining operational efficiency. While this is a requirement to meet regulatory requirements, done right, this can add real value to the development and operational efficiency of IVD manufacturing in conjunction with ISO 13485

3. Building Robust Clinical Evidence

Enhanced clinical evidence requirements represent one of the most significant challenges in modern IVD regulation:

  • Scientific validity: Establishing the analyte’s association with clinical condition
  • Analytical performance: Demonstrating technical performance characteristics
  • Clinical performance: Providing evidence of clinical utility and outcomes
  • State-of-the-art analysis: Comparing performance against current alternatives
  • Literature-based strategies: Leveraging existing scientific literature effectively

For novel IVDs, well-designed clinical performance studies with clearly defined endpoints are increasingly essential.

4. Comprehensive Quality Management Systems

A robust QMS serves as the foundation for sustainable compliance:

  • ISO 13485:2016 implementation: Adopting the international standard for medical device QMS
  • Process approach: Defining interconnected processes with clear ownership
  • Design controls: Implementing systematic design and development procedures
  • Supplier management: Controlling purchased components and services
  • Post-market surveillance: Establishing vigilance and feedback systems

Integrated QMS software solutions can streamline documentation and enhance traceability across regulatory jurisdictions.

For the European Union (IVDR), Manufacturers are expected to have a compliant QMS to IVDR from June 2025.

5. Documentation and Technical File Preparation

Strategic documentation management is critical for efficient submissions:

  • Common Technical Documentation (CTD): Organizing technical files in internationally recognized formats
  • Modular approach: Designing core documentation adaptable to different jurisdictions
  • Traceability matrices: Ensuring regulatory requirements are comprehensively addressed
  • Gap analysis tools: Identifying and addressing documentation deficiencies

Electronic document management systems with regulatory intelligence capabilities can significantly enhance efficiency.

For the EU, many Notified Bodies provide guidance and template structures for how they expect to see Technical Documentation to be constructed. For classes B to D, it is recommended to engage with your NB early and understand their expectations of the conformity assessment process.

Advanced Regulatory Strategies for Complex Challenges

Companion Diagnostics

As precision medicine advances, companion diagnostics face unique challenges requiring coordinated regulatory strategies:

  • Drug-diagnostic co-development: Aligning timelines with pharmaceutical partners
  • Combined submissions: Navigating coordinated reviews between device and drug divisions
  • Harmonized clinical studies: Designing trials that satisfy both diagnostic and therapeutic endpoints

Early engagement with regulatory authorities through pre-submission meetings is particularly valuable for companion diagnostics.

Software as a Medical Device (SaMD)

IVDs increasingly incorporate software components or exist entirely as software, requiring specialized regulatory approaches:

  • SaMD framework implementation: Applying IMDRF risk categorization principles
  • Cybersecurity considerations: Addressing security by design principles
  • Artificial intelligence/machine learning: Navigating evolving regulatory expectations for adaptive algorithms
  • Agile development: Reconciling iterative development with regulatory requirements

The FDA’s Digital Health Software Precertification Program signals evolving approaches to software regulation that may influence other jurisdictions.

Point-of-Care and Self-Testing IVDs

Decentralized testing presents unique regulatory considerations:

  • Usability engineering: Demonstrating safe use by intended users
  • Human factors studies: Collecting evidence in simulated use environments
  • Simplified instructions: Developing clear usage guidance for lay users
  • Risk mitigation: Implementing safeguards against user error

Regulatory expectations for usability have increased significantly, particularly for tests intended for self-administration.

Creating Sustainable Compliance

Regulatory Intelligence Systems

Maintaining current regulatory intelligence is essential for sustainable compliance:

  • Monitoring mechanisms: Establishing systems to track regulatory changes
  • Gap assessment processes: Evaluating impact on existing products and pipelines
  • Strategic response planning: Developing action plans for significant regulatory shifts
  • Knowledge management: Maintaining institutional regulatory expertise

Subscription services and industry associations can provide valuable regulatory intelligence resources. Examples include our partners Medboard.

Post-Market Compliance Strategies

Regulatory responsibility extends well beyond initial approval:

  • Post-market surveillance planning: Designing proportionate monitoring systems
  • Real-world evidence collection: Gathering data on performance in clinical settings
  • Periodic safety update reports: Preparing comprehensive safety summaries
  • Change management: Navigating modifications to approved devices

Proactive post-market strategies can identify issues early and support expanded indications.

