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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Influenza Assays: Risk Classification Under IVDR

July 27, 2023

New position statement published by the IVD expert panel on influenza viruses

MDx CRO, an IVD consultancy and CRO company, reviews the latest position paper published by the EU Commission IVD Expert Panel. The publication discusses the risk classification of influenza assays under the In Vitro Diagnostic Regulation (IVDR) and focuses on whether influenza viruses should be considered as high-risk Class D pathogens or fall under other risk categories.

Background

Influenza viruses, like many respiratory viruses, have the potential to cause life-threatening diseases with a high or suspected high risk of propagation. The severity and transmissibility of an influenza virus strain depend on various factors, including virus-specific, host-specific, and environmental factors. Seasonal influenza strains undergo antigenic drift, while antigenic shift can result in new influenza A subtypes, potentially leading to pandemics.

Transmissibility and Severity

Transmissibility is a key indicator of the ease of movement of the influenza virus between individuals and communities. It is influenced by the virus’s ability to spread from person to person, transmission dynamics, and population susceptibility. Influenza viruses can be transmitted not only between humans but also from animals to humans and vice versa, posing public health risks.

Disease Severity of Influenza A(H1N1)pdm09

The A(H1N1)pdm09 strain, responsible for the 2009 pandemic, was remarkably different from seasonal influenza strains, leading to a higher fatality rate and impacting younger populations more severely. Since the pandemic, A(H1N1)pdm09 has continued to circulate, causing significant disease burden globally. Despite available vaccines, their effectiveness remains a concern, and oseltamivir-resistant variants have been reported. Ongoing global surveillance and analysis of antiviral susceptibility are crucial for public health and patient care.

Other Circulating Influenza Virus Strains

Various seasonal influenza viruses, both type A and B, have the potential for high transmissibility and severe disease. An unusual and severe epidemic was observed during the 2017-2018 season, primarily dominated by influenza B virus, while influenza A(H3N2) and A(H1N1)pdm09 also caused severe cases in older adults. Additionally, zoonotic transmission of novel influenza strains, like H3N2, H7N9, and H5N6, has been reported, highlighting the importance of global surveillance and early warning systems.

Feasibility of Developing General Common Specifications for influenza assays

Given the unpredictable changes in influenza strains and the potential for novel variants to emerge, it is challenging to develop general common specifications with minimum performance requirements for class D devices. Assays for seasonal influenza detection, intended for individual infection detection, may not be suitable for detecting emerging strains with pandemic potential or from non-human origins. Such assays may require different safety protocols and risk assessments, and rapid confirmatory real-life performance evaluation studies should be considered.

Risk classification of influenza assays under the IVDR

Influenza viruses, particularly A(H1N1)pdm09, have demonstrated the potential for high transmissibility and severe disease, leading to significant public health consequences. The development of general common specifications for all influenza strains is challenging due to the varying risks and objectives associated with different assay types. With regards to the risk classification of influenza assays under the IVDR, the Commission’s position paper points out that seasonal influenza assays should be classified as class C devices, while class D devices may be necessary for assays intended to detect strains with pandemic potential or from non-human origins. This position statement may contradict some of industry’s initial assumptions on the classification of devices for seasonal influenza. V2 of the MDCG guidance on classification rules for IVDs originally stated that a “device intended for the detection of influenza A/B virus (non pandemic)” was a class B device according to rule 6.

Implications for manufacturers of influenza assays

The classification of IVDs can be highly intricate, and determining whether a device should be classified as Class B or Class C (and even D) often presents challenges. This complexity is particularly evident in devices where the associated risk level varies between low, moderate, and high, depending on factors such as circulating strains and the intended use of the device.

Notified Bodies have been adhering to the MDCG classification guidance to classify these devices and grant appropriate certification according to the risk class. For instance, assays designed to detect seasonal influenza were typically considered Class B devices, following examples provided in the guidance. On the other hand, assays intended for detecting high-risk strains would be classified as Class D (also according to the guidance).

This classification approach seemed logical until the latest advice from the expert panel was published. According to this updated advice, seasonal influenza assays could potentially be reclassified as Class C devices. This reclassification would have significant implications for manufacturers, as it would require the creation of Periodic Safety Update Reports (PSURs), Summary of Safety and Performance (SSP) documents, and other additional scrutiny throughout the entire process.

