Understanding MDCG 2021-6 Rev. 1: A Comprehensive Guide for Clinical Investigations under EU MDR

Written by Alberto Bardaji de Qixano Published on 16.03.2024 Last updated on 16.06.2026

March 16, 2024

The Medical Device Regulation (MDR) 2017/745 has transformed the EU’s regulatory landscape for medical devices. It aims to boost patient safety and transparency. The regulation sets strict criteria for clinical investigations. In this context, MDCG 2021-6 Rev. 1 is key. Issued by the Medical Device Coordination Group (MDCG), it underwent a revision in December 2023.

This update offers valuable insights. It addresses common questions about clinical investigations under MDR. The impact is wide-reaching. Manufacturers, sponsors, competent authorities, research centers, ethics committees, legal representatives, and CROs are all affected. This guide explores MDCG 2021-6 Rev. 1’s vital aspects. Moreover, it highlights its implications for these stakeholders.

Introduction to MDCG 2021-6 Rev. 1

MDCG 2021-6 Rev.1 is a cornerstone document for those embarking on clinical investigations of devices within the scope of the Medical Device Regulation (EU) 2017/745 (MDR). Designed for sponsors, this evolving guide may expand with more questions and answers over time. It clarifies the use of the term ‘device’ in line with MDR. This includes medical devices, their accessories, and specific products listed in Annex XVI.

The guide also standardizes the definition of “clinical investigation.” It aligns with Article 2(45) of the MDR, focusing on investigations aimed at assessing a device’s safety or performance. Moreover, it introduces the broader concept of “clinical study.” This encompasses a range of research activities within medical science. It includes clinical trials of medicines, device investigations, and in vitro diagnostic studies. These elements are vital for understanding the full scope of clinical research.

This document touches on key topics crucial for navigating the regulatory landscape:

Proof of Concept Studies: Offering insights into the initial stages of device development.
Article 82 Clinical Studies: Clarifying the scope of broader research activities under MDR.
Pilot Stage Investigations: Defining early feasibility and its regulatory implications.
Regulatory Pathways: Shedding light on navigating clinical investigations amidst the interplay of MDR, the Clinical Trial Regulation (CTR), and local laws.
Combined Trials: Addressing the complexities of studies involving both medicinal products and medical devices.
Invasive or Burdensome Considerations: Guiding sponsors on ethical and participant safety considerations.
Usability Testing: Outlining when such tests are considered clinical investigations.
Retrospective Testing: Distinguishing between prospective data collection and the analysis of existing data.
Submissions and Modifications: Offering guidance on navigating regulatory submissions and changes during the clinical investigation process.
Legal Representation: Emphasizing the role of legal representatives in ensuring compliance.

Some of the Key Highlights of MDCG 2021-6 Rev. 1

MDCG 2021-6 Rev. 1 offers an in-depth exploration into the clinical investigations aspects under the Medical Device Regulation (EU) 2017/745 (MDR). This document is instrumental in bridging the regulatory gaps and ensuring a harmonized approach across the European Union. Here are the refined key highlights based on the updated request:

Regulatory Pathways and Documentation

The document elaborates on navigating the regulatory landscape for conducting clinical investigations. It includes guidance on choosing the correct regulatory pathway, be it for a novel device entering early-stage clinical investigation or for further assessment of a CE-marked device. Detailed documentation requirements facilitate sponsors in preparing comprehensive applications, streamlining the approval process.

Legal Representative’s Role and Responsibilities

The document provides clarity on the responsibilities of the sponsor’s legal representative, which is pivotal for non-EU manufacturers. It underlines the need for a legal representative within the EU to ensure compliance with MDR requirements. This representative acts as a point of contact between the non-EU sponsor and the EU regulatory authorities, facilitating the submission and communication processes.

Substantial Modifications

Understanding what constitutes a substantial modification is crucial for the continuity and compliance of clinical investigations. MDCG 2021-6 Rev. 1 details the criteria for identifying substantial modifications that could impact the safety, health, or rights of subjects, or the reliability and robustness of the clinical data.

This guidance aids sponsors in navigating the process for notifying competent authorities about such modifications, ensuring that the integrity and validity of the investigation are maintained.

Relationship with the CTR, Combined Trials, and Combination Products

The document delves into the interplay between medical device regulations and the Clinical Trials Regulation (CTR), particularly in the context of combined trials and combination products. It highlights the importance of navigating both regulatory frameworks when a study involves medical devices and medicinal products. This includes guidance on conducting clinical studies that collect data for both devices and associated medicinal products, ensuring compliance with the MDR and CTR. The document’s insights into handling combination products—where devices and medicinal substances are integrated—are crucial for sponsors planning such studies.

Clarifications on Specific Aspects of Clinical Investigations

MDCG 2021-6 Rev. 1 sheds light on several nuanced areas of clinical investigations:

Usability Testing: It clarifies when usability tests are considered clinical investigations.
Invasiveness Considerations: The document defines what constitutes invasive procedures and the implications for clinical investigations, emphasizing the importance of assessing the invasiveness level when planning studies.
Retrospective Studies: Insights are provided on the role of retrospective studies within clinical investigations, delineating when such studies fall under the scope of clinical investigation definitions and how they contribute to clinical evaluations.
Proof of Concept Studies: Guidance on conducting proof of concept studies is highlighted, including their significance in the early stages of device development and their regulatory considerations under the MDR.

In-Depth Highlights of MDCG 2021-6 Rev. 1 for Specialized Clinical Investigations

Proof of Concept Studies according MDCG 2021-6 Rev. 1

Proof of Concept (PoC) studies are instrumental in the nascent phases of medical device development. These studies aim to demonstrate the feasibility and potential clinical benefits of a device, laying the groundwork for subsequent development stages. MDCG 2021-6 Rev. 1 provides comprehensive guidance on PoC studies, emphasizing their critical role in validating device concepts and navigating the regulatory framework of the MDR.

PoC studies serve as a foundational element in device development, enabling sponsors to assess a device’s early clinical viability and address potential design modifications before advancing to more comprehensive clinical trials. The guidance from MDCG 2021-6 Rev. 1 ensures that these studies are conducted within a framework that prioritizes patient safety, scientific validity, and regulatory compliance.

By focusing on detailed planning, ethical conduct, and adherence to specified regulatory pathways, PoC studies under the guidance of MDCG 2021-6 Rev. 1 facilitate a smoother transition through the early stages of device development.

