Resources Sector: IVDs

IVD Regulatory Services by MDx CRO

August 9, 2023

At MDx CRO, our specialized IVD regulatory services cater not only to in vitro diagnostic medical device manufacturers, but also companion diagnostics (CDx). Moreover we work with companies and their pharma partners, laboratories, suppliers, IVD subcontractors and more. Our in-depth knowledge and expertise make us stand out in the constantly evolving landscape of IVD regulations.

Why Choose MDx CRO for IVD Regulatory Services?

  • IVD Compliance Mastery: MDx CRO assists IVD manufacturers throughout the entire product life cycle. We ensure you achieve and maintain compliance with IVD regulations across various countries.
  • Regulatory Expertise: We not only understand the EU IVDR regulation but are also proficient in the transition from IVDD to IVDR, the FDA IVD requirements in the US, and pre-submission reviews. This comprehensive know-how ensures your product’s smooth and swift entry into the US and EU medical device markets.
  • Tailored Services: Be it a start-up, SME, or multinational company, MDx CRO’s bespoke IVD consultancy services are designed to meet your unique needs.

Our IVD Regulatory Service Spectrum

  • New Device Development: We guide you through design, development, and market access strategy formulation based on your intended purpose.
  • Regulatory Transitions: Navigate the shifts from IVDD to IVDR effortlessly with our expert insights into necessary requirements and adjustments.
  • Market Expansion: From the US FDA to EU-IVDR, our regulatory submission support ensures you comprehend and meet the distinct requirements of global markets.
  • Commercialization Support: MDx CRO ensures that your device meets all prerequisites for commercial distribution, including device labeling, training materials, and regulatory submissions.

Engage with Seasoned Experts in Regulatory services

Our specialists, equipped with industry-centric design and development skills fused with regulatory acumen, are here to provide unparalleled guidance. IVD analytical and clinical performance support can significantly benefit from our specialized expertise.

IVD Manufacturers’ Guide

  • IVD Regulatory Strategy: We assist in devising the most fitting regulatory approach for your IVD products with our unique IVD roadmap solutions.
  • IVD Technical File Support: Let us help in completing or reviewing your IVD Technical Files to ensure full compliance with the IVDR (EU) 2017/746, paving the way for a hassle-free CE-IVD approval.
  • Gap Analysis: Gauge the difference between your Quality Management System and IVDR (EU) 2017/746 requirements to stay ahead.
  • Mock & Supplier Audits: Be audit-ready always with our comprehensive audit services, including our IVDR pre-submission service.

Embracing Quality and Excellence by MDx CRO

At MDx CRO, quality is our benchmark. Our global team, adept at vendor auditing for diagnostic and laboratory partners, ensures QMS audits in compliance with globally recognized standards.

MDx CRO’s integrated approach, assures sponsors of audit compliance, helping them prepare for any potential international regulatory inspections.

Join forces with MDx CRO and navigate the intricate world of IVD regulations with confidence. Let’s embark on this transformative journey together!

Contact us today to discuss your project needs!

Industry Insights & Regulatory Updates
ISO 10993-1:2025 From Checkbox Compliance to Risk-Based Biocompatibility

ISO 10993-1:2025 From Checkbox Compliance to Risk-Based Biocompatibility
Making IVDR Work in Combined Studies: Scientific & Operational Lessons from 40+ Programs

Making IVDR Work in Combined Studies: Scientific & Operational Lessons from 40+ Programs
ISO 14155:2026 What’s Changed and What It Means for Your Clinical Investigation

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Portugal’s New Clinical Trials Law No. 9/2026: What Sponsors Need to Know

Portugal’s New Clinical Trials Law No. 9/2026: What Sponsors Need to Know
IMDRF Draft N91 2026: New Clinical Evidence Requirements for IVDs Explained

IMDRF Draft N91 2026: New Clinical Evidence Requirements for IVDs Explained

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

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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IVD Consultancy: Balancing Expertise & Cost-Efficiency with MDx CRO

July 27, 2023

Striking a balance between expertise and cost-efficiency in IVD consultancy can be a tricky task, especially within the European Union’s context, where there’s a notable dearth of specialized consultants. Recognizing this challenge and its impact on your business’s success is what we do at MDx CRO. This article offers a deep dive into the crucial factors to bear in mind when picking your IVD consultant and how MDx CRO combines expertise and cost-effectiveness smoothly.

Selecting a consultant should be a process that considers a variety of factors aligned with your company’s unique needs and budget. Here’s a look at some of the most important aspects, including domain expertise, relevance to the industry, cost-effectiveness, and cultural fit.

Depth of Expertise

At the heart of a successful IVD consultancy engagement is a consultant’s profound and extensive knowledge. This is especially important in a specialized area like IVD, where the regulatory terrain is complex and quite different from general medical devices. Scrutinize potential consultants’ qualifications, industry experience, and roles within IVD companies, regulatory bodies, and regulators to ascertain they possess the necessary domain expertise. At MDx CRO, we value expertise and consider its cost justified by the immense value it brings to your project. Our consultants are not just well-versed in the IVD sector; they are seasoned professionals with a wealth of practical experience. A common error is opting for a consultancy firm with a general understanding, perhaps in areas like pharma or general medical devices. If you’re not engaging with a partner and consultants with a deep understanding of your specific IVD technology, you’re essentially laying down hurdles in your own path.