Building Regulatory Partnerships

Successful manufacturers view regulatory bodies as partners rather than obstacles:

  • Pre-submission consultations: Engaging early with authorities on novel technologies
  • Scientific advice meetings: Seeking input on clinical evidence plans
  • Regulatory inspections: Approaching audits as improvement opportunities
  • Transparent communication: Maintaining open dialogue about challenges

Building positive regulatory relationships creates pathways for more efficient future submissions.

Conclusion

The evolving IVD regulatory landscape presents significant challenges but also opportunities for manufacturers who implement strategic approaches to compliance. By integrating regulatory considerations throughout the product lifecycle, adopting risk-based methodologies, generating robust clinical evidence, and maintaining adaptable quality systems, manufacturers can navigate compliance pathways more efficiently.

Success in today’s regulatory environment requires not just understanding current requirements but anticipating future developments. Organizations that view regulatory strategy as a competitive advantage rather than a necessary burden are better positioned to bring innovative diagnostic solutions to patients while maintaining compliance across global markets.

As the diagnostic landscape continues to evolve with technological advances in digital health, precision medicine, and point-of-care testing, regulatory strategies must likewise adapt. By building sustainable compliance systems and fostering positive relationships with regulatory authorities, IVD manufacturers can create pathways to market that support innovation while ensuring safety and efficacy.

How can we help?

IVDeology has a long history of working with IVD manufacturers to define their regulatory strategy based on their company goals and objectives. We establish long term partnerships with our customers to ensure they meet the regulatory requirements for market access, and through the post market phase. To learn more about how we can help, contact [email protected].

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How to Get Your QMS Ready for IVDR (25 May 2025)

With less than a month to go before the requirement kicks in for a valid Quality Management System (QMS) complaint to the EU IVD Regulation (IVDR), most IVD manufacturers who have placed IVDs on the European market (or any region where you are using the CE mark, including the UK) should be ready for the change.

If you are not one of them, you need to start thinking about the below very quickly!

A Strategic Approach for IVD Companies
The IVDR represents one of the most significant regulatory shifts for IVD manufacturers in recent history. With stricter requirements for quality management systems, technical documentation, and post-market surveillance, achieving IVDR compliance demands a comprehensive transformation of your existing quality processes. Here’s how to prepare your QMS effectively.


Understand the IVDR QMS Requirements
The IVDR significantly enhances the QMS expectations compared to the previous IVD directive (IVDD).


The regulation specifically references ISO 13485:2016 as a presumption of conformity, making this standard the foundation for IVDR-compliant quality systems. The EU harmonised version of this standard, EN ISO 13485:2016A11:2021, includes the handy Annex Z correspondence between the IVDR and ISO 13485


Gap Analysis: Your First Critical Step
Before implementing changes, conduct a thorough gap analysis of your current QMS against IVDR requirements:

  • Review existing procedures against IVDR Article 10 (manufacturer obligations), Annex I (general safety and performance requirements), and Annex IX (QMS and technical documentation assessment)
  • Assess your product classifications under the new risk-based system (Classes A through D)
  • Identify documentation gaps, particularly around clinical evidence and performance evaluation
  • Evaluate your post-market processes for alignment with intensified surveillance requirements

A structured gap analysis provides a clear roadmap of required changes and helps prioritize critical areas.


Key QMS Modifications for IVDR Compliance

1. Risk Management Integration
The IVDR requires risk management to be integrated throughout your QMS, not just during design phases:

  • Update your risk management procedure to align with ISO 14971:2019
  • Establish risk controls that span the entire product lifecycle
  • Implement benefit-risk analysis methodologies
  • Create documentation that demonstrates continuous risk assessment


2. Performance Evaluation System
Develop a robust performance evaluation system that includes:

  • Scientific validity assessment for each analyte
  • Analytical performance verification
  • Clinical performance studies (where applicable)
  • A performance evaluation plan and report (PER)
  • Documented procedures for updating performance evaluation throughout the product lifecycle


3. Post-Market Surveillance System
Strengthen your post-market surveillance (PMS) system to include:

  • A PMS plan specific to each device
  • A PMS report (for Class A and B devices) or periodic safety update report (PSUR) for Class C and D devices
  • Trend reporting for incidents
  • Processes for implementing field safety corrective actions (FSCAs)
  • Integration of PMS data into risk management and performance evaluation.