MDCG 2021-6 Rev. 1 delineates the regulatory pathways essential for conducting PoC studies that support the conformity assessment of the device under investigation. It specifies the need for a meticulously detailed Clinical Investigation Plan (CIP), ensuring that PoC studies are grounded in solid scientific rationale and ethical considerations. This guidance is particularly highlighted in:

Question 7, which discusses the regulatory pathways for clinical investigations aimed at supporting device conformity assessments.
Question 11, focusing on the investigational use of CE-marked devices for new potential applications or further PoC studies.
Question 8, which identifies clinical investigations considered at the pilot stage, setting the stage for PoC studies.
Question 9, providing a roadmap for conducting early feasibility and first-in-human studies under the MDR, underscoring the importance of thorough risk assessment and ethical considerations.

Combined Trials

Combined Trials represent a pivotal area of focus within the regulatory landscape of clinical investigations, particularly when these involve both medical devices and medicinal products.

The MDCG 2021-6 Rev. 1 and MDCG 2022-10 documents offer a comprehensive overview of the complexities and regulatory pathways for conducting such trials, highlighting the necessity for compliance with the Medical Device Regulation (EU 2017/745, MDR) and the Clinical Trials Regulation (EU 536/2014, CTR), as well as with the In Vitro Diagnostic Regulation (EU 2017/746, IVDR).

Questions 15 and 16 in MDCG 2021-6 Rev. 1 and the detailed guidance in MDCG 2022-10 illuminate the pathway for combined trials involving medical devices and medicinal products. This guidance is crucial for sponsors planning studies that bridge the gap between medical devices and pharmaceuticals, offering clear directives on navigating combined trials.
The concept of “combined trial” is further elaborated to include simultaneous investigation of a medicinal product (clinical trial authorized under the CTR) and an IVD (clinical performance study), subject to the requirements of both the CTR and IVDR.
Sponsors are encouraged to thoroughly understand and comply with both MDR/IVDR and CTR requirements, ensuring that all aspects of the combined trials are adequately addressed.

Usability Studies

Usability studies are paramount in ensuring that medical devices meet the highest standards of safety and performance through effective user interface design. The MDCG 2021-6 Rev. 1 document, alongside the EN 62366-1:2015 standard, provides comprehensive guidance on when and how usability studies are considered within the scope of clinical investigations under the MDR.

It emphasizes the crucial role of usability studies in integrating user feedback into the device design and development processes. This aligns with the focus of EN 62366-1:2015 on user interface characteristics that foster both safety and user satisfaction, highlighting the importance of these studies in enhancing device usability and overall patient care.

Usability testing evaluates how well users can interact with a device within specified environments, aiming to enhance the user interface to promote performance, safe, and satisfying use.

Question 17 of MDCG 2021-6 Rev. 1 clarifies when usability studies are regarded as clinical investigations under the MDR. The classification hinges on the study’s scope, purpose, and the extent to which users are exposed to the device.
Usability testing that exposes users to device-related risks or where poor usability could impact patient or user safety is more likely to fall under the definition of a clinical investigation. Manufacturers must document their rationale for classifying a usability test as outside the scope of a clinical investigation when human subjects are involved.
Manufacturers should strategically design usability tests to limit human exposure to risks before investigating device performance and safety in clinical investigations.
Documentation of usability considerations, as part of the technical documentation, is critical. This includes justifying why certain usability tests do not constitute clinical investigations, ensuring compliance with both MDCG 2021-6 Rev. 1 guidance and EN 62366-1:2015 requirements.

Invasive or Burdensome Considerations in MDCG 2021-6 Rev. 1

Question 13 is particularly relevant for ensuring the ethical conduct and safety of participants in clinical investigations. It delves into what is considered burdensome or invasive, guiding sponsors in designing studies that minimize discomfort or risk to participants. This question is vital for maintaining ethical standards and participant welfare in both medical device and in vitro diagnostic studies under IVDR.

Impact on Medical Device Stakeholders

The MDCG 2021-6 Rev. 1 document significantly influences the medical device sector. It offers pivotal guidance that extends well beyond the regulatory framework to affect various stakeholders involved in the lifecycle of a medical device within the European Union.

Manufacturers and Sponsors

Manufacturers and sponsors find in MDCG 2021-6 Rev. 1 an essential roadmap. This guidance provides clarity on regulatory requirements, helping to streamline clinical investigations, mitigate risks, and shorten the time-to-market for innovative solutions.

Strategic Planning and Execution: The document outlines regulatory pathways for different types of clinical investigations, facilitating better planning and execution.
Risk Management: Emphasizes the importance of safety reporting and ethical considerations, aiding in the development of comprehensive risk management strategies.

Competent Authorities and Ethics Committees

Competent authorities and ethics committees are crucial in the regulatory oversight of medical devices. MDCG 2021-6 Rev. 1 enhances their ability to assess and ensure compliance with the MDR, promoting a unified application across the EU.

Streamlined Review Processes: Provides clear guidelines that support more efficient review and approval processes, contributing to quicker decision-making.
Enhanced Transparency and Consistency: Promotes transparency and consistency in the review of clinical investigations, bolstering the collaborative effort across Member States.

Research Centers and CROs

Research centers and Contract Research Organizations (CROs) play a vital role in conducting clinical investigations. The document offers them detailed guidance on designing and implementing studies that align with regulatory expectations and scientific rigor.

Design and Conduct of Studies: Facilitates the incorporation of ethical considerations and safety reporting in study designs, ensuring the generation of reliable and meaningful data.
Collaboration Enhancement: Aids in fostering collaborations between industry and research entities, ensuring that studies are conducted efficiently and effectively.

Legal Representatives

Legal representatives are instrumental in ensuring that the sponsor’s obligations under the MDR are met, particularly for non-EU sponsors. MDCG 2021-6 Rev. 1 clarifies their roles and responsibilities, ensuring compliance across the board.

Regulatory Compliance: Guides legal representatives in navigating the MDR requirements, ensuring sponsors fulfill their regulatory duties.

Patients and the General Public

The ultimate beneficiaries of the MDCG 2021-6 Rev. 1 are patients, who gain access to safer and more performance-oriented medical devices.

Access to Innovative Treatments: Enhances patient access to new and innovative medical devices, improving treatment options and patient care.
Enhanced Patient Safety: Prioritizes patient safety through rigorous clinical investigation standards.