Industry Relevance and Recommendations

It’s crucial to check how up-to-date and applicable the consultant’s knowledge is. Review their published works, evaluate their communication style, and verify if their insights align with your needs. Moreover, consider seeking industry colleagues’ recommendations or checking professional networks like LinkedIn. A reputable consultant should be able to give a rundown of their services, providing a clear view of their value proposition and balance of cost and benefits.

Comprehensive Service Offering and Cost-Efficiency

Depending on your market entry strategy, you might require a consultant with expertise in your target regions. Consultants adept in navigating both EU and US regulatory landscapes can deliver significant value, providing cost-efficiency by producing uniform documentation for multiple markets. This saves time and eliminates redundant tasks. At MDx CRO, we take pride in offering such comprehensive and cost-effective services, positioning ourselves as your all-in-one solution for IVD regulatory needs.

Cultural Compatibility

While often overlooked, a strong cultural fit plays a crucial role in a successful collaboration. An open conversation with potential consultants can help you gauge this compatibility in terms of language, time zone, and communication style. A good cultural fit promotes better collaboration, yielding more bang for your buck.

In conclusion, choosing the right IVD consultancy involves a careful balance of expertise, industry relevance, cost-effectiveness, and cultural fit. At MDx CRO, we embody this balance, providing comprehensive, cost-effective IVD consultancy services without compromising on value. Our goal is not only to deliver expert solutions but to do so at fair and transparent prices, distinguishing us in the IVD industry.

Feel free to contact us today to discuss your IVD consultancy needs. It’s where our IVD Consultancy Expertise and Cost-Efficiency come into play, ensuring that you receive the best possible value for your investment.

Written by:
Carlos Galamba

Carlos Galamba

CEO

Carlos spent several years of his career at BSI, where he developed a global network of relationships with top EU Notified Bodies. As the first in-house clinician for IVDs at BSI, he led the implementation of the BSI clinical oversight process, providing hundreds of CE marking recommendations for IVDs and supporting IVDR Notified Body designations.
Industry Insights & Regulatory Updates
ISO 10993-1:2025 From Checkbox Compliance to Risk-Based Biocompatibility

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Making IVDR Work in Combined Studies: Scientific & Operational Lessons from 40+ Programs

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ISO 14155:2026 What’s Changed and What It Means for Your Clinical Investigation

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Portugal’s New Clinical Trials Law No. 9/2026: What Sponsors Need to Know

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IMDRF Draft N91 2026: New Clinical Evidence Requirements for IVDs Explained

IMDRF Draft N91 2026: New Clinical Evidence Requirements for IVDs Explained

Clinical Molecular Genetics (CMG) Under the Lens of the EU IVDR, MDCG and MEDDEV.

July 24, 2023

At the crossroads of healthcare and technology, Clinical Molecular Genetics (CMG) emerges as a keystone, bridging molecular biology and genetics to comprehend and diagnose a plethora of diseases. Implementing the European Union’s In Vitro Diagnostic Medical Device Regulation (IVDR) heralds a transformative shift, bringing considerable changes to CMG and the broader landscape of in vitro diagnostics (IVD). This article seeks to demystify the implications of the IVDR for CMG and provide insights into the way forward.

Understanding Clinical Molecular Genetics (CMG)

CMG lies at the heart of modern healthcare, harnessing the transformative power of molecular biology and genetics. The field provides critical insights into a multitude of diseases, from single-gene disorders to complex multifactorial illnesses, thereby informing diagnosis and therapeutic decisions. Rapid advancements, such as next-generation sequencing (NGS) and genomics, continue to drive the evolution of CMG, heralding a promising future of personalized medicine.

The IVDR: A New Regulatory Era

In response to the sweeping advancements in CMG and other IVD fields, the European Union launched the IVDR (EU) 2017/746, which became effective in May 2022. The IVDR offers a comprehensive regulatory framework aiming to ensure patient safety and the accuracy of diagnostic results across all EU member states.

IVDR and Clinical Molecular Genetics: A New Relationship

With the IVDR, several substantial changes are impacting CMG-related IVDs, from manufacturing processes to distribution and usage. The regulation emphasizes post-market surveillance and vigilance requirements, sets rigorous standards for quality management systems, and demands comprehensive technical documentation.

Importantly, genetic tests and high-throughput NGS devices are classified under Class C or D, indicating a higher risk level. This classification necessitates a thorough review by a Notified Body, making IVDR compliance an integral part of CMG operations.

CMG, MEDDEV and MDCG: Guiding Lights in the Regulatory Landscape

EU’s guidance documents for CMG, MEDDEV and MDCG, serve as a valuable reference for manufacturers to understand and implement the IVDR requirements. Although not legally binding, adherence to MEDDEV is often seen as an indicator of commitment to regulatory compliance.

The Medical Device Coordination Group (MDCG), comprising representatives from all EU member states, ensures uniform application and interpretation of the new regulations across the EU. The MDCG has issued several guidance documents to aid IVDR implementation, offering practical guidance and tools.