4. Supply Chain Oversight
The IVDR places greater responsibility on manufacturers for supplier and distributor oversight:

  • Develop procedures for qualifying and monitoring critical suppliers
  • Implement appropriate supplier agreements covering IVDR requirements
  • Establish clear roles and responsibilities for economic operators
  • Create systems for verifying unique device identification (UDI) implementation across the supply chain

5. Person Responsible for Regulatory Compliance (PRRC)
Designate a qualified person responsible for regulatory compliance who will:

  • Ensure product conformity is appropriately verified
  • Maintain technical documentation and EU declarations of conformity
  • Fulfill post-market surveillance obligations
  • Ensure reporting requirements for serious incidents are met

6. Documentation Strategy for IVDR
Documentation requirements under IVDR are extensive. Implement a systematic approach:

  • Update your quality manual to reflect IVDR-specific requirements
  • Revise existing internal procedues to incorporate new requirements and references
  • Develop new procedures for gaps identified in your analysis
  • Create templates for technical documentation aligned with Annexes II and III
  •  Implement document management systems capable of maintaining the necessary documentation throughout the product lifecycle


Conclusion: A Transformed Approach to Quality
IVDR compliance isn’t simply about updating documents, it represents a fundamental shift in how IVD manufacturers approach quality management. By systematically addressing each aspect of the regulation, you can transform your QMS from a documentation-focused system to a truly integrated approach that enhances product safety and performance.

It is recommended that you liaise with your certification/notified body, they may have further guidance on what they would like to see, and how to lay out specific documents and QMS infrastructure before any auditing takes place. Remember it is in everyone’s best interest to ensure manufacturers are compliant, including notified bodies and competent authorities. If you don’t have a notified body, this is a great place to start!


The investment in your QMS now will not only ensure regulatory compliance but also strengthen your market position through improved product quality and enhanced patient safety. Begin your IVDR transformation today to ensure continued access to the European market and position your organization for future growth in an increasingly regulated industry.

You can speak to us by booking in our calendar here, or email [email protected] to discuss investing into your QMS, whether that be QMS hosting or uplifting, IVDeology can support.

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What Are EU Reference Labs for IVDs?

EU Reference Labs for IVD’s – explained

In vitro diagnostic medical devices (IVDs) play a vital role in providing essential information for the diagnosis, monitoring, and treatment of diseases.  IVDs must comply with the In Vitro Diagnostic Medical Device Regulation (IVDR – Regulation (EU) 2017/746) to be placed on the European Union (EU) market.

The IVDR introduced the concept of EU Reference Laboratories (EURLs) for IVDs. EURLs are specialised laboratories designated by the European Commission, to provide scientific and technical expertise for specific types of high-risk IVDs. The designation and responsibilities of EURLs are outlined in Article 100 of the IVDR and more details are laid out in Commission Implementing Regulation (EU) 2022/944.

Designation & Responsibilities of EURLs

For a laboratory to be designated as an EURL by the European Commission, it must:

  • Demonstrate appropriate expertise and experience in the relevant field
  • Have adequate staff with appropriate qualifications
  • Possess necessary equipment and reference materials
  • Show impartiality and independence from commercial interests
  • Comply with ISO/IEC 17025 and other relevant standards
  • Have appropriate quality management systems in place

Once designated, EURLs’ tasks include the following:

  • Performance Verification – EURLs verify the performance claims of class D IVDs by conducting laboratory tests on samples provided by manufacturers i.e., EURLs carry out tests on each manufactured batch of devices.
  • Common Specifications Development – EURLs contribute to the development of common specifications and technical guidance for specific types of devices.
  • Technical Assistance – EURLs provide scientific advice and technical assistance to national authorities, notified bodies and manufacturers.
  • Reference Materials Management – EURLs establish, manage, and make available reference materials and methods for high-risk IVDs.
  • Coordination Role – EURLs coordinate a network of national reference laboratories to harmonize testing methodologies and practices across the EU.
  • Research and Innovation – EURLs contribute to research and innovation in their specific areas of expertise.

Types of IVDs Subject to EURL Assessment

The EURLs verify the performance claims and carry out batch testing on high-risk (Class D) IVDs:

  • Devices which detect the presence of / exposure to, a transmissible agent in blood / blood components / cells tissues / organs / any of their derivatives, to assess their suitability for transfusion / transplantation / cell administration.
  • Devices which detect the presence of / exposure to, a transmissible agent that causes a life-threatening disease with high propagation risk.
  • Devices which determine the infectious load of a life-threatening disease, where monitoring is critical in the process of patient management.
  • Devices for blood grouping, which determine any of the following markers:
    • ABO system [A (ABO1), B (ABO2), AB (ABO3)]
    • Rhesus system [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)]
    • Kell system [KEL1 (K)]
    • Kidd system [JK1 (Jka), JK2 (Jkb)]
    • Duffy system [FY1 (Fya), FY2 (Fyb)]

Impact on the Industry

EURLs for IVDs have an impact on both IVD manufacturers and notified bodies.