Conclusion

The MDCG 2021-6 Rev. 1 marks a significant stride in the EU’s approach to medical device regulation. This document is vital for navigating the complexities of the Medical Device Regulation (EU 2017/745, MDR). It offers a roadmap that impacts a wide range of stakeholders, from manufacturers to regulators and researchers.

Guidance and Collaboration MDCG 2021-6 Rev. 1 details the path for clinical investigations under MDR. It covers regulatory pathways, changes in trials, and usability considerations. This guidance is crucial. It ensures that devices entering the market are both innovative and safe. The document encourages collaboration across the sector, highlighting the shared goal of enhancing patient care.
Impact Across the Board Manufacturers, competent authorities, ethics committees, and others find value in this guidance. It clarifies MDR compliance, aiding in the efficient development and evaluation of medical devices. The emphasis is on using feedback, ensuring ethical conduct, and strategic planning. This collaborative effort advances medical device safety and innovation.
Benefiting Patients and the Public Ultimately, patients and the public stand to gain the most. They benefit from safer, more performance-oriented medical devices. The document fosters an environment where patient care is at the forefront. Innovations in device technology directly enhance patient outcomes and treatment options.
Moving Forward As the regulatory landscape evolves, staying informed and adaptable is key. Stakeholders must use MDCG 2021-6 Rev. 1 insights to meet the MDR’s demands. This commitment to high standards in device development and evaluation will continue to benefit European healthcare.

Written by:

Alberto Bardaji de Qixano

Master of Engineering with close to 20 years of international experience in product development, regulatory affairs and market access of Medical Devices. Authorized MDR and ISO 13485 QMS Auditor.

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Why Choose an ISO 14155-Compliant MedTech CRO under MDR?

Written by Carlos Galamba Published on 03.12.2023 Last updated on 16.03.2026

December 3, 2023

In the challenging field of medical device development, particularly under the EU Medical Device Regulation (MDR), selecting the right Contract Research Organization (CRO) is pivotal. A crucial aspect often overlooked is the CRO’s adherence to ISO 14155, the international standard for good clinical practice in clinical trials, which becomes even more significant in light of the MDR’s stringent requirements.

Selecting an ISO 14155-compliant MedTech CRO under EU MDR ensures enhanced data reliability and patient safety. This compliance is key to successful clinical trials, aligning with MDR standards for quality and regulatory adherence, aiding manufacturers in the competitive MedTech field.

Why ISO 14155 Matters in the Context of MDR

ISO 14155, established by the International Organization for Standardization, provides a comprehensive framework for conducting clinical investigations with high ethical and scientific standards, aligning closely with the principles of the MDR. Adherence to ISO 14155 helps compliance with MDR, especially for clinical investigations, by emphasizing the protection of subjects, ensuring data integrity, and maintaining the quality and validity of research findings.

Benefits of Choosing an ISO 14155 CRO for MDR Clinical Investigations

Enhanced Quality and Reliability of Clinical Data: Adhering to ISO 14155 ensures that CROs implement quality control measures and data management practices that align with MDR requirements, leading to more reliable and trustworthy research findings.
Reduced Regulatory Risks and Delays: A CRO with ISO 14155 certification is well-equipped to navigate the MDR landscape, minimizing the risk of non-compliance, which is critical for timely and successful clinical investigations.
Improved Patient Safety: In line with MDR’s focus on patient safety, ISO 14155-compliant CROs prioritize participant well-being, implementing robust risk management and ethical guidelines.
Global Recognition in the MDR Era: ISO 14155 certification holds significant weight under the MDR, enhancing a CRO’s reputation for commitment to quality and compliance.
MDR-Specific Expertise and Experience: CROs compliant with ISO 14155 bring valuable insights and experience in conducting clinical trials that meet both ISO and MDR standards, offering expert guidance throughout the development process.

Conclusion

In the medical device sector, especially under the EU Medical Device Regulation, partnering with a CRO that is compliant with ISO 14155 is a strategic decision for success. MDx, as a CRO adept in both ISO 14155 and MDR requirements, offers a comprehensive approach to ensure patient safety, data integrity, and regulatory compliance. This makes MDx an excellent choice for manufacturers aiming to meet the high standards of the MDR and succeed in the competitive medical device market.

Why Choose MDx as Your Medical Device CRO Partner for ISO 14155 Compliance

MDx stands out as a preferred partner for manufacturers and sponsors in the MDR-regulated environment. Our compliance with ISO 14155 ensures that we are not only aligned with international standards but also adept at navigating the specific requirements of the MDR for clinical investigations. Our team offers:

MDR and ISO 14155 Expertise: Ensuring that your clinical trials meet all regulatory requirements for safety and efficacy.
Commitment to Quality and Integrity: Prioritizing the quality of clinical data, which is essential under the MDR.
Efficient and Cost-Effective Solutions: Streamlining the development process to comply with MDR, reducing delays and costs.
Global Recognition and Network: Enhancing the credibility of your product in the global market, a key aspect in the MDR era.

Written by:

Carlos Galamba

With more than 18 years of experience in the IVD sector, including hands-on work as a scientist in transfusion medicine and infectious disease diagnostics, and regulatory review experience at BSI, one of the EU's largest Notified Bodies, Carlos Galamba brings a uniquely integrated perspective to IVD regulatory strategy. Their work spans Class C/D IVDs, companion diagnostics, NGS-based assays, and software-based IVDs, with a current advisory role to the European Commission on regulatory matters. At MDx CRO, they lead regulatory strategy for complex IVD programs across EU IVDR, FDA, and global markets.

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Importing Investigational Devices for Clinical Investigation in Europe | EU MDR Guide

Written by Alberto Bardaji de Qixano Published on 03.12.2023 Last updated on 16.06.2026

December 3, 2023

Importing investigational devices into Europe under the EU MDR is a complex process that requires strict compliance with regulatory provisions before a clinical investigation can begin. The Medical Device Regulation (MDR) establishes rigorous rules for the entry of investigational devices into the European Union, detailing specific obligations for manufacturers and sponsors. Partnering with a specialized Medical Device Contract Research Organization (CRO) ensures a seamless pathway to compliance and successful device importation.