The Medical Device Coordination Group (MDCG) has issued several guidance documents to facilitate a smooth transition to the IVDR. Here’s a summary of some of the most recent MDCG guidelines relevant to IVDs:

  • MDCG 2022-20: Guidelines on Substantial modification of performance study under the IVDR.
  • MDCG 2022-19: Guidance on Performance study application/notification documents under the IVDR.
  • MDCG 2022-15: Guidance on appropriate surveillance regarding transitional provisions under Article 110 of the IVDR.
  • MDCG 2022-10: Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and the IVDR.
  • MDCG 2022-9: Guidelines on the Summary of safety and performance template.
  • MDCG 2022-8: Guidelines on the application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022.
  • MDCG 2022-6: Guidelines on significant changes regarding transitional provision under Article 110(3) of the IVDR.
  • MDCG 2022-3: Guidelines on the Verification of manufactured class D IVDs by notified bodies.
  • MDCG 2022-2: Guidelines on general principles of clinical evidence for IVDs.
  • MDCG 2021-4: Guidelines on Application of transitional provisions for certification of class D IVDs.

The CMG Road Ahead

As we navigate this era of stringent regulatory requirements, proactive and conscientious compliance with the IVDR becomes paramount for all involved in CMG. Staying updated with the latest MEDDEV and MDCG guidance documents and understanding the implications of IVDR is crucial. Nevertheless, the collective goal remains unaltered: ensuring patient safety and maximizing the potential of Clinical Molecular Genetics in revolutionizing healthcare. Manufacturers are encouraged to regularly consult the European Commission’s website or engage with a Notified Body or a regulatory consultant for the most recent and accurate guidance.

Frequently Answers and Questions

Q: What is Clinical Molecular Genetics (CMG)?

A: Clinical Molecular Genetics (CMG) is a discipline that merges the profound understanding of molecular biology and genetics to decipher the genetic basis of a myriad of diseases. Spanning from single-gene disorders to intricate multifactorial diseases, CMG offers critical insights necessary for diagnosis and therapeutic decisions. Leveraging advancements such as next-generation sequencing (NGS) and genomics, CMG is a constantly evolving field, paving the way for a future of personalized medicine.

Q: How does the IVDR influence CMG?

A: In May 2022, the European Union implemented the IVDR (EU) 2017/746, which heralds a comprehensive regulatory framework designed to assure patient safety and the precision of diagnostic results across all EU member states. The IVDR has brought about a multitude of changes that significantly impact CMG-related IVDs, including those about manufacturing processes, distribution, and usage. The regulation places a pronounced emphasis on post-market surveillance and vigilance requirements, mandates stringent standards for quality management systems, and requires exhaustive technical documentation. Of note, genetic tests and high-throughput NGS devices are classified under Class C or D, denoting a higher risk level. This categorization calls for a comprehensive review by a Notified Body, thereby making IVDR compliance an indispensable aspect of CMG operations.

Q: Are there specific CMG MEDDEV or MDCG guidances applicable?

A: The MDCG and MEDDEV that European Commission has issued several general guidance documents to aid the transition from the In Vitro Diagnostic Directive (IVDD) to the IVDR. These documents offer invaluable insights and clarifications on the key facets of the new regulations, thus serving as crucial references for manufacturers striving to understand and implement the IVDR requirements.

Industry Insights & Regulatory Updates
ISO 10993-1:2025 From Checkbox Compliance to Risk-Based Biocompatibility

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Making IVDR Work in Combined Studies: Scientific & Operational Lessons from 40+ Programs

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ISO 14155:2026 What’s Changed and What It Means for Your Clinical Investigation

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Portugal’s New Clinical Trials Law No. 9/2026: What Sponsors Need to Know

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IMDRF Draft N91 2026: New Clinical Evidence Requirements for IVDs Explained

IMDRF Draft N91 2026: New Clinical Evidence Requirements for IVDs Explained

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

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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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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What is the Regulatory Process for IVD in Europe?

May 10, 2023

What is the regulatory process for IVD in Europe, and which are the most important aspects of it? Continue reading to learn more.

The In Vitro Diagnostic (IVD) market in Europe is regulated by a complex framework, and understanding the regulatory process for IVD is crucial for manufacturers looking to bring their products to market. With the implementation of the In Vitro Diagnostic Regulation (IVDR) in 2022, new requirements and conformity assessment routes have been introduced.

In this article, we will discuss the regulatory process for IVD in Europe, highlighting the importance of IVD consultancy and the role MDx CRO can play in developing technical documentation and managing clinical performance studies for IVDs.

1. Overview of the In Vitro Diagnostic Regulation (IVDR)

The IVDR (EU) 2017/746 came into full effect in May 2022, replacing the In Vitro Diagnostic Directive (IVDD) 98/79/EC. The regulation aims to improve patient safety and the performance of IVDs by introducing more stringent requirements for manufacturers. Some of the significant changes introduced by the IVDR include:

  • A risk-based classification system for IVD devices
  • Strengthened requirements for clinical evidence
  • Increased scrutiny of the IVD technical documentation
  • Increased post-market surveillance (PMS) requirements

2. Risk-based Classification of IVDs

The IVDR introduces a new risk-based classification system, dividing IVDs into four classes (A, B, C, and D) based on their potential risk to patients and public health. This classification system is more aligned with the global risk-based classification approach and helps determine the appropriate conformity assessment route for each IVD device.

3. Conformity Assessment Routes

Under the IVDR, manufacturers are required to follow specific conformity assessment routes based on the classification of their IVD device. The conformity assessment routes include:

  • Self-certification for Class A non-sterile devices
  • Assessment by a notified body for Class A sterile, Class B, C, and D devices

Manufacturers must choose a notified body designated under the IVDR to assess their device’s conformity. The notified body will review the technical documentation, conduct a quality management system (QMS) audit, and issue an EU Technical Documentation Assessment Report and an EU QMS Certificate, which are essential for obtaining a CE mark.

