Consolidating MDCG 2024-5 and ISO 14155 for Medical Devices

The MDR Investigator’s Brochure (IB) is a foundational document in clinical research for medical devices. Under the EU Medical Device Regulation (EU MDR) 2017/745, preparing an Investigator’s Brochure is a mandatory requirement for any clinical investigation. This document consolidates all relevant clinical and non‑clinical data about the investigational device and serves as the primary reference for investigators responsible for conducting MDR‑compliant clinical studies.

The purpose of the MDR Investigator’s Brochure is to ensure that every clinical investigation is supported by robust, transparent, and scientifically sound information. It provides investigators with the knowledge necessary to evaluate device performance, understand potential risks, and ensure patient safety throughout all study phases.

To meet MDR expectations, the IB must be developed in alignment with ISO 14155, the international standard governing Good Clinical Practice for medical device clinical investigations. ISO 14155 specifies how clinical studies must be designed, conducted, recorded, and reported, and the Investigator’s Brochure plays a central role in ensuring compliance with these principles.

In addition, MDCG 2024‑5 offers further guidance on the structure and content of the MDR Investigator’s Brochure. This MDCG document stresses clarity, completeness, and scientific rigor, ensuring the IB provides a comprehensive overview of the investigational device. It highlights the need for detailed information on device design, intended purpose, manufacturing, prior clinical experience, and risk–benefit considerations, elements essential for informed clinical oversight.

Beyond summarizing design and safety information, the MDR Investigator’s Brochure compiles clinical evidence from previous bench tests, preclinical studies, and human data (where available). This evidence synthesis supports ethical review, risk assessment, and regulatory submission, forming the backbone of a well‑prepared clinical investigations. plan. Ultimately, a high‑quality Investigator’s Brochure strengthens both regulatory compliance and patient protection, ensuring that investigational devices are evaluated responsibly and scientifically.

MDR investigator´s brochure: Regulatory Context and Importance

Regulated by EU MDR 2017/745

The European Union Medical Device Regulation (EU MDR) sets strict requirements for clinical investigations in the EU. Article 71.4 references the Investigator’s Brochure (IB) twice and clearly defines what it must contain.

According to this article, the IB must present comprehensive information about the investigational device. It should also reflect the current state of scientific knowledge. This ensures the device can demonstrate safety, performance, and clinical benefits during the investigation.

Article 71.4 explicitly requires a detailed description of the device. This includes its intended use, risk classification, design features, and manufacturing details. It must also include all necessary clinical and non‑clinical data available at the time of submission.

Together, these elements ensure the investigational device is properly assessed before and during clinical investigations. They also help investigators confirm that the device is used safely, consistently, and in line with MDR expectations.

Standardized by ISO 14155

ISO 14155 mentions the Investigator’s Brochure (IB) four times and sets the standard for good clinical practice in clinical investigations involving human subjects. It defines how studies must be designed, conducted, recorded, and reported.

In Section 6.5 and Annex B, ISO 14155 outlines the core requirements for the IB. It states that the IB must give principal investigators sufficient safety and performance data from pre‑clinical studies and previous clinical investigations. This information helps investigators understand the device and use it safely during the study.

Moreover, ISO 14155 requires that the IB remain continuously updated. As new, relevant information emerges during a clinical investigation, sponsors must revise the IB. This ensures the document stays accurate, current, and comprehensive throughout the study lifecycle.

Detailed in MDCG 2024-5

MDCG 2024‑5 provides detailed guidance on what the MDR Investigator’s Brochure must include to support a clinical investigation application. This document clarifies how sponsors should compile the IB so it fully meets regulatory expectations and facilitates an efficient review by competent authorities.

The guidance also stresses the importance of clear, balanced, and non‑promotional content. Using this approach ensures investigators receive reliable information and can make informed decisions about participating in the clinical investigation.

Structuring the MDR Investigator´s Brochure: A Detailed Approach

1. Device Description and Specifications

The detailed description of the investigational device forms a crucial part of the Investigator´s Brochure (IB). This section must provide a thorough overview of the device, including its design, operational mechanics, and the scientific rationale behind its development. The aim is to furnish investigators with the necessary information to understand the device’s functionality, potential clinical applications, and safety features.

General Information

• Device Identification: This includes the official name, model number, and any other identifiers unique to the device. It’s essential to maintain consistency in terminology throughout the IB to avoid confusion.
• Regulatory Status: Details about the device’s approval status, including whether it is under investigation or already approved for use in other contexts or regions. This should align with the regulatory requirements of the EU MDR and include any CE marking statuses.