Essential MDR Provisions for Investigational Device Importation

The MDR delineates vital requirements for the importation of investigational devices:

Designation of an EU Legal Representative: Non-EU entities must appoint a representative within the EU to ensure adherence to MDR regulations. (See MDR Article 62)
Conformity with Labeling Standards: Labels on investigational devices must comply with MDR stipulations, encompassing usage instructions, risk information, and device safety and performance details. Compliance with specific language and symbol requirements is essential. (See MDR Annex I Chapter III)
Demonstration of compliance with the applicable GSPR: This encompasses, when applicable, conducting technical and biological safety assessments, along with pre-clinical evaluations. It also involves implementing measures in occupational safety and accident prevention, all while considering the current state of the art. (See MDR Article 62.4.l)
Adverse Event Surveillance: Manufacturers and sponsors are obligated to implement a system for tracking and reporting adverse events associated with the investigational device over its entire usage period, adhering to defined adverse event criteria and reporting timelines. (See MDR Article 80)
Compliance with MDR Article 21: Importation must adhere to MDR Article 21, ensuring the free movement of investigational devices within the EU for clinical investigation.

Role of a Medical Device CRO in Investigational Device Importation

A Medical Device CRO offers comprehensive support:

Regulatory Guidance: CROs provide deep insights into MDR complexities and keep abreast of regulatory updates.
Labeling Assistance: They ensure investigational device labeling is in full compliance with MDR.
Adverse Event Reporting System Establishment: CROs facilitate setting up compliant adverse event reporting systems.
EU Regulatory Communication: CROs act as liaisons with EU regulatory bodies, managing necessary communications on behalf of manufacturers.
Documentation and Submission Management: From preparing technical documents to managing submissions and responses to EU authorities, CROs play a pivotal role.

Benefits of Collaborating with a Medical Device CRO

Partnering with a CRO offers numerous advantages:

Simplified Regulatory Compliance: CROs handle regulatory complexities, freeing manufacturers to concentrate on development.
Reduced Compliance Risks: Expert advice from CROs minimizes the risks of non-compliance.
Efficient Market Entry: CROs expedite the process of bringing investigational devices to the EU market.
Cost Efficiency: By streamlining the importation process, CROs help in curtailing unnecessary costs.
Expertise Access: CROs offer specialized knowledge in medical device regulation and market entry strategies.

Conclusion

Navigating the MDR for the importation of investigational devices for clinical investigation demands diligent regulatory adherence and strategic planning. Engaging an experienced Medical Device CRO is key to ensuring a compliant and efficient pathway for bringing innovative investigational devices to the EU market.

MDx CRO: Your Strategic Partner for Investigational Device Importation

MDx CRO, a leader in Medical Device CRO services, excels in assisting sponsors and manufacturers through the MDR’s complexities. Our team, proficient in the nuances of the MDR, provides end-to-end support, ensuring your investigational devices are compliantly and effectively introduced into the European market.

With MDx CRO, you gain a partner committed to a compliant, streamlined, and successful introduction of your investigational devices in the EU. Contact us to discover how our expertise can enhance your clinical investigation endeavors.

*MDx offers assistance with the importation of investigational devices. MDx’s range of services does not include acting as an economic operator importer as defined under Article 13 of the EU MDR.

Written by:

Alberto Bardaji de Qixano

Master of Engineering with close to 20 years of international experience in product development, regulatory affairs and market access of Medical Devices. Authorized MDR and ISO 13485 QMS Auditor.

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Importing IVDs for Performance Studies | EU IVDR Guide

Written by Carlos Galamba Published on 03.12.2023 Last updated on 16.06.2026

December 3, 2023

The In Vitro Diagnostic Medical Devices Regulation (IVDR) has introduced a stringent regulatory framework for the importation of In Vitro Diagnostic Medical Devices (IVDs) into the European Union (EU) under the IVDR. This framework imposes specific requirements on sponsors and manufacturers who intend to import IVDs for performance studies. To ensure compliance and facilitate a smooth importation process, engaging an experienced IVD CRO (Contract Research Organization) can be invaluable.

IVDR Article 19 is relevant to the importation of IVDs for performance studies in that it establishes the right of sponsors and manufacturers to import IVDs into the EU for the purpose of conducting performance studies. However, it is important to note that the IVDR also imposes certain requirements on the importation of IVDs for performance studies.

Importing IVDs for Performance Studies

The are several key requirements for importing IVDs for performance studies under EU IVDR:

Appointment of a Legal Representative: Non-EU sponsors must appoint a legal representative within the EU fro their clinical performance studies. This representative is responsible for ensuring compliance with the IVDR sponsor’s obligations , and shall be the addressee for all communications with the sponsor provided for in this Regulation. (IVDR Article 58)
Labeling Requirements: Labeling must be in accordance with the IVDR’s labeling requirements, which include information on the intended use, risks, and performance of the IVD. Specific requirements include appropriate language, symbols, and hazard indications.
Adverse Event Reporting: Sponsors and manufacturers must establish and maintain systems for reporting adverse events associated with the IVD throughout its lifecycle. This includes defining what constitutes an adverse event and adhering to specified timelines for reporting. (IVDR Article 82)
Compliance with IVDR Article 19: Ensure that the importation of IVDs for performance studies adheres to the principles of freedom of movement. (IVDR Article 19)

The Role of an IVD CRO in Importation

An experienced IVD CRO can provide comprehensive support to sponsors and manufacturers throughout the importation process, ensuring adherence to the IVDR’s requirements and streamlining the regulatory pathway.

Regulatory Expertise: IVD CROs possess in-depth knowledge of the IVDR, including staying updated on changes or updates to the regulation, and can guide sponsors and manufacturers through the complex regulatory landscape.
Labeling Review: CROs can assist in reviewing and preparing labeling in accordance with the IVDR’s requirements.
Adverse Event Reporting Procedures: CROs can assist in establishing and implementing adverse event reporting procedures that comply with the IVDR’s requirements.
Communication and Representation: CROs can effectively communicate with EU authorities, representing sponsors and manufacturers during interactions and negotiations, and act as intermediaries for any necessary correspondence.
Documentation Preparation: CROs can assist in preparing and compiling the necessary documentation, including technical files, risk assessments, and labeling.
Submission and Review Management: CROs can manage the submission process, ensuring timely and accurate submissions to EU authorities and addressing any review comments promptly.

Benefits of Engaging an IVD CRO

Engaging an IVD CRO offers several significant benefits for sponsors and manufacturers:

Reduced Regulatory Burden: CROs take on the regulatory burden, allowing sponsors and manufacturers to focus on their core research activities.
Enhanced Compliance: CROs’ expertise helps minimize the risk of non-compliance, preventing delays and potential penalties.
Streamlined Importation Process: CROs facilitate a smooth and efficient importation process, expediting the availability of IVDs for performance studies.
Reduced Costs: CROs can help optimize the importation process, minimizing unnecessary costs and maximizing resource utilization.
Access to Expertise: CROs provide access to a team of experienced professionals with specialized knowledge in IVD regulation.