Given these potential changes, MDx CRO and relevant stakeholders are intrigued to learn how Notified Bodies will respond to this new development and what their expectations will be moving forward. Manufacturers may need to adapt their strategies to comply with a potential revised classification and the increased requirements, which may present both challenges and opportunities in the IVD industry.

Ongoing global surveillance, international collaboration, and data sharing are essential for effective influenza control and preparedness.

MDx CRO has extensive experience in conducting clinical performance studies and providing regulatory support for high-risk infectious disease IVDs.

Contact our team today to initiate a discussion!

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 Compliance: Progress in EU Reference Laboratories and consequences for High-Risk IVDs

June 22, 2023

EU Commission evaluates EURLs

The European Commission is making significant progress in evaluating applications for EU reference laboratories (EURLs) to ensure compliance with the In Vitro Diagnostic Medical Devices Regulation (IVDR). These designated laboratories play a vital role in upholding the safety and efficacy of high-risk in vitro diagnostic medical devices (IVDs) within the European Union (EU).

In accordance with Article 100 of Regulation (EU) 2017/746, the Commission has been diligently assessing the applications received for EURL designation. The EURLs are entrusted with key responsibilities related to IVDR compliance, including advisory roles and activities associated with market access, specifically for class D devices that carry the highest level of risk. These laboratories are responsible for verifying the performance and ensuring the conformity of class D devices with common specifications, as well as conducting batch testing.

While no EURLs have been designated under Regulation (EU) 2017/746 thus far, the European Commission launched a call for applications in July 2022, targeting eight categories of class D devices. These categories encompass various areas such as hepatitis and retroviruses, herpesviruses, bacterial agents, arboviruses, respiratory viruses causing life-threatening diseases, haemorrhagic fever and other biosafety level 4 viruses, parasites, and blood grouping.

Candidate laboratories were invited to submit their applications to the national contact points in their respective Member States by January 2023. Subsequently, Member States were responsible for submitting the applications on behalf of the candidate laboratories to the European Commission, with a deadline of March 31, 2023.

8 Laboratories apply for designation

As of the deadline, the European Commission has received eight applications for review. These applications are currently undergoing a comprehensive assessment based on the specific criteria outlined in the call for applications. The evaluation process ensures that applicant laboratories meet the necessary standards and possess the combined capacity to handle the expected volume of requests related to market access tasks.

The European Commission aims to conclude its assessment process by the third quarter of 2023. However, it has been determined that none of the applicant laboratories in the category of haemorrhagic fever and other biosafety level 4 viruses possess the required combined capacity to adequately address the anticipated volume of requests. Consequently, no EU reference laboratory will be designated for this particular category following the current call for applications.

Despite the absence of a designated EURL, manufacturers can still pursue conformity assessment of their IVDs through notified bodies, allowing for certification and lawful placement of products on the EU market in adherence to Regulation (EU) 2017/746.

It is important to note that additional calls for EURLs in the field of IVDs may be issued in the future, and relevant information will be published in advance to facilitate preparedness among stakeholders.

For detailed guidance on the integration of EURLs into the conformity assessment process once they are designated, manufacturers are encouraged to refer to MDCG 2021-4.

The establishment of EU reference laboratories marks a significant stride towards enhancing IVDR compliance and ensuring the quality and safety of high-risk IVDs across the European Union. The European Commission’s thorough evaluation process and steadfast commitment to regulatory compliance are instrumental in safeguarding public health and fostering innovation in the field of in vitro diagnostics.

MDx CRO: Your Partner for High-Risk IVD Studies

Looking to navigate the stringent requirements of EU common specifications and EURL standards?

Partner with MDx CRO. Our expert team specializes in designing and conducting IVD studies that meet these rigorous demands.

We offer:

Customized Study Design: Tailored protocols aligned with high-risk IVD requirements, common specifications and EURL expectations.
ISO 20916 Clinical Performance studies in state-of-the-art EU laboratories: Accurate and reliable studies to demonstrate IVD clinical performance.
Regulatory Compliance Support: Expert guidance throughout the regulatory journey
Quality and Timeliness: Efficient execution, precise data collection, and timely reports.