4. Technical Documentation

Technical documentation is a crucial aspect of the regulatory process for IVD in Europe. Under the IVDR, manufacturers must maintain comprehensive technical documentation that demonstrates the safety, performance, and compliance of their IVD device. The technical documentation should include:

  • Device description and specifications
  • Information about the device’s design and manufacturing process
  • Pre-clinical, analytical and clinical performance data
  • Labelling and instructions for use
  • Risk management documentation
  • QMS documentation
  • Post-market surveillance and vigilance data

5. Clinical Evidence and Performance Studies

The IVDR emphasizes the importance of clinical evidence in demonstrating the safety and performance of IVD devices. Manufacturers must conduct clinical performance studies to generate robust clinical evidence that supports their device’s intended purpose, clinical performance claims, and overall safety. The clinical evidence should be periodically updated as part of the post-market surveillance process.

6. Post-Market Surveillance (PMS)

Under the IVDR, manufacturers are required to establish a comprehensive PMS system that monitors the safety, performance, and effectiveness of their IVD device throughout its lifecycle. The PMS system should be capable of identifying and addressing potential risks, non-conformities, and adverse events.

Manufacturers must also establish a Periodic Safety Update Report (PSUR) to provide a summary of the PMS data and any necessary corrective actions.

7. The Role of IVD Consultancy and CRO

Navigating the regulatory process for IVD in Europe can be a complex and time-consuming task. Partnering with an experienced IVD consultancy can significantly streamline the process, ensuring compliance with the IVDR and facilitating a successful market entry. IVD consultancies, such as MDx CRO, offer invaluable support in various areas, including:

  • Developing technical documentation
  • Managing clinical performance studies
  • Designing and implementing a robust QMS
  • Guiding through the risk management process
  • Assisting with post-market surveillance and vigilance activities

8. How MDx CRO Can Help

MDx CRO is a leading IVD consultancy and IVD CRO that specializes in helping manufacturers navigate the regulatory process for IVD in Europe. Our team of experts has extensive experience in developing technical documentation and managing clinical performance studies for IVDs, ensuring compliance with the IVDR.

We offer the following services:

  • Technical documentation development: Our team will work closely with you to create comprehensive technical documentation that demonstrates your IVD device’s safety, performance, and compliance with the IVDR.
  • Clinical performance study management: We design and manage clinical performance studies tailored to your IVD device, generating robust clinical evidence that supports your device’s intended purpose and clinical performance claims.
  • Post-market surveillance support: We assist manufacturers in establishing a comprehensive PMS system, ensuring continuous monitoring of the safety and performance of your IVD device throughout its lifecycle.

Regulatory Process for IVD: Conclusion

Understanding the regulatory process for IVD in Europe is crucial for manufacturers looking to bring their products to market successfully. The IVDR has introduced new requirements and conformity assessment routes that manufacturers must comply with to ensure patient safety and the performance of their IVD devices.

Partnering with an experienced IVD consultancy like MDx CRO can significantly streamline the process, providing invaluable support in developing technical documentation, managing clinical performance studies, and ensuring compliance with the IVDR.

Are you in need of expert guidance and support to navigate the regulatory process for IVD in Europe? Contact MDx CRO today to learn more about our IVD consultancy services and how we can help you successfully bring your IVD device to market.

FAQs

What are the key changes introduced by the In Vitro Diagnostic Regulation (IVDR) in Europe?

The IVDR has introduced several significant changes to the regulatory process for IVD in Europe. Some of the key changes include:

  • A new risk-based classification system for IVD devices, dividing them into four classes (A, B, C, and D) based on their potential risk to patients and public health.
  • More stringent requirements for clinical evidence, emphasizing the importance of conducting clinical performance studies to generate robust clinical data.
  • Increased scrutiny of the IVD technical documentation to ensure the safety, performance, and compliance of IVD devices.
  • Enhanced post-market surveillance (PMS) requirements, mandating manufacturers to establish a comprehensive PMS system that monitors the safety and performance of their IVD devices throughout their lifecycle.

How can an IVD consultancy like MDx CRO help manufacturers navigate the regulatory process for IVD in Europe?

MDx CRO, a leading IVD consultancy, offers expert guidance and support to help manufacturers navigate the complex regulatory process for IVD in Europe. Our services include:

  • Developing technical documentation that demonstrates the safety, performance, and compliance of IVD devices according to the IVDR requirements.
  • Designing and managing clinical performance studies tailored to the specific IVD device, generating robust clinical evidence to support its intended purpose and clinical performance claims.
  • Assisting with the establishment of a comprehensive post-market surveillance system, ensuring continuous monitoring and addressing any potential risks, non-conformities, or adverse events throughout the device’s lifecycle.

By partnering with MDx CRO, manufacturers can ensure compliance with the IVDR and successfully bring their IVD devices to the European market.

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IVDR Compliance Made Easy: The Importance of an IVDR Pre-Submission Assessment

May 3, 2023

What are the most important things you’ll need to know when it comes to IVDR pre-submission assessment? 