Conclusion

Importing IVDs for performance studies under the IVDR requires careful consideration of the regulatory landscape and adherence to stringent requirements. Engaging an experienced IVD CRO can provide invaluable support to sponsors and manufacturers, ensuring compliance, streamlining the importation process, and ultimately facilitating the development of innovative IVDs that benefit patient care.

MDx CRO: Your Partner in importation of IVDs for performance studies

MDx CRO is a leading provider of IVD CRO services, with a proven track record of success in helping sponsors and manufacturers navigate the IVDR regulatory landscape. Our team of experts possesses in-depth knowledge of the IVDR and can provide comprehensive support throughout the importation process. With specific examples of our past successes, we demonstrate our expertise and experience in the field.

With MDx CRO as your partner, you can rest assured that your IVD importation process will be compliant, efficient, and cost-effective. Contact us today to learn more about how we can help you bring your innovative IVDs to the European market.

*MDx offers assistance with the importation of devices for performance studies. MDx’s range of services does not include acting as an economic operator importer as defined under Article 13 of the EU IVDR.

Written by:

Carlos Galamba

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The Role of a IVDR Legal Representative in Clinical Performance Studies

Written by Carlos Galamba Published on 03.12.2023 Last updated on 16.06.2026

December 3, 2023

In the field of medical device regulation, the European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR) exemplifies the EU’s commitment to patient safety and high standards of device performance. Central to this regulation is Article 58, which stipulates the requirement for non-EU sponsors of clinical performance studies to appoint a legal representative within the EU. This provision is integral to ensuring these studies align with the EU’s stringent regulatory standards. This article highlights the vital role of the legal representative under Article 58 of the IVDR in ensuring compliance of clinical performance studies.

Understanding IVDR Article 58

The IVDR plays a crucial role in safeguarding the safety and performance of in vitro diagnostic medical devices (IVDs). Article 58 mandates the appointment of a legal representative in the EU for clinical performance studies initiated by sponsors outside the EU. This requirement is not just a procedural step; it is a strategic measure to ensure adherence to the EU’s rigorous regulatory framework.

Role and Responsibilities of the IVDR Legal Representative following article 58.

The legal representative serves as an essential link between the sponsor and the EU’s regulatory bodies. Their responsibilities include:

Communication Facilitator: Acting as the main contact for EU regulatory authorities, addressing questions and ensuring effective communication.
Regulatory Compliance: Ensuring that the clinical performance studies comply with all relevant IVDR requirements, encompassing ethical standards, patient safety, and data protection.
Documentation Management: Maintaining comprehensive and accurate records of the study, including protocols, reports, and patient data.
Sponsor Representation: Representing the sponsor in interactions with EU authorities and providing expert guidance throughout the study process.
Documentation Submission and Review: Assisting in the preparation and submission of necessary documentation to EU authorities for timely and thorough review.

Advantages of Engaging a IVDR Legal Representative in Clinical Performance Studies

Appointing a legal representative offers several benefits:

Regulatory Burden Reduction: They possess an in-depth understanding of the IVDR, allowing sponsors to focus on research without the complexities of regulation.
Compliance Enhancement: Their expertise ensures studies adhere to all IVDR requirements, minimizing the risk of non-compliance.
Effective Regulatory Communication: They facilitate smooth interactions with EU authorities, overcoming potential language barriers.
Risk Mitigation: Early identification and resolution of compliance issues prevent delays.
Expedited Approval Processes: Their knowledge of the regulatory landscape can accelerate the approval process, bringing IVDs to the market more swiftly.

The Intersection with ISO 20916

In the realm of in vitro diagnostic medical devices (IVDs), the intersection of the European Union’s IVDR, particularly Article 58, with ISO 20916:2019 is a pivotal point for ensuring the highest standards in clinical performance studies. ISO 20916:2019 provides a comprehensive framework for the design, conduct, and reporting of these studies, ensuring their validity, reliability, and compliance with international ethical and regulatory requirements.

This intersection is critical for several reasons:

Harmonization of Standards: ISO 20916:2019 complements the IVDR by offering an internationally recognized standard for clinical performance studies. This harmonization is particularly beneficial for non-EU sponsors required to appoint a legal representative under Article 58 of the IVDR. By aligning their studies with ISO 20916, sponsors can ensure global acceptance of their data while meeting EU-specific regulatory requirements.
Enhanced Regulatory Compliance: The legal representative’s role, as outlined in Article 58, extends to ensuring that the clinical performance studies not only comply with the IVDR but also adhere to the quality and reliability standards set by ISO 20916. This dual compliance enhances the credibility and acceptability of the study outcomes.
Quality and Safety Assurance: ISO 20916’s focus on rigorous methodology, data integrity, and ethical considerations strengthens the safety and performance evaluation of IVDs. When combined with the IVDR’s emphasis on patient safety and effective regulatory oversight, this leads to a more robust and trustworthy assessment of IVDs.
Streamlined Approval Process: Understanding and implementing the requirements of ISO 20916 can facilitate a smoother approval process within the EU regulatory framework. The legal representative’s expertise in both ISO 20916 and the IVDR can expedite the review and approval of clinical performance studies, ultimately accelerating the time-to-market for innovative IVDs.

In conclusion, the integration of ISO 20916:2019 into the IVDR framework, especially under the auspices of Article 58, represents a strategic and operational synergy. It ensures that clinical performance studies of IVDs not only meet the EU’s stringent regulatory requirements but also align with global best practices, paving the way for advanced medical technologies.

Selecting an Appropriate Legal Representative in IVD.

Choosing the right legal representative is critical for the success of clinical performance studies:

Experience: A proven history of managing IVDR clinical performance studies successfully is essential.
Expertise: In-depth knowledge of the IVDR is crucial.
Communication Skills: They should emphasize clear and consistent communication with the sponsor.
Networking Abilities: A robust network within the EU regulatory framework is advantageous for insights and connections.

Conclusion

The appointment of a legal representative under Article 58 of the IVDR is a crucial step for non-EU sponsors aiming to conduct clinical performance studies in the EU. This role is more than a regulatory requirement; it is a key element in navigating the EU’s regulatory landscape and ensuring compliance with the IVDR’s strict standards. With the appropriate legal representative, sponsors can focus on their primary objective: advancing medical science and improving patient outcomes through innovative in vitro diagnostics.