Manufacturers of class D IVDs must submit samples of their device to an appropriately designated EURL for the EURL to verify performance claims and compliance to any common specifications. Manufacturers must then incorporate any feedback into their technical documentation. Prior to release of a batch of any Class D IVDs, manufacturers must wait for EURLs to confirm they have completed their tests.

Notified bodies will need to consult with EURLs when assessing certain high-risk IVDs and factor in EURL’s opinions into their assessment decisions. Notified bodies will also have to maintain communication with EURLs for post-market surveillance.

Implementation Challenges

Although the IVDR became fully applicable on 26 May 2022, implementation of the regulation has not necessarily been smooth. The timelines to which certain devices must be compliant to the IVDR have been extended more than once and establishing a EURL network has been challenging. Resources have been restrained, as building the necessary infrastructure and hiring the appropriate expertise has required significant investment and coordination.

As a result, the European Commission adopted a phased approach to EURL designation and until EURLs are fully operational for all relevant device categories, interim procedures have been established for the conformity assessment of class D IVDs. MDCG 2021-4 provides guidance on how EURLs should be integrated into the conformity assessment process when designated.

Current State of Play

The European Commission have designated the following 5 EURLs by the implementing act Commission Implementing Regulation (EU) 2023/2713

Designated EU reference laboratoryScope of designation Class D devices intended for detection or quantification of markers of:
Consortium managed by Servicio Madrileño de Salud (SERMAS), Spain and composed of: Hospital General Universitario Gregorio Marañón, Spain Hospital Universitario la Paz, Spain Hospital Universitario Ramón y Cajal, SpainHerpesvirus infection Infection with bacterial agents
Consulting Químico Sanitario SLU (CQS), SpainHerpesvirus infection Infection with bacterial agents
EU Referenzlabor für In-vitro-Diagnostika am Paul-Ehrlich-Institut (PEI-IVD), Germany Hepatitis or retrovirus infection Respiratory virus infection
Instituto de Salud Carlos III (ISCIII), SpainHepatitis or retrovirus infection Herpesvirus infection  Infection with bacterial agents
RISE Research Institutes of Sweden AB (RISE), SwedenRespiratory virus infection

These EURLs took up their tasks in the conformity assessment of devices on 1 October 2024.

In February 2025, the European Commission launched a further call for more applications to be submitted by Member States on behalf of their candidate laboratories for designation of EURLs. This call will be conducted in 2 waves.

The 1st wave is for the following categories of class D devices:

  • detection or quantification of markers of arbovirus infection
  • detection or quantification of markers of parasite infection
  • detection of blood grouping markers

Laboratories must submit applications to their Member State by 15 April 2025 (note: this date is indicative and laboratories should check with their specific Member State).

Member States must forward applications to the Commission by 6 June 2025.

The 2nd wave is for any of the following 8 categories of class D devices:

  • detection or quantification of markers of hepatitis or retrovirus infection 
  • detection or quantification of markers of herpesvirus infection 
  • detection or quantification of markers of infection with bacterial agents
  • detection or quantification of markers of arbovirus infection
  • detection or quantification of markers of respiratory virus infection
  • detection or quantification of markers of infection with haemorrhagic fever viruses or other biosafety level 4 viruses
  • detection or quantification of markers of parasite infection
  • detection of blood grouping markers

Laboratories must submit applications to their Member State by 15 January 2026 (note: this date is indicative and laboratories should check with their specific Member State).

Member States must forward applications to the Commission by 15 April 2026.

Conclusion

EURLs play a critical role in ensuring certain Class D IVDs are safe and effective. Although there are interim procedures in place for the conformity assessment of Class D IVDs, the IVD industry will benefit from the certainty of having enough designated EURLs to cover all categories of Class D devices.

Let’s hope this new call for further applications for designation of EURLs will provide additional resources the EU IVD industry desperately needs.

If you’re looking for a regulatory partner to offer compliance advise and support, get in touch with IVDeology today to begin your new partnership or email us at [email protected]

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US IVD Classification – How different can it be?