The In Vitro Diagnostic Regulation (IVDR) is a new regulation that took effect on May 26, 2022, replacing the In Vitro Diagnostic Directive (IVDD) and introducing new requirements for manufacturers of in vitro diagnostic medical devices (IVDs). A major change is the increased scrutiny of technical documentation by Notified Bodies (NBs).

To prevent time-consuming and costly NB processes and avoid product rejections, manufacturers can undertake an IVDR Pre-Submission Technical Documentation Assessment with a specialised IVD consultancy like MDx CRO. This assessment comprises a completeness check, consistency check, full review, and comprehensive report.

Why is an IVDR Pre-Submission Technical Documentation Assessment crucial?

An IVDR Pre-Submission Technical Documentation Assessment is a valuable tool for manufacturers striving to comply with the new IVDR requirements. Identifying gaps in technical documentation and offering recommendations for enhancement, this assessment helps manufacturers achieve IVDR compliance, thus ensuring a predictable go-to-market strategy.

Moreover, a pre-submission documentation review prepares manufacturers for the actual Notified Body (NB) review process, enabling them to pinpoint areas needing improvement in their technical documentation and ensuring full preparedness for the NB review.

What does an IVDR Pre-Submission Technical Documentation Assessment entail? 

The review process starts with a completeness check phase. The completeness check verifies the submitted technical documentation is complete, searchable, ensuring all required documents are present and that they meet, on a high level, the requirements of the IVDR as per the specific Notified Body best practice guidance. The output is a completeness check form verified by MDx CRO and a 1st milestone meeting & presentation. 

The assessment proceeds to a full technical documentation review, which involves reviewing all technical documentation submitted by the manufacturer as if it was an actual Notified Body assessment, using our unique knowledge of Notified Body expectations and assessment skills and technique.

This includes checking that all documents meet the requirements of the IVDR and that they are consistent with each other. The output is a comprehensive report and strategic presentation to the client. The full report includes a summary of identified gaps and tracing them to the corresponding IVDR requirements.

It also includes a high-level quality plan with an outline of recommendations to achieve IVDR compliance. The solutions range from providing justifications for nonapplicable requirements to providing recommendations for documentation updates, remedial product testing, or closing clinical evidence gaps.

The final step involves conducting a consistency check, to verify the coherence of the technical documentation. This includes checking that all documents are consistent with each other and that there are no contradictions or errors, including in the intended purpose, product descriptions, codes applied, benefits and risks, among others.

Inconsistency of technical documentation is one of the top findings of Notified Bodies and with limited opportunities for product approval, this is an area manufacturers should be particularly vigilant about.  The output of MDx assessment is a redline through the technical documentation for consistency, which will serve as a remediation plan. 

What is included in our Full Technical Documentation Review?

Our assessment of IVD technical documentation includes a comprehensive evaluation of all aspects of the documentation, following a similar process of the Notified Body (NB), in compliance with Annex II and Annex III of the EU IVDR 2017/746.

Our analysis involves a comprehensive examination of the documentation’s depth, taking into account various factors such as risk classification, suitability of product claims, intended use, and current industry standards.

Moreover, we assess the device’s compliance with regulatory requirements and its traceability, from labelling to design inputs, manufacturing, design outputs, verification, validation, and post-market surveillance (PMS).

Our assessment includes a thorough evaluation of clinical evidence data and the performance evaluation process, ensuring the device’s benefit/risk acceptability is appropriate. Furthermore, we include an evaluation of post-market surveillance (PMS), including the Post-Market Performance Follow-up (PMPF), to identify any potential issues that may arise with the device’s use and ensure its continued safety and effectiveness.

In summary, our assessment covers all aspects of technical documentation review to ensure that the medical device is safe and effective for its intended use, meeting all regulatory requirements.

In addition, we provide customized solutions to our clients. One area that manufacturers often seek our expertise is in clinical evidence, which is a popular area for them to validate. As noted by Carlos Galamba, MDx CRO’s Founder and former BSI Internal Clinician, “Clinical performance alone accounts for 40% of all notified body findings”

Detailed Scope​:

Our pre-submission technical documentation review can cover some or all of the following areas:

  • Device description, intended purpose, classification review and product claims​
  • Declaration of conformity ​
    • Regulatory requirements, review of strategy for DoCs covering multi-products​
  • Information supplied by the manufacturer, ​
    • Regulatory review of labels and IFUs for compliance with regulatory and harmonized standards​
    • Review of specific requirements for self-tests and near patient tests.​
  • Design and manufacturing information​
    • Design specifications, determination of critical ingredients, Notified Body methods for assessment of hazardous substances (CLP and REACH compliance), ​
    • Manufacturing processes, appropriateness of quality control testing and specifications​
    • Specific design aspects for self-testing & near-patient testing devices​
  • General Safety and Performance Requirements (GSPRs)
    • Review process, applicability and methods used for compliance. ​
  • Electrical safety and Electromagnetic compatibility where applicable​
  • Software verification & validation where applicable
  • Full Risk management review: ​
    • Plans, procedures, reports. ​
    • Review of technology-based risks in the areas of design, production and user/product risks.​
  • Product verification and validation: ​
    • Specimen: claims, sample types, storage handling and transport conditions​
    • Stability: packaging validation, in-use stability, transport stability, shelf-life and specimen stability.​
  • Full performance evaluation and clinical evidence assessment: ​
    • Performance Evaluation Plan (PEP), Scientific Validity Report (SVR), Analytical Performance Report (APR), Clinical Performance Study Plans and Reports (CPSP and CPSR), Clinical Performance Report (CPR), Performance Evaluation Report (PER), usability study protocols and reports, Summary of Safety and Performance (SSP). Includes a review of the appropriateness of the performance strategy based on claims and patient populations. ​
  • Standards and guidelines​
    • Assessment of the device against EU Common Technical Specifications, technical state of the art guidance (e.g. CLSI guidelines, WHO), harmonized standards and regulatory requirements ​
  • Post Market Surveillance: ​
    • Review of complaints data, trend analysis and vigilance. Adequacy of PMS and PMPF plans for product type. Evaluation of the outputs of PMPF, PMS reports and PSURs.