Written by:

Carlos Galamba

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MDR Article 62.2: The Role of Clinical Investigation Legal Representative

Written by Alberto Bardaji de Qixano Published on 25.11.2023 Last updated on 16.06.2026

November 25, 2023

In the intricate world of medical device regulation, the European Union Medical Device Regulation (EU MDR) stands out as a beacon of stringent and comprehensive rules. Among its many provisions, Article 62.2 introduces a pivotal requirement for clinical investigation sponsors outside the European Union. This article delves into the crucial role of a legal representative mandated by this regulation and how it intersects with the ISO 14155 standards for clinical investigations.

Understanding EU MDR Article 62.2

The EU MDR, a cornerstone in medical device regulation, aims to ensure the highest level of safety and performance of medical devices. Under Article 62.2, non-EU sponsors of clinical investigations must appoint a legal representative within the EU. This mandate is more than a procedural formality; it’s a strategic move ensuring that all clinical investigations adhere to the EU’s rigorous standards.

The Legal Representative’s Role and Responsibilities

The legal representative acts as the linchpin, bridging the gap between the sponsor and the EU’s regulatory environment. Their duties are multifaceted and critical:

Communication Conduit: Acting as the primary contact for EU authorities.
Regulatory Compliance: Ensuring adherence to EU MDR obligations.
Documentation Oversight: Maintaining detailed records of clinical investigations.
Representation: Advocating for the sponsor in discussions with EU authorities.
Submission and Review Facilitation: Aiding in the efficient handling of necessary documentation.

Throughout the clinical investigation, from inception to conclusion, the legal representative is instrumental in aligning the sponsor’s operations with the EU MDR’s expectations.

Benefits of Engaging a Legal Representative

Appointing a legal representative is not just a regulatory checkbox but a strategic advantage:

Reduced Regulatory Burdens: They navigate the complexities of the EU MDR, allowing sponsors to focus on their core research activities.
Enhanced Compliance: With deep insights into the EU MDR, legal representatives ensure effective adherence to the regulations.
Streamlined Regulatory Interactions: They facilitate smooth communication with EU authorities, removing potential barriers.
Mitigated Risk of Non-Compliance: Their expertise helps avoid pitfalls that could derail the investigation.
Accelerated Timelines: Understanding the regulatory landscape enables quicker approval processes.

Selecting the Right Legal Representative

Choosing an effective legal representative hinges on several factors:

Experience: A history of successful EU clinical investigation management is crucial.
Expertise: In-depth knowledge of the EU MDR is non-negotiable.
Communication: They should ensure transparency and regular updates.
Network: A robust network within the EU regulatory framework can be invaluable.

The Intersection with ISO 14155

The role of a legal representative under the EU MDR complements the ISO 14155 standards, which govern the conduct of clinical investigations for medical devices. Together, they form a robust framework ensuring that clinical investigations meet the highest standards of quality and regulatory compliance.

Conclusion

The appointment of a legal representative under Article 62.2 of the EU MDR is a crucial step for non-EU sponsors aiming to conduct clinical investigations in the EU. This role is not only a regulatory requirement but a vital element in navigating the EU’s regulatory landscape, in line with ISO 14155 standards. With the right legal representative, sponsors can focus on their primary objective – advancing medical science and patient care.

Written by:

Alberto Bardaji de Qixano

Master of Engineering with close to 20 years of international experience in product development, regulatory affairs and market access of Medical Devices. Authorized MDR and ISO 13485 QMS Auditor.

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Understanding MDCG 2020-13: A Guide for Medical Device Manufacturers Preparing Clinical Evaluation Reports

Written by Alberto Bardaji de Qixano Published on 01.10.2023 Last updated on 05.06.2026

October 1, 2023

Last update

05.06.2026

The Medical Device Coordination Group (MDCG) shapes how medical devices are assessed in the European Union. One of its most influential documents is MDCG 2020-13, a guideline that explains how manufacturers should prepare Clinical Evaluation Reports (CERs) under the EU Medical Device Regulation (MDR). For any company aiming to place a device on the EU market, understanding MDCG 2020-13 for Manufacturers is essential.

Why MDCG 2020-13 Matters for Manufacturers

The MDR introduced a stricter and far more structured compliance framework. Clinical Evaluation Reports are no longer a formality—they are central to demonstrating safety, performance, and clinical benefit.

MDCG 2020-13 for Manufacturers provides the roadmap for building a CER that meets MDR expectations. Aligning with this guidance improves the quality of your Technical Documentation and significantly strengthens your chances of regulatory approval.

Clinical evaluation is now a continuous process, and MDCG 2020-13 ensures manufacturers understand what data to collect, how to justify it, and how to present it.

How MDCG 2020-13 Shapes the Clinical Evaluation Process (CER)

MDCG 2020-13 serves as a practical reference for structuring clinical evidence. It explains what the CER must include and aligns its structure with MDR Annex XIV, ensuring manufacturers remain fully compliant with current regulations.

The guideline helps manufacturers:

Understand the level of clinical data required
Present evidence in a regulatory‑ready format
Show benefit‑risk alignment with MDR safety principles

For manufacturers, this guidance reduces ambiguity and supports consistent, defensible clinical evaluations.

What You Need to Know About Aligning CERs With the CEAR Format

Manufacturers may structure their Clinical Evaluation Report to follow the Clinical Evaluation Assessment Report (CEAR) used by Notified Bodies.
Why does this matter?

It creates a smoother review process
It improves clarity and traceability
It anticipates NB expectations

Using the CEAR structure is not mandatory, but it can streamline regulatory interactions and reduce back‑and‑forth during conformity assessments.

Key Goals of the Clinical Evaluation Plan Under MDCG 2020‑13

MDCG 2020-13 reinforces the importance of a well‑defined Clinical Evaluation Plan (CEP). Manufacturers must align it with MDR Annex XIV Part A Section 1a. The CEP should clearly define:

✔ General Safety and Performance Requirements (GSPRs)

Identify which GSPRs require clinical evidence and describe how that evidence will be generated.

✔ Intended Purpose

Ensure consistency across the CER, IFU, labeling, and promotional materials.

✔ Target Populations and Indications

Include patient groups, contraindications, and specific clinical conditions.

✔ Clinical Benefits and Outcome Measures

Define measurable clinical outcomes linked to meaningful patient benefit.

✔ Clinical Safety Methods

Explain how both qualitative and quantitative aspects of safety will be assessed.