Technical Details

• Design Overview: A comprehensive description of the device’s design, highlighting any innovative features. This should cover the underlying technology, operational principles, and any software components integral to the device’s function.
• Materials and Components: Detailed information about the materials used in the device’s construction, especially those in contact with patients. Information on biocompatibility must be included as per ISO 10993-1 standards, ensuring that all materials are safe for intended use scenarios.
• Manufacturing Process: Insight into the manufacturing processes, including quality control measures and compliance with current good manufacturing practices (cGMP). This transparency helps assure investigators of the device’s reliability and consistency in production.

Operational Mechanics

• Mechanism of Action: Explanation of how the device achieves its intended medical purpose. This includes a description of any mechanical, electronic, or biological actions that are central to the device’s operation.
• Instructions for Use: Clear, step-by-step instructions on how the device should be operated during the clinical investigations, including setup, usage, and shutdown procedures, if applicable. This section should also address any training requirements for investigators or clinical staff.

Safety Features

• Safety Mechanisms: Details of built-in safety features designed to protect the patient and user, such as automatic shut-offs, error alerts, and fail-safes.
• Known Risks and Mitigation Strategies: An overview of identified risks associated with the device, along with strategies implemented to mitigate these risks. This should be directly linked to the risk management processes detailed in a later section of the IB.

This section of the IB serves not only to inform but also to build confidence among clinical investigators and regulatory bodies regarding the investigational device’s suitability for clinical investigations. By providing a clear and detailed description of the device, the IB helps ensure that all stakeholders have a deep understanding of the device’s capabilities, safety, and potential impact on patient health.

2. Clinical and Non-Clinical Data

This section of the IB comprehensively details the investigational device’s performance in both pre-clinical and clinical settings. It should offer a thorough summary of all relevant studies, ensuring that investigators have access to comprehensive data that supports the safety and performance of the device.

Pre-Clinical Studies

• Overview of Studies: A summary of all pre-clinical studies conducted, including laboratory, in vitro, in vivo (animal studies), and any biomechanical or biochemical research relevant to the device’s intended use. This should include detailed results and interpretations.
• Safety and Performance Data: Detailed findings from pre-clinical tests that assess the safety and performance of the device. This includes any biocompatibility testing done in accordance with ISO 10993, mechanical and durability testing, and any other relevant safety evaluations.
• Regulatory Compliance: Explanation of how pre-clinical testing complies with relevant regulations and standards, including any deviations from standard protocols and justifications for such deviations.

Clinical Data

• Summary of Clinical Investigations: A detailed account of previous and ongoing clinical investigations involving the device, including study design, methodology, sample size, duration, endpoints, and primary outcomes. This should include both published and unpublished data.
• Safety and Performance Outcomes: Analysis of data related to the device’s safety and performance from clinical investigations, highlighting any significant adverse events, device deficiencies, and corrective actions taken.
• Comparative Analysis: If applicable, comparative data from similar devices or previous versions of the same device, providing a contextual understanding of the investigational device’s performance.

Integration of Data

• Data Correlation: Correlate pre-clinical findings with clinical outcomes to illustrate how earlier studies have informed clinical investigation designs and expectations.
• Rationale for Clinical Investigation: Based on the integrated data, provide a comprehensive rationale for proceeding with further clinical investigations, outlining expected benefits, potential risks, and overall clinical value of the device.

Justification of Clinical Relevance

• Scientific Literature: Review and summarize relevant scientific literature that supports the use, safety, and performance of the device. This should include any meta-analyses, systematic reviews, and key opinion papers.
• Regulatory Considerations: Discuss any regulatory feedback or advisories that have impacted the clinical development of the device, including any special designations or regulatory pathways that are being utilized.

This section of the IB is critical for establishing the scientific and clinical foundation upon which the clinical investigation is based. It must convincingly demonstrate that the investigational device has been thoroughly evaluated in non-clinical settings and that the data derived from these evaluations justify its examination in human subjects. By providing clear, comprehensive, and scientifically sound data, this section helps ensure that the clinical investigation proceeds with a well-defined understanding of the device’s potential impacts on patient safety and performance.

3. Risk Management

Overview of Risk Assessment

• Risk Identification: Detail all potential risks associated with the use of the device, derived from pre-clinical studies, historical data from similar devices, and initial clinical investigations. This should include both device-specific and procedure-related risks.
• Risk Analysis: Evaluate the likelihood and potential impact of identified risks. Use qualitative and quantitative methods to assess how these risks could affect patient safety and the reliability of study results.