IVDeology have decades of IVD (invitro diagnostics) compliance support experience within the Quality and regulatory industry, with backgrounds from microbiology to lab based experience, and recently becoming part of the Abingdon Health PLC to offer a more holistic range of services from cradle to grave of diagnostic products. Co-founder and Director of training Nancy Consterdine talks about the US classifications of devices, having worked recently with US 510K submissions including pre-submissions.

The Global Harmonisation Task Force (GHTF) published their classification guidance in June 2006 proposing a risk based, 4 tier classification system for In Vitro Diagnostic Devices. This guidance has been widely used since 2006 for new regulatory systems being set up around the world e.g. the IVD Regulation in Europe 2017/746.

However, the United States of America (US) had already introduced a 3-tier risk-based classification system back in 1976 with the amendments to the Food, Drug and Cosmetics act (FD&C) to include medical devices. This system has now been in place for 48 years, despite amendments having been made around the regulatory pathways e.g. introduction of the 510K De Novo program, enacting of the Small Business Determination program and electronic submission processes. So, how does the classification system work currently and what are the future changes that the FDA are proposing?

Figure above shows class |, || and ||| and risk (explained below)

Class 1

  • Low to Moderate Risk devices e.g. Transport culture medium, immunoelectrophoretic equipment, Biological stains
  • Subject to General Controls (Regulatory Requirements which apply to all medical devices) all covered under a quality management system:

    – Registration of producers of medical devices.
    – Notifications and other remedies e.g. recall.
    – Records and reports on devices e.g. adverse event report.
  • Manufacturers are still visible to FDA and may be subject to audit.
  • Devices may be exempted from a General Control as stated in the classification regulation for that device e.g. they may be exempt from GMP other than keeping records and complaint files.
  • Devices are submitted via the 510K pre-market notification process but some are exempt.

Class II

  • Moderate to High Risk e.g. Blood Culture Assay, Rubella ELISA Test
  • Subject to General Controls and Special Controls:
    – Device specific
    – Evidence of meeting performance standards
    – Post market surveillance
    – Adherence to guidelines
    – Special labelling requirement
  • General Controls are considered insufficient to provide assurance of safety and effectiveness.
  • Devices are submitted for pre-market notification via 510K process.

Class III

  • High Risk e.g. Cancer Biomarker companion diagnostic assay
  • Subject to General Controls and Premarket Approval:
    – Quality Management processes and controls
    – Software design, development and cyber security
    – Analytical Verification data
    – Clinical Performance Data
  • Pre-Market Approval (PMA) application is required

Recent Developments

In January 2024, a press release from Jeff Shuren, the director of the Centre for Devices and Radiological Health (CDRH) announced the intent to initiate the reclassification process for most IVDs which are currently class III (high risk) into class II (moderate risk). They identified that the majority of these tests are infectious disease and companion diagnostic IVDs. This is in line with the FDA least burdensome approach allowing manufacturers of some devices to seek marketing clearance through the 510K premarket notification route. In the release it also talked to the FDA desire to encourage more manufacturers to develop the test and in turn increase competition and access to these important tests.

The process of reclassification has already started with a panel meeting in September 2023 identifying 3 types of infectious disease diagnostic IVDs

  • Nucleic acid and serology based IVDs to aid diagnosis of Hepatitis B Virus infection and management of infected patients.
  • Serology based IVDs for detection of human parvovirus B19.
  • Cell mediated immune reactivity IVDs to aid identification of in vitro responses to peptide antigens associated with TB infection.

Conclusion

The IVD industry can only welcome these moves by the FDA in conjunction with the amendment of the Quality Management System regulation (QMS) to be more closely aligned to the ISO 13485:2016 standard. It makes the USA a far more inviting prospect for initial market authorisation applications. The costs are transparent, the timelines are clearly identified and there is a process in place to present and discuss the device with the FDA in a pre-submission meeting.

There are however other considerations that need to be taken, Jeff Shuren has recently announced his retirement and Dr Michelle Tarver will assume the role of CDRH Acting Director. Also, there are presidential elections this year, will these changes impact the current trajectory of the CHRH? We at IVDeology will continue to monitor the situation across the pond, it is evident that since Brexit the UK government has been eager to foster recognition of other regulatory body approvals and it does feel that the movement of the FDA approval process is going in the same direction as that of the UK MDR.

Next steps to consider, and how we can help.