What are the benefits of undergoing an IVDR Pre-Submission Technical Documentation Assessment?

Undergoing an IVDR Pre-Submission Assessment can provide several benefits for manufacturers. These include:

  • Avoiding costly Notified Body (NB) processes and product rejections: By identifying gaps in technical documentation early on, manufacturers can avoid lengthy and costly NB processes and product rejections.
  • Reducing time to market: By identifying areas where they need to improve their technical documentation early on in the development process, manufacturers can avoid costly delays later on.
  • Ensuring compliance with IVDR requirements: The IVDR introduces new requirements for clinical evidence, performance evaluation, and risk management. By undergoing an IVDR Pre-Submission Technical Documentation Assessment, manufacturers can ensure that their documentation meets all requirements and is fully prepared for NB review.
  • Improving product safety and effectiveness: By identifying gaps in technical documentation and providing recommendations for improvement, manufacturers can ensure the safety and effectiveness of their products.

How can MDx CRO help with an IVDR Pre-Submission Technical Documentation Assessment? 

MDx CRO is a regulatory consulting firm that specializes in helping medical device & IVD manufacturers comply with regulatory requirements. We offer a range of services to help manufacturers prepare for the new IVDR requirements, including pre-submission technical assessments and remediation solutions.

Our team of experts has extensive experience in scientific validity reports for EU IVDR submission, regulatory affairs, quality assurance, clinical research, and medical writing. We work closely with our clients to identify gaps in their technical documentation and provide recommendations for improvement.

By working with MDx CRO, manufacturers can ensure that their technical documentation meets all IVDR requirements and is fully prepared for NB review. Our services can help manufacturers avoid costly delays and product rejections while ensuring the safety and effectiveness of their products.

This proactive approach not only saves time and resources but also ensures the continued success of IVD manufacturers in the ever-evolving regulatory landscape.

FAQ

What is IVDR and why does it matter for IVD manufacturers?

The In Vitro Diagnostic Regulation (IVDR – EU 2017/746) replaced the previous IVDD framework. It also introduced stricter requirements for clinical evidence, performance evaluation, risk management, and technical documentation. One of the most significant changes is the increased scrutiny by Notified Bodies (NBs), meaning manufacturers must present more robust, structured, and consistent technical files to achieve certification.

What is an IVDR Pre-Submission Technical Documentation Assessment?

An IVDR Pre-Submission Technical Documentation Assessment is a structured review of your technical documentation before submission to a Notified Body.
It simulates the NB assessment process and helps identify:
Gaps in documentation
Missing or inconsistent data
Weak clinical evidence
Risk management deficiencies
Non-compliance with IVDR requirements
The goal is to ensure your documentation is complete, consistent, and submission-ready.

Why is a pre-submission assessment important?

Under IVDR, NB capacity is limited and rejection risks are high. A pre-submission review helps you:
Avoid costly and time-consuming NB findings
Reduce the risk of product rejection
Shorten time to market
Strengthen your regulatory strategy
Ensure predictable approval timelines
Early gap identification prevents major remediation efforts later.

What are the main phases of the assessment process?

The process typically includes three key stages:
1. Completeness Check
2. Full Technical Documentation Review
3. Consistency Check

What is included in a Full Technical Documentation Review?

A comprehensive review covers:
-Device description and intended purpose
-Risk classification and product claims
-Declaration of Conformity
-Labeling and IFU regulatory compliance
-Design and manufacturing information
-General Safety and Performance Requirements (GSPRs)
-Risk management files
-Verification and validation data
-Stability studies and specimen handling
-Software validation (if applicable)
-Electrical safety and EMC (if applicable)
-Performance evaluation and clinical evidence
-Post-Market Surveillance (PMS) and PMPF
-Compliance with harmonized standards and EU Common Technical Specifications
-Special attention is typically given to clinical evidence and performance evaluation, as these are frequent areas of NB findings.

Why is clinical evidence such a critical focus area?

Under IVDR, performance evaluation requirements are significantly expanded.
Clinical performance, scientific validity, and analytical performance must be clearly demonstrated and aligned with product claims and intended use.
Weak or incomplete clinical evidence is one of the most common causes of NB findings, making early review essential.

What common issues does a pre-submission review uncover?

Frequent findings include:
Inconsistent intended purpose statements
Unsupported product claims
Gaps in clinical performance data
Incomplete risk management documentation
Misalignment between labeling and technical files
Missing traceability between design inputs and validation outputs
Weak PMS or PMPF planning
These issues can delay certification if not addressed early.

How does this assessment reduce time to market?

By identifying documentation gaps before NB submission, manufacturers can:
Avoid iterative rounds of NB questions
Reduce major non-conformities
Prepare structured responses in advance
Align internal teams around a remediation plan
This proactive preparation significantly shortens the approval cycle.