✔ Benefit‑Risk Parameters

List all metrics and criteria used to justify the benefit‑risk determination.

✔ Special Considerations for Combination Products

Address components such as medicinal substances, tissues of animal origin, or human derivatives.

✔ Clinical Development Plan

Include milestones and acceptance criteria—even if only high level.

A well‑designed CEP sets the foundation for a successful clinical evaluation and a strong CER.

Aligning IFU, Promotional Materials, and the CER Using MDCG 2020-13

One of the most practical aspects of MDCG 2020-13 for Manufacturers is its guidance on aligning all outward‑facing documents with the CER.

Here’s what manufacturers must evaluate:

Information Materials

Review IFUs, labeling, SSCPs, and promotional materials to ensure they reflect the evidence presented in the CER.

Intended Purpose

The intended purpose described in the CER must match exactly what appears in the IFU and promotional claims.

Patient Population and User Groups

Ensure consistency in population definitions and user profiles (HCP vs. lay user).

Warnings, Contraindications, and Precautions

Verify that safety information in the IFU is backed by data in the CER and risk management file.

Training Requirements

If user training is needed, justify this in both the risk management documentation and the CER.

Associated Risks and Residual Risks

Ensure risk descriptions align across the CER, IFU, PMS/PSUR, and RMF.

This alignment not only supports MDR compliance but also ensures safe, transparent communication to patients and users.

By aligning these documents in accordance with MDCG 2020-13, manufacturers not only assure compliance but also build a strong foundation for market success, bolstered by robust clinical evidence and transparent communication.

How to Incorporate these Aspects in Your Clinical Evaluation

1. Start With a Gap Analysis

Compare your existing CER and CEP against the MDCG 2020-13 requirements.
This identifies missing data, unclear claims, or inconsistencies.

2. Use a Multidisciplinary Team

Combine expertise from clinical, regulatory, engineering, and risk management.
This ensures your CER is scientifically sound and fully compliant.

3. Update Documentation

Revise the CEP, CER, and supporting Technical Documentation based on identified gaps.

4. Ensure Consistent Device Descriptions

Match the device description across the CER, IFU, marketing materials, and SSCP.

5. Integrate All Available Clinical Data

Include pre‑clinical data, clinical investigations, PMS results, PMCF findings, and real‑world evidence.

6. Leverage PMS and PSUR Insights

Use post‑market data to strengthen the CER and ensure continuous compliance.

7. Align With the Risk Management File

Make sure risk‑related statements remain consistent across all documents.

By taking these steps, manufacturers can confidently align with MDCG 2020-13, strengthen their clinical evidence, and support a smooth Notified Body review.

What is MDCG 2020-13?

MDCG 2020-13 is a guidance document issued by the Medical Device Coordination Group that provides a standardized Clinical Evaluation Assessment Report (CEAR) template. While it is technically designed for Notified Bodies to document their review of a manufacturer’s clinical data, it serves as an invaluable “open-book exam” for medical device manufacturers looking to understand exactly how their Clinical Evaluation Reports (CER) will be audited under the EU MDR.

Why should manufacturers use a template meant for Notified Bodies?

By reverse-engineering the MDCG 2020-13 template, manufacturers can see the exact questions, criteria, and evidence structures that a Notified Body reviewer will look for. Designing your Clinical Evaluation Plan (CEP) and CER to match the sections of this template (Sections C through H) minimizes structural gaps, avoids common misalignments, and dramatically reduces first-round review questions or delays.

Can I still claim device equivalence under MDCG 2020-13?

Yes, but the scrutiny is exceptionally high. Notified Bodies will use the guidance to stringently evaluate the technical, biological, and clinical dimensions of your equivalence claim. If you claim equivalence to an existing device, you must have complete, legitimate access to its technical data, and you must scientifically prove that any minor differences do not impact clinical safety or performance.

Why MDCG 2020-13 for Manufacturers Is a Strategic Advantage

This guideline is far more than a compliance requirement. It helps manufacturers:

Build stronger, defensible clinical evidence
Reduce regulatory delays
Improve device safety and performance claims
Strengthen market readiness
Ensure consistent messaging across all documentation

With MDCG 2020-13, manufacturers can elevate the quality and credibility of their clinical evaluations—while accelerating time‑to‑market under the MDR.

Written by:

Alberto Bardaji de Qixano

Master of Engineering with close to 20 years of international experience in product development, regulatory affairs and market access of Medical Devices. Authorized MDR and ISO 13485 QMS Auditor.

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MDx: Your Dedicated CRO for IVD Clinical Studies in the EU

Written by Carlos Galamba Published on 24.08.2023 Last updated on 03.10.2025

August 24, 2023

Introduction

In the rapidly evolving world of in vitro diagnostics (IVD), manufacturers are increasingly understanding the need for rigorous clinical performance studies. Such studies form the backbone for ensuring the safety, efficiency, and overall market readiness of IVD devices. With the European Union’s (EU) stringent regulatory environment, conducting these studies requires expertise and precision. That’s where MDx CRO, a trusted name in IVD Contract Research and regulatory consulting, stands out.

Why are IVD Clinical Studies Imperative?

Evidence-based Decision Making: Clinical performance studies furnish the data that can prove the diagnostic accuracy, precision, and utility of IVD devices. They help manufacturers refine their offerings and justify their product claims.
Regulatory Adherence: Ensuring compliance with the EU’s In Vitro Diagnostic Regulation (IVDR) and standards like ISO 20916 is non-negotiable. Clinical studies often form the bedrock in gaining these credentials and opening up the European market.

Navigating the Challenges with MDx CRO

Whether you’re a fledgling startup or an established IVD giant, challenges like site selection, study design, effective monitoring, and regulatory adherence can be daunting. This is where MDx CRO can be your guiding light:

Proven Expertise: With its legacy in the IVD realm and former Notified Body experts on board, MDx CRO offers unparalleled insights into effective study design, ensuring manufacturers derive actionable insights every time.
Network of Clinical Sites: Owing to its years in the industry, MDx CRO has built strong affiliations with leading clinical sites, guaranteeing timely and efficient study conduct.
Regulatory Insight: Navigating the IVDR and ISO 20916 maze becomes simpler with MDx CRO’s regulatory consulting wing, which ensures manufacturers always stay on the right side of the law.
End-to-End Monitoring: With a keen focus on detail, MDx CRO ensures every study stays on track, protocols are maintained, and data integrity remains uncompromised.