IVDeology Ltd can support with all of the above, please contact us for a friendly conversation to identify how we can support you with your compliance journey via our contact page

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A QMS isn’t just for IVDR conformity assessment…. it’s for life!

In this blog we are going to discuss our views on the benefits and need to have and maintain your Quality Management System (also known as a ‘QMS’)

IVDeology have decades of experience supporting IVD companies and manufacturers all across the globe with their Compliance journey within Quality and regulatory, and Jo Angell, our Quality and operations coordinator at IVDeology talks about the importance of a QMS that can grow with you, having experienced managing IVDeology’s own Quality management system internally at IVDeology as well as setting up and hosting other companies QMS.

What is a QMS?

  • Quality is defined as the “degree to which a set of inherent characteristics of an object fulfils requirements” [ISO 9000:2015, 3.6.2]
  • A management system is a set of interrelated or interacting elements of an organization to establish policies and objectives, and processes to achieve those objectives. [ISO 9000:2015, 3.5.3]

The 2 main standards covering QMS for Medical Device (including In Vitro Diagnostic (IVD)) manufacturers are:

For medical laboratories, where IVDs are used or developed as a Lab Developed Test (LDT) the additional ISO 15189:2022 Medical laboratories — Requirements for quality and competence, can be utilised.

Why have one?

It is true that establishing and maintaining a Quality Management System requires additional investment, both financially and from a resource perspective, there are substantial benefits for having one:

  • Demonstrates to customers your commitment to quality
  • Standardisation of processes
  • Consistent training throughout the organisation
  • Ensures continuous improvement
  • Improved productivity and efficiency
  • Reduced waste steps
  • Improved customer satisfaction
  • Ensures controls are in place to make safe and effective products
  • Identification and control of risks
  • Control and assessment of suppliers

An effective QMS can provide a solid foundation of quality and safety in a consistent and well-organised ecosystem

You will need one if you are intended to place IVDs on market

For the EU the IVDR states that: “all manufacturers should have a quality management system and a post market surveillance system in place which should be proportionate to the risk class and type of device in question”

As a legal manufacturer of an IVD or medical device a QMS must be implemented and compliant to the applicable regulations where you place your device on market. For EU CE marking under the new IVDR transitional timelines,  this shall be no later than 25th May 2025. This is less than 12 months away!

Who’s responsible for maintaining the QMS?

Typically, this is the role of the Quality contact in any organisation. However, establishing a quality culture, and ensuring the QMS has been built, and maintained effectively is the role of the organisations top management. They need to demonstrate leadership and a commitment to the QMS.

Maintaining your QMS

A good and efficient QMS supports your company with the best way to do things, by having input from across the organisation these processes can be agreed on and will be committed by everyone in your organisation. An effective QMS should be everyone’s objective, not just Quality!

A QMS should grow as your organisation grows

A QMS is not a one size fits all, it needs to build and grow with your organisation and will never be a finished article, it should always be continually improving. The complexity and scope should also reflect the nature and size of your organisation.

eQMS are great but…

Electronic QMS software provide a great tool, but you need to build the QMS with you in mind. These will never be an off the shelf ready to go package. All templates will need to be customised and adapted to fit your organisation and processes, otherwise the QMS just won’t work.

You have the certificate and placed the product on market – but what next?

In a previous blog, we discuss the challenge of Post Market Surveillance, and what is expected , mainly from a UK point of view:

“The manufacturer shall institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase and to implement appropriate means to apply any necessary corrective actions, taking account of the nature and risks in relation to the product.”

This means that as manufacturers you still need to be collecting data on how effective your device is – monitoring your customer complaints and feedback, any incident reporting, your manufacturing information, looking at your trends, to mention just a few possible sources of information. This data should then be reviewed to determine whether any updates are required and if so, these actions should be documented appropriately. Potential updates could impact your:

  • Risk Management File – Is the Severity of the risks impacted? Does it impact your frequency of occurrence of known risks? Are there new risks that you haven’t included?
  • Instructions for Use & Labelling – Do you need to add additional warnings? Are your instructions clear enough?
  • Training – Is any training that you provide sufficient? Is additional training necessary for your users?
  • Other products – Does the issue impact other devices you manufacture