Who should consider an IVDR Pre-Submission Assessment?

This assessment is especially valuable for:
Manufacturers transitioning from IVDD to IVDR
Class C and Class D device manufacturers
Companies with limited internal IVDR expertise
Organizations with new clinical evidence requirements
Manufacturers planning first-time NB submission

How can MDx CRO support IVDR compliance?

MDx CRO provides structured pre-submission technical documentation reviews and tailored remediation strategies.
Support includes:
Full IVDR Annex II & III documentation review
Clinical evidence validation
Performance evaluation gap analysis
Risk management alignment
PMS and PMPF strategy review
Regulatory strategy consulting
By working with experienced regulatory and clinical experts, manufacturers can strengthen submission readiness and reduce approval uncertainty.

What are the overall benefits of undergoing this assessment?

An IVDR Pre-Submission Assessment helps manufacturers:
Minimize regulatory risk
Improve documentation quality
Strengthen clinical justification
Enhance product safety and effectiveness
Avoid costly rework
Achieve more predictable regulatory outcomes

Written by:
Carlos Galamba

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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EU Q&A Guide: Amendments to MDR and IVDR Transitional Provisions

March 27, 2023

In our latest article, MDx offers a comprehensive summary of the European Commission’s Q&A document, focusing on the implementation of Regulation (EU) 2023/607, which amends transitional provisions for specific medical devices and in vitro diagnostic devices under Regulations (EU) 2017/745 and (EU) 2017/746.

The EU Q&A document provides further clarity to the MDR/IVDR amendment, which aims to maintain public health protection, patient safety, prevent medical device shortages, and preserve existing quality and safety standards.

This amending regulation extends the timeline for manufacturers and notified bodies to complete conformity assessments in line with the MDR and removes the ‘sell-off’ date in the MDR and IVDR to prevent unnecessary disposal of safe devices. The document’s responses consider the amendment’s objectives and seek to optimize the extended MDR transitional period.

Part A – Scope of the extension of the MDR transitional period

Which devices can benefit from the extended transitional period?

  • Only ‘legacy devices’ can benefit from the extended transitional period, which includes class I devices under Directive 93/42/EEC (MDD) and devices covered by a valid EC certificate issued in accordance with Directive 90/385/EEC (AIMDD) or the MDD prior to 26 May 2021.

Can devices that have already been certified in accordance with the MDR benefit from extended transitional period?

  • Yes, provided their MDD/AIMDD certificates have not been withdrawn by the notified body. ‘Legacy devices’ and corresponding MDR compliant devices can be placed on the market in parallel until the end of the relevant transitional period.

What about ‘legacy devices’ for which the manufacturer does not wish to apply under the MDR?

  • Manufacturers are not obliged to apply for their ‘legacy devices’ under the MDR. If they do not lodge an application for conformity assessment by 26 May 2024, the transitional period will end on that date.

Which classification rules apply to determine whether the extended transitional period ends on 31 December 2027 or on 31 December 2028?

  • The classification rules laid down in Annex VIII to the MDR apply to determine the end date of the transitional period based on the device’s risk class.

Does the extended transitional period also apply to custom-made devices?

  • A specific transitional period for class III custom-made implantable devices has been introduced by the new Article 120(3f) MDR, allowing them to be placed on the market without the relevant certificate until 26 May 2026, provided certain conditions are met.

If a certificate has expired before 20 March 2023 and a competent authority has granted a derogation in accordance with Article 59 MDR or has applied Article 97 MDR, how long is the transitional period?

  • The device benefits from the full transitional period until 31 December 2027 or 31 December 2028, as applicable, provided the conditions set out in Article 120(3c) MDR are fulfilled. The certificate is deemed to be valid until the end of the applicable transitional period, unless it is withdrawn.

Part B – Evidence of extended transitional period

How can the manufacturer demonstrate that its legacy device benefits from the extension of the transitional period?

  • The EU Q&A document clarifies that the amendments to MDR/IVDR and the extension to the transitional period and the certificate’s validity is automatic by law, provided certain conditions are met. Manufacturers can demonstrate the validity of the certificate to third parties through different means, including:
  • A self-declaration confirming that the conditions for the extension are fulfilled and stating the end date of the transition period, which could be based on a harmonized template.
  • A ‘confirmation letter’ issued by the notified body stating the receipt of the manufacturer’s application for conformity assessment and the conclusion of a written agreement. The confirmation should clearly identify the devices and certificates covered by the extension and could be based on a harmonized template issued without extra costs.
  • Competent authorities can issue certificates of free sale for the duration of the extended certificate validity.
  • The European Commission will update its factsheets to explain the functioning of the extended transition period for competent authorities in non-EU/EEA countries, healthcare professionals, healthcare institutions, and the procurement ecosystem.

Part C – Conditions to be fulfilled to benefit from the extended MDR transition period

What are the necessary elements of a formal application lodged by the manufacturer?

  • The application should include the elements listed in the relevant conformity assessment as referred to in Annexes IX to XI to the MDR, excluding documentation not needed for the conclusion of the written agreement. The application must clearly identify the manufacturer and the devices covered by the application. The manufacturer should provide a timeline for possible submission of the individual technical documentation and any other relevant information.

What are the necessary elements of a written agreement between the manufacturer and the notified body?