Why MDx CRO?

Simply put, MDx CRO isn’t just a service provider – it’s a partner in your IVD journey. Our seasoned team understands the unique challenges IVD manufacturers face, making them an indispensable asset in your product’s journey from concept to the European market.

Conclusion

IVD clinical studies, while challenging, present a golden opportunity to IVD manufacturers to rigorously validate their product’s claims. In the intricate web of EU regulations, manufacturers need more than just expertise; they need a partner. And who better than MDx CRO, which has consistently demonstrated excellence in study design, monitoring, and ensuring complete regulatory compliance? Choose MDx CRO, and let’s work together to bring transformative and reliable IVD devices to the EU market.

FAQs about IVD Clinical Studies and MDx CRO:

What are IVD Clinical Studies?
- IVD clinical studies refer to rigorous research and evaluations conducted to determine the safety, efficiency, and overall performance of in vitro diagnostic (IVD) devices.
Why are IVD Clinical Studies important in the EU?
- The EU has stringent regulatory requirements. IVD clinical studies provide the necessary evidence to support product claims, ensuring compliance with the EU’s In Vitro Diagnostic Regulation (IVDR) and international standards like ISO 20916.
What challenges can manufacturers expect while conducting IVD studies in the EU?
- Manufacturers may face challenges like site selection, creating an effective study design, regular study monitoring, and ensuring compliance with EU regulations and standards.
How does MDx CRO help with these challenges?
- MDx CRO offers expertise in study design, has affiliations with top clinical sites, provides regulatory consulting for EU standards, and ensures end-to-end study monitoring to maintain the quality and integrity of data.
Is MDx CRO suitable for both startups and established manufacturers?
- Absolutely! Whether you’re a startup entering the IVD market or a seasoned manufacturer, MDx CRO’s tailored solutions cater to the unique needs of every client.
How does MDx CRO ensure compliance with the IVDR and ISO 20916?
- MDx CRO boasts a regulatory consulting wing with deep knowledge of IVDR and ISO 20916, ensuring manufacturers receive accurate guidance and assistance throughout their IVD device’s journey to the market. Our team of former Notified Body experts on board help design studies that meet CE mark expectations
What advantages does MDx CRO offer in terms of site selection for IVD studies?
- With its extensive experience and industry connections, MDx CRO has built relationships with leading clinical sites for a variety of technologies and clinical applications, ensuring timely and efficient study initiation and execution.
How does partnering with MDx CRO impact the success rate of IVD devices in the EU market?
- With MDx CRO’s comprehensive services, from design to monitoring and regulatory guidance, manufacturers enhance their chances of a successful and compliant IVD product launch in the EU.
Where can I learn more about MDx CRO’s success stories or case studies?
- It’s best to reach out to MDx CRO directly or visit our website for detailed testimonials, case studies, and more insights into our work.

Written by:

Carlos Galamba

View all articles →

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

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

Carlos Galamba: Your Trusted IVD Consultant and IVDR Expert

Written by Carlos Galamba Published on 10.08.2023 Last updated on 04.10.2025

August 10, 2023

Innovative medical professional specializing in MedTech advancements at MDX, focusing on accelerating healthcare innovation and improving patient outcomes through cutting-edge technology. — Carlos Galamba, CEO MDx CRO

Carlos Galamba, IVD Consultant – MDx CRO Founder

In the intricate landscape of In Vitro Diagnostics (IVD) and the evolving In Vitro Diagnostics Regulation (IVDR), one name stands out as a beacon of expertise and guidance – Carlos Galamba. With a wealth of experience spanning over 18 years in the IVD sector, Carlos is a seasoned consultant who has left an indelible mark on the world of diagnostics.

Pioneering Path to Regulatory Mastery

Carlos’s journey commenced as a biomedical scientist, setting the stage for a remarkable career journey. His trailblazing role as the first in-house clinician for IVDs at BSI (British Standards Institution), a renowned Notified Body, played a pivotal role in shaping the clinical oversight process for hundreds of diagnostics. From genetic tests to molecular assays, point-of-care diagnostics, CDx, LDTs / in-house assays, NGS and beyond, Carlos expertise is unrivaled. This groundbreaking contribution has significantly impacted how the industry approaches regulatory compliance.

Mastering the IVDR Landscape

Carlos Galamba’s expertise extends well beyond his role at BSI. His insights have positioned him as a distinguished external expert for the EU Commission, where he provides invaluable guidance in navigating the intricate IVDR terrain. His strategic acumen has propelled prominent companies like Biomerieux, Cepheid, Leica, Hologic, Abbott, Thermofisher, Werfen and more toward achieving excellence in IVDR compliance.

Guiding Innovation in IVD

At the helm of innovation, Carlos Galamba served as the Vice President of IVD Intelligence & Innovation at RQM+. His technical thought leadership encompassed an array of IVD technologies, ranging from immunoassays to more complex next-generation sequencing tests and IVD Software. Carlos’s insights have led to the development of competitive intelligence strategies that drive expansion and commercialization within the IVD consultancy sector.

A Catalyst for Regulatory Success

Carlos’s dedication to simplifying the complex is the cornerstone of his approach. His tailored solutions empower businesses to navigate the evolving regulatory landscape while gaining a competitive edge. His remarkable achievements, including leading the transition to the new EU medical device legislation (IVDR) at several companies and successfully implementing pivotal regulatory changes, position Carlos Galamba as a catalyst for transformative IVD projects.

Connect with MDx CRO for Regulatory Excellence

Whether you’re an IVD startup with ambitious goals or a global diagnostics manufacturer looking to streamline regulatory processes, Carlos Galamba’s expertise is your compass for regulatory mastery. If your company is seeking unparalleled IVD consulting, don’t hesitate to connect with Carlos and his team at MDx CRO. Together, they bring a wealth of knowledge to guide you through the complexities of IVD regulations.

Connect with Carlos on LinkedIn

In the complex landscape of In Vitro Diagnostics and the evolving IVDR framework, Carlos Galamba’s expertise continues to set the standard for regulatory excellence. His extensive experience and leadership exemplify how deep regulatory insight and practical guidance can shape successful IVD strategies and ensure lasting compliance under the IVDR.

Written by:

Carlos Galamba

View all articles →

Industry Insights & Regulatory Updates

FDA Regulation of In Vitro Diagnostic Devices: The Complete Guide for US Market Entry

ISO 10993-1:2025 From Checkbox Compliance to Risk-Based Biocompatibility

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

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