With MDx CRO as your ally, achieve IVDR compliance and bring your high-risk IVDs to market confidently.

Contact us today to discuss your needs and ensure a predictable go-to-market strategy.

FAQs

Q: What tasks do EU Reference Laboratories (EURLs) perform?

A: EURLs have a range of important tasks designed to ensure effective IVDR compliance. These tasks include:

Verification of performance: EURLs verify the performance claimed by manufacturers and ensure compliance with Common Specifications or other solutions.
Testing of devices: EURLs perform tests on samples of manufactured class D devices or batches of class D devices to ensure their quality and safety.
Scientific and technical assistance: EURLs provide valuable scientific and technical assistance, opinions, and advice to support regulatory decision-making.
Network management: EURLs establish and manage networks and sub-networks of reference laboratories to facilitate collaboration and exchange of knowledge and expertise.
Development of testing methods: EURLs contribute to the development of appropriate testing and analysis methods for IVDs, promoting standardized practices.
Collaboration with notified bodies: EURLs collaborate with notified bodies to develop best practices and ensure consistency in conformity assessment procedures.
Recommendations on reference materials: EURLs provide recommendations on suitable reference materials and measurement procedures to enhance accuracy and reliability.
Contribution to standards development: EURLs actively participate in the development of Common Specifications (CS) and international standards to align regulatory requirements.

Q: Are EURLs only for class D devices?

A: While EURLs are primarily intended for class D devices, there is provision for an EU reference laboratory to be assigned for class C devices upon request from a Member State.

Q: What is the purpose of creating a network of laboratories across the European Union?

A: The aim is to establish a broad network of laboratories throughout the European Union to enhance the safety and compliance of the IVD market. These laboratories will adopt harmonized methods, ensuring coordinated processes, consistent testing protocols, and standardized reporting. They will also cooperate in quality assessment tests, develop joint guidelines, and coordinate the introduction of testing methods for emerging technologies.

Q: How will EURLs contribute to making the IVD market safer and compliant?

A: EURLs play a crucial role in verifying device performance, conducting rigorous testing, and providing scientific expertise. By adopting harmonized methods and collaborating within the network, EURLs ensure consistency, accuracy, and reliability in the assessment of IVDs. This ultimately contributes to a safer and more strictly IVDR compliance framework within the European Union.

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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Companion diagnostic studies: BSI & TÜV SÜD Lead the Way in CDx Certification

June 6, 2023

The field of personalized medicine is experiencing notable progress as BSI and TÜV SÜD, two of the largest Notified Bodies in the European Union, have issued their first Companion Diagnostic (CDx) Certificates under the In Vitro Diagnostics Regulation (IVDR). This achievement carries substantial implications for manufacturers of in vitro diagnostics (IVD) and Contract Research Organizations (CRO) such as MDx CRO. MDx is a specialized IVD CRO with expertise in conducting clinical performance studies, including companion diagnostic studies, as stakeholders adapt to the changing landscape of CDx.

Key Milestone Reached: 1st IVDR CDx Certificates Officially Issued

BSI The Netherlands (2797) issued its first CDx certificate in May, 2023, to Invivoscribe, Inc. for their LeukoStrat® CDx FLT3 Mutation Assay, a vital tool in tailoring treatment for acute myelogenous leukaemia (AML) patients with FLT3 ITD and TKD gene mutations.

Earlier, TÜV SÜD Product Service GmbH had made its mark as the issuer of the world’s first CDx certificate in accordance with the IVDR, awarded to Roche Diagnostics GmbH for a qualitative immunohistochemical cancer biomarker assay. This assay detects the programmed death-ligand 1 (PDL1) expression pattern, enabling identification of patients who will benefit most from a specific therapeutic treatment.

The milestones reached by Invivoscribe, Inc. and Roche Diagnostics GmbH signal to other manufacturers the effectiveness of the IVDR regulatory framework in certifying these devices. Furthermore, it testifies to the successful collaboration between manufacturers, EMA, and Notified Bodies, paving the way for similar certifications in the future.