5 Top Tips from the team on how to effectively build and maintain a QMS

  1. Get buy in from senior management – if they don’t understand what a QMS is, and why it is important (and not just required), it will never be supported and managed effectively.
  2. It is a growing, living thing, the more you feed it, the stronger and more robust it will be. It needs love and attention to get the most out of it.
  3. QMS software will save you time and money in the long run.
  4. Most non-conformances are raised against your own processes, not the standard. Make your procedures as simple and as clear as possible, ensure the people doing the work are involved in creating the processes, they know their processes the best!
  5. Use internal audits to strengthen and improve your QMS and use your business risk assessments as a tool to help the business overcome challenges and move on new opportunities

If you’ve got this far, you’ll hopefully understand the importance of a fully functioning and certified QMS but may be worried about where to start. At IVDeology (an Abingdon Health company) we offer full service solutions for QMS amongst our nose-to-tail regulatory support services. We can support you by:

  1. Being Legal Manufacturer (all QMS responsibility lies with us)
  2. Build your QMS for you
  3. Host your QMS within our ISO certified system or we can put you in touch with Cognidox, a QMS system we use at IVDeology ourselves

Our team of experts have a proven track record for the development and maintenance of Quality Management System ranging from SME to large IVD manufacturers. To hear more about how we can support, please contact [email protected] or click ‘get in touch’ to book in with our customer success coordinator

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Performance Evaluation: The critical component in bringing your product to market and keeping it there

Abingdon Health and IVDeology Ltd have decades of  In-Vitro Diagnostic (IVD) regulatory compliance experience where our teams support your entire product journey from ‘cradle-to-grave’ to ensure you are getting your product to market in the quickest timeframe possible, reducing cost and strain, and keeping it compliant through its lifetime.

Abingdon Health also offer full-service contract development and manufacturing for lateral flow assays, bringing your idea to commercial success, with the benefit of an integrated regulatory and quality approach.

In our latest blog, Candice Vendettuoli Head of RAQA at Abingdon Health covers the importance of getting your Performance Evaluation (PE) right to streamline your route to market, and ensuring compliance to keep it there.

What is Performance Evaluation?

The In Vitro Diagnostic Regulation (IVDR) 2017/746, which entered into force in May 2017 and applied in May 2022, has introduced significant changes to the way in vitro diagnostic (IVD) medical devices are regulated in the European Union. One of the key aspects of this regulation are the new requirements for documenting the performance evaluation of IVD medical devices using a prescriptive document structure mandated within the Regulation.

Performance evaluation under IVDR is expected to be a continuous process throughout its entire lifecycle of the device. This process is crucial for ensuring that the device meets upon entry to the market, and continues to meet, the intended clinical benefits and safety as claimed by the manufacturer.

The mandated documents should be written to provide a comprehensive and structured narrative for the reviewer giving a clear and logical explanation of how the device was developed, verified and validated against the intended use/purpose claimed by the manufacturer. These documents are a requirement of the Technial Documentation described in Annex II and forms an essential part of the submission to the Notified Body

The mandated documents, unless they can justify why such studies are not applicable are as follows:

Performance Evaluation Plan

Ideally written during the early development of the device and updated regularly, this document has content prescribed within Annex XIII section 1.1 of the Regulation. Manufacturers are required to establish and regularly update the performance evaluation plan that outlines the device’s characteristics and performance, as well as the process and criteria used to generate the necessary clinical evidence.

Scientific Validity

The concept of scientific validity under the In Vitro Diagnostic Regulation (IVDR) 2017/746 is a cornerstone in the performance evaluation of in vitro diagnostic (IVD) medical devices. It refers to the association of an analyte with a clinical condition or physiological state, which must be substantiated with a medical-scientific rationale evidenced through a systematic literature search

Analytical Performance

Analytical performance refers to a device’s ability to accurately and reproducibly measure an analyte, marker, or molecule, which is a strictly technical performance without the need for correlation with a targeted pathology.  There are analytical performance characteristics mandated within Annex I section 9.1(a) including assessing the accuracy, sensitivity and specificity,

Clinical Performance

Clinical performance is defined as the ability of a device to yield results that are correlated with a particular clinical condition, physiological or pathological process, or target population and intended user. Manufacturers must demonstrate clinical performance through one or more of the following:

  • Clinical performance studies, carried out according to the IVDR requirements on clinical performance studies described in Articles 57-77, Annex XIII section 2 and, if applicable, Annex XIV for studies other than those using leftover samples
  • Scientific peer-reviewed literature on the device under evaluation, or
  • Published routine diagnostic testing.