  • The written agreement should be based on the formal application lodged by the manufacturer and include a schedule for the submission of relevant documentation, such as the full technical documentation for all devices covered by the application.

What is the meaning of “device intended to substitute that device”?

  • A device intended to substitute the legacy device will usually differ from the legacy device due to significant changes in its design or intended purpose. The manufacturer is responsible for determining the substitute device and explaining the link to the substituted legacy device.

Which evidence does the manufacturer have to provide for having put in place a QMS in accordance with the MDR?

  • Manufacturers must draw up the documentation on its QMS, which needs to be part of the application for conformity assessment

Do manufacturers, which have lodged an application for conformity assessment and have concluded a written agreement with a notified body before 20 March 2023, have to lodge a new application and/or conclude a new written agreement?

  • No. Applications lodged prior to the entry into force of the amending Regulation 2023/607 (i.e., 20 March 2023) remain valid and are sufficient for fulfilling the condition set out in Article 120(3c), point (e) MDR. No new written agreement needs to be signed either.

Part D – Appropriate surveillance to be performed by notified bodies

What are the necessary elements of the arrangement for the transfer of the surveillance from the notified body that issued the MDD/AIMDD certificate to the MDR notified body?

  • The arrangement should follow the same principles outlined in Article 58(1) MDR, including the transfer of relevant documentation and addressing the possibility of the MDR notified body to suspend or withdraw a certificate issued by the MDD/AIMDD notified body, where duly justified.

What does the limitation ‘where practicable’ imply?

  • It takes into account cases where the notified body that issued the relevant certificate under the MDD/AIMDD might be unable to sign the contract, e.g., due to termination of business. A written agreement between the manufacturer and the MDR notified body is still required.

Which notified body is responsible for carrying out the appropriate surveillance when a written agreement in accordance with Article 120(3c), point e, MDR is signed between the manufacturer and a notified body designated under the MDR?

  • The notified body that issued the relevant certificate under the MDD/AIMDD continues to be responsible for the appropriate surveillance until 26 September 2024, after which the notified body that signed the agreement will become responsible for the appropriate surveillance.

In case there is an arrangement for the transfer of the surveillance to a different notified body designated under MDR, what are the implications on the labeling concerning the notified body’s identification number?

  • Legacy devices can continue to be placed on the market and made available without changes to the labeling, including CE marking, indicating the number of the notified body that issued the certificate under the Directive. However, the manufacturer may decide to modify the labeling of legacy devices indicating the number of the notified body to which a formal application under the MDR has been lodged, if practically feasible.

Is the NB, which issued the certificate in accordance with Article 120(3b) of MDR, legally obliged to continue to carry out the surveillance of the products concerned until the end of the new transitional period or until the manufacturer has transferred this surveillance obligation to an MDR NB? May this NB deny the manufacturer the use of its NB number?

  • The previous notified body must continue the surveillance until 26 September 2024 at the latest. Unless otherwise specified in the tripartite agreement, the use of the number of the notified body that issued the certificate must not be denied until the end of the transition period.

Part E – Deletion of the ‘sell-off’ date

Which devices will benefit from the removal of the ‘sell-off’ date?

  • Medical devices that have been placed on the market prior to 26 May 2021 in accordance with the MDD/AIMDD or after 26 May 2021 during the transitional period provided for in Article 120 MDR (i.e. until 31 December 2027 or 31 December 2028, as applicable) will benefit from the removal of the ‘sell-off’ date. They may continue to be made available on the market or put into service without any limitation in time without prejudice to the device’s possible shelf-life or expiry date.
  • Similarly, in vitro diagnostic medical devices that have been placed on the market prior to 26 May 2022 in accordance with the IVDD or after 26 May 2022 during the transitional period provided for in Article 110 IVDR (i.e. until 26 May 2025, 26 May 2026 or 26 May 2027, as applicable) will also benefit from the removal of the ‘sell-off’ date. These IVD devices may continue to be made available on the market or put into service without any limitation in time without prejudice to the device’s possible shelf-life or expiry date.

Please note this article is intended as a summary, to access the full Q&A document, please consult the original source provided by the commission.

How can MDx help?

MDx CRO is a leading quality, regulatory and contract research (CRO) consulting company dedicated to the medical device and diagnostic sectors.

MDx can help medical device & IVD manufacturers navigate the new requirements introduced by the amendment to the MDR and IVDR legislation through Regulation (EU) 2023/607. Our team of experts can provide comprehensive guidance and support to ensure your company’s compliance with the extended transitional period, updated classification rules, and other relevant aspects of the legislation.

We can assist with the following key areas:

  • Determining the eligibility of your devices to benefit from the extended transitional period.
  • Preparing and submitting formal applications for conformity assessment in accordance with the MDR, including the necessary elements for a written agreement with the notified body.
  • Assisting with the transfer of surveillance from the notified body that issued the MDD/AIMDD certificate to the MDR notified body, ensuring a smooth transition and continuous market access for your devices.
  • Helping manufacturers identify substitute devices and ensure compliance with the amended regulations.
  • Providing support for the implementation of a Quality Management System (QMS) in accordance with the MDR, including the preparation of relevant documentation.

Our experienced team at MDx is well-equipped to help you understand and meet the new requirements introduced by this amendment to the MDR and IVDR legislation, ensuring that your medical devices remain compliant and can continue to be placed on the market without disruption.

Contact us today for a consultation with our medical device experts.

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