Understanding the Impact of IVDR on Companion Diagnostics

Companion diagnostic devices like these are key in advancing personalized medicine, as they are clinically validated to determine patients’ likelihood of responding to a specific treatment. However, the enforcement of the IVDR has increased the regulatory oversight for these devices, pushing most into risk Class C, necessitating Notified Body review prior to being placed on the market.

The IVDR’s new risk classification concept has expanded the role of Notified Bodies like BSI and TÜV SÜD, requiring them to oversee more than 80% of IVD devices, a significant rise from the previous 10-15% under the IVD Directive. These regulatory changes underscore the value of experienced CROs like MDx CRO in supporting manufacturers through this intricate process.

Under the IVDR, CDx products, once free from Notified Body involvement, are now classified as Class C and must undergo a Notified Body conformity assessment. This process requires consultation with the European Medicines Agency (EMA) or the Competent Authority (CA) for medicinal products, as per the 2001/83/EC directive, which lengthens the overall conformity assessment process. Manufacturers must factor in this increased timeline, especially with the IVDR requiring Class C CDx products to be CE-marked by May 2026.

Choose MDx CRO for Reliable Companion Diagnostic Studies

As a trusted IVD CRO partner, MDx, with its extensive experience in managing IVD clinical performance studies including companion diagnostic studies, is equipped to assist clients through the evolving CDx and regulatory landscape. By optimizing innovative diagnostic solutions and ensuring full regulatory compliance in our CDx clinical trials, we strive to contribute to the delivery of top-tier personalized medicine, enhancing patient care worldwide.

Contact us today to learn how MDx CRO can partner with you to help bring your companion diagnostic to market.

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New Regulation on In Vitro Diagnostic Medical Devices in Spain: Are You Ready?

June 2, 2023

Are you ready for the new regulation on In Vitro Diagnostic medical devices in Spain? Learn everything you need to know about it.

The in vitro diagnostic medical device sector plays an important role in healthcare by providing instruments and solutions for illness diagnosis and monitoring. Regulatory agencies regularly update and adopt new regulations to maintain the safety and effectiveness of these products.

Recently, the public consultation process for the new regulation on In Vitro diagnostic medical devices in Spain, replacing the previous Royal Decree 1662/2000, has been completed.

The proposed text’s draft can be accessed on the website of the Spanish Ministry of Health. The new decree aims to adopt the required regulatory measures in areas where Regulation (EU) 2017/746 allows member states to establish national regulations.

These regulations address key aspects such as manufacturer licensing, clinical studies, and the production of in vitro diagnostic devices for exclusive use in healthcare facilities.

New Regulation on In Vitro Diagnostic Medical Devices: 5 Key aspects

1. Operating License

The new regulation on In Vitro diagnostic medical devices, like the previous one, requires manufacturers, importers, and now those who make finished products for third parties to get a prior operating licence.

To assure product quality and the execution of key procedures and controls, manufacturers must have a quality management system in place. They must also have suitable facilities, procedures, equipment, and personnel for the corresponding activities and products.

The new regulation maintains the figure of the technical responsible person, who must have a minimum higher education degree.

Although the requirements and duties of the technical responsible are not the same as those of the personnel responsible for regulatory compliance as set out in Regulation (EU) 2017/746, they may be covered by the same person if they meet all the requirements.

2. Registration and Marketing Obligations

The second key aspect of the new regulation for In Vitro diagnostic medical devices makes a reference to registration and marketing obligations.

Before beginning their activities, any economic operator seeking to market products in Spain has to register in the Commercialization registration of the Spanish Agency of Medicines and Medical Devices.

Economic operators must keep written records of the products they make available in Spain and must notify the regulator of any changes in this information or cessation of activity. This registration is required to assure the traceability and safety of the product.

Economic operators must disclose information in Spanish if health authorities make a justified request, but they may submit documentation in other languages to demonstrate product conformity. Importers and distributors must get the necessary documentation from the manufacturer or authorised representative if it is not available.

The new regulation for in vitro diagnostic medical devices mandates the creation of a document archive system to store the documentation generated for each product and to keep a record of all products for traceability purposes.