Performance Evaluation Report

The report (also known as a ‘PER’) provides a summary of the clinical evidence collected through the previous reports. An assessment can then be made against the current state of the art in diagnostics and medicine that a positive benefit-risk ratio of using the device for its intended purpose has been met and then all data has been collected.

This rigorous approach ensures the reliability and effectiveness of in vitro diagnostic devices within the European Union, with the primary aim of protecting public health by requiring high levels of safety and performance of these devices to be evidenced.

For manufacturers, understanding and adhering to the IVDR’s performance evaluation requirements is vital for successful market introduction of their IVDs in the European Market. It involves a comprehensive understanding of the general safety and performance requirements (GSPR), as well as the specific guidelines on performance evaluation stipulated in Article 56 of the IVDR.

Abingdon Health and through its subsidiary IVDeology Ltd , can offer support and guidance to help companies navigate these new and complex EU Performance Evaluation requirements.

We offer a full-service solution for all your regulatory and quality requirements including:

Contact Us today to book some time with one of our industry experts to understand how we can support you bringing your product to market and keeping it there.

 

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IVDeology Partners with MedBoard

Cutting through the Regulatory Noise: Our new partnership with MedBoard

It seems that the medical device regulatory world has gone into overdrive in the last few years. The rate of regulatory change and the demand for clear guidance around them has substantially increased, especially when you focus on the European Union and the UK which are th key areas IVDeology specialise in. It is now getting to the point where one regultory expert simply cannot know everything they need to know, and this is without the peripheral requirements of REACH, CLP, Sustainability, Environmental and Digital. The need to find the right information from a trusted source has never been so important, as well as in a timely manner.

Our Regs Consultant Fiona Thompson commented the following:


“When I left my previous role to start at IVDeology, finding relevant, correct regulatory updates was one of the things I found most challenging. Having come from a large company, this was all done at a Corporate level and at our site we found out information from notifications or changes to the Global procedures sent out. Out of this corporate world, the places I knew where to look for information had all disappeared and trying to find all the potential websites to set up personnel alerts, I will be honest, was very painful – and I’m still sure I haven’t found them all.”

Even from the early days of IVDeology, the aim was to develop a strong team connected to a wide and diverse industry network, which would help us inform our customers on any Quality and Regulatory updates relating to IVDs and Medical Devices. We do this knowing that many of our SME customer don’t have this network themselves and getting the right information can be a very difficult and time-consuming thing.


Recently we have started using a system called MedBoard – and what a game-changer this is!


“MedBoard is a dedicated search engine for the sector. You can set up customised reviews with relevant key words to keep up to date with new regulatory news in specific countries that you are interested in as well as conduct searches for PMS, literature searches etc. It also sends you email alerts when new information is released. What MedBoard does is provide you with a starting point for regulatory intelligence, based on trusted resources, this allows you the opportunity to build your understanding and supplement your existing knowledge network.”

How do we use MedBoard to support our customers?


IVDeology have used the MedBoard subscription services since early 2023 as we personally find the subscription beneficial to cut through the noise and share the industry updates that are tailored and beneficial to our customers.
IVDeology is proud to funnel information down to our customers and recommend MedBoard’s services and be able to add:

a) timely regualatory updates from a trusted source
b) offer insights on the impact of these updates, using our in-depth knowledge of the IVD indsutry

The outcome for this is to give you the ability to make informed decisions, develop strategies and mitigate changes to the IVD industry relevant to your devices and markets.

At IVDeology, we don’t believe these is a one size fits all model for what we do, as we are committed to helping you in the way that works best.

We’re happy to be able to share updates from MedBoard and put you in touch if you wish to sign up individually as a company to be able to personalise the package at which level you wish, as MedBoard offer several layers of package support depending on budget and need including a new artificial intelligence scanning tool as well as software Validation documents approach for QMS/GxPs processes overviews.

IVDeology adds a layer of support to help explain and discuss the updates and how this may affect your company, teams and projects. This sits well alongside our existing compliance services including UK Responsible Person (UKRP), Person Responsible for Regulatory compliance (PRRC), training, ad-hoc and project support. You can find more about these services on our website.


And to support one step further, IVDeology have a certified team of Quality experts in ISO9001 and ISO13485 to help with implementation of QMS systems and remediation, including software validation.


We don’t make anything from sign ups, we just really think the tool is an excellent creation, and side by side we can create a support system of clear updates whilst also breaking it down into easy digestible actions which saves you valuable time.

For further information or a demonstration on how we can help you, please book a call with Casey or drop us an email at [email protected] to know more.