Manufacturers must make the records available to relevant authorities for at least ten years following the product’s last market release, even in extreme situations such as bankruptcy or the suspension of business.

These requirements ensure that manufacturers maintain rigorous control over the quality and safety of their products and facilitate supervision by authorities. It is important to note that some of these obligations do not apply to pharmacies, as they have their own records.

3. In-House Product Manufacturing

The manufacturing of in-house products in health institutions is subject to strict regulations under the new regulation for in vitro diagnostic medical devices to ensure product safety and quality. In line with Regulation (EU) 2017/746, the new text recognizes that all health institutions can carry out the manufacturing of in vitro diagnostic devices for exclusive use within those centres, not limited to hospitals as it is the case with medical devices.

However, to do so, they must comply with all the requirements established in Article 5(5) of the Regulation (EU) 2017/746. It is important to mention that health institutions cannot subcontract manufacturing outside Spanish territory.

Additionally, they must designate a responsible person for manufacturing procedures and communicate their data to the Spanish Agency of Medicines and Medical Devices. This ensures traceability and regulatory compliance in the manufacturing process.

The sale of products manufactured in these centres to the public or third parties is not permitted. Moreover, health institutions must provide prior communication of the start of manufacturing activities, providing detailed information and complying with the required documentation.

The agency can conduct subsequent verifications and inspections to ensure compliance.

4. Performance Studies

The new regulation for in vitro diagnostic medical devices addresses the requirements and procedures related to clinical performance studies in the field of in vitro diagnostic medical devices. Ethical and subject protection principles must apply to these studies.

Products intended for clinical performance evaluation studies must receive approval from the Research Ethics Committee and the centre’s management before they can begin. Interventional clinical performance studies and other functional performance studies involving risks to test subjects require authorization from the AEMPS (Spanish Agency of Medicines and Medical Devices).

The text establishes provisions regarding documentation, product supply, insurance, compensation for damages, and liability regime for sponsors.

5. Market Surveillance and Control

The system of market surveillance and control is essential for ensuring the safety and quality of in vitro diagnostic medical devices according to the new regulation for in vitro diagnostic medical devices.

Manufacturers, healthcare professionals, authorities, and users play a crucial role in this process, working together to protect public health and ensure regulatory compliance.

Manufacturers must report incidents in accordance with established protocols. Additionally, healthcare professionals, authorities, and users have the responsibility to report serious incidents to the Spanish Agency of Medicines and Medical Devices. Health institutions must designate a surveillance responsible person and communicate their data to the relevant health authorities.

Manufacturers must also report safety corrective actions and provide information in Spanish to ensure effective dissemination. The Spanish Agency of Medicines and Medical Devices coordinates market control activities in collaboration with regional health authorities, including periodic inspections.

Other specific aspects and details are regulated by this regulation, such as the use of products that have not yet demonstrated conformity or aspects related to genetic testing.

It is important underlying the significance of regulatory compliance and quality in the manufacture of these products, as well as how a regulatory, quality, and clinical consultancy service organisation may be a strategic ally in this highly regulated and ever-changing environment.

We must be prepared to comply with the royal decree once the parliamentary procedures are concluded and the new regulation for in vitro diagnostic medical devices is authorised.

How can MDx CRO help?

Are you finding it challenging to navigate the complexities of the new in vitro diagnostic medical device regulations in Spain? Is the realm of IVD consulting seeming increasingly vital to your business? Look no further than MDx CRO, your dedicated partner in this journey.

With a team of experienced IVD consultants, we provide robust solutions for regulatory, quality, and clinical consultancy services tailored to your needs. As your IVD consultancy partner, we offer comprehensive assistance in manufacturer licensing, clinical studies, and production compliance, ensuring your business aligns seamlessly with the new Royal Decree and Regulation (EU) 2017/746.

Don’t let regulatory hurdles stand in the way of your company’s success. Embrace the change, and navigate this evolving landscape with confidence and ease by leveraging MDx CRO’s expertise.

For a no-obligation discussion on how we can assist you in maintaining your market competitiveness within the IVD sector, contact us today. Let us be your strategic ally in this highly regulated environment, ensuring your continued growth and success.

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