Risk Control Strategies

• Risk Mitigation Measures: Outline specific strategies and actions taken to minimize identified risks. This includes design modifications, safety features integrated into the device, and specific procedural steps taken during clinical investigations to mitigate risks.
• Monitoring and Reporting: Procedures for ongoing monitoring of risks throughout the clinical investigation. Detail how adverse events and device deficiencies will be recorded, analyzed, and reported. Include information on the data monitoring committee’s role and any interim analyses planned.

Documentation and Communication of Risks

• Risk Communication Plan: Describe how information about risks is communicated to all stakeholders, including clinical investigation sites, investigators, and participants. Ensure that all parties are aware of potential risks and the measures in place to protect participants.
• Training Programs: Detail training provided to clinical staff and investigators to recognize, manage, and report risks effectively. Training should cover the proper use of the device, recognition of adverse events, and emergency procedures.

Benefit-Risk Analysis

• Overall Benefit-Risk Profile: Synthesize the benefits and risks of the device to demonstrate that the anticipated benefits outweigh the risks. This analysis should be based on data from pre-clinical and clinical studies and should be updated with new information obtained during the investigation.
• Regulatory Compliance: Ensure that the risk management approach complies with ISO 14971, the international standard for the application of risk management to medical devices, and any specific regulatory requirements pertinent to the device.

Continuous Risk Management

• Review and Update: Mechanisms for regularly reviewing and updating the risk management plan as new data become available or as circumstances change during the investigation. This includes planned revisions following interim analyses or in response to external factors such as newly published research or changes in clinical practice.

Risk Management Documentation

• Documentation Standards: Maintain comprehensive documentation of all risk management activities, including assessments, decisions made, actions taken, and the rationale behind each decision. Documentation should be readily accessible and auditable.

This section of the MDR Investigator´s Brochure is essential for ensuring that all potential and actual risks are adequately managed throughout the clinical investigation. The risk management  protects participants and also ensures the integrity of the clinical data and supports the ultimate goal of demonstrating the device’s safety and performance.

4. Regulatory and Compliance Information

Compliance with General Safety and Performance Requirements (GSPRs)

• GSPR Alignment: List and describe how the investigational device complies with each of the applicable General Safety and Performance Requirements as outlined in Annex I of the EU MDR. This includes detailing the device’s design, manufacturing processes, and performance characteristics that ensure compliance.
• Standards and Specifications: Identify all standards and Common Specifications (CS) applied during the device’s development and testing phases, such as ISO standards for medical devices, IEC standards for electrical devices, etc. Provide a justification for each standard’s application and describe how it contributes to the device’s compliance with the GSPRs.

Documentation of Compliance

• Evidence of Compliance: Provide documentation or summaries of test results and analyses that demonstrate the device’s compliance with the aforementioned standards and requirements. This should include both pre-clinical and clinical data, as well as any data related to device modifications.
• Notified Body Interaction: Detail interactions with Notified Bodies, including any conformity assessments or certifications obtained. This section should also cover the scope of the assessments, highlighting critical areas reviewed and any recommendations made by the Notified Body.

Regulatory Submissions and Approvals

• Regulatory Filings: List all regulatory filings made for the device, including submissions to national and international regulatory agencies. Detail the status of these filings, any approvals received, and pending decisions.
• Labeling and Instructions for Use: Ensure that the device’s labeling and instructions for use comply with regulatory requirements. Include information on language requirements, symbols used, and any specific labeling considerations for investigational use.

Compliance with International Guidelines

• ISO 14155 Compliance for Clinical Investigations: Demonstrate how the clinical investigations comply with ISO 14155, which outlines good clinical practice for the design, conduct, recording, and reporting of clinical investigations performed on human subjects. Discuss any deviations from these guidelines and provide justifications.
• Ethical Considerations: Address ethical considerations in compliance with the Declaration of Helsinki and local regulations where the clinical investigations are being conducted. Include information on ethical review board approvals, informed consent processes, and any other ethical safeguards in place.

Continuous Regulatory Monitoring

• Monitoring Changes in Regulations: Establish a process for monitoring and responding to changes in regulatory requirements that could affect the ongoing clinical investigations. This includes updates to laws, guidelines, or standards relevant to the device or its clinical investigation.
• Adaptation to Regulatory Changes: Describe the strategies for adapting the clinical investigation and documentation practices in response to regulatory changes. Ensuring ongoing compliance throughout the investigation’s duration.

This section of the MDR IB serves to assure all stakeholders. Including regulatory authorities, ethics committees, and clinical investigators, that the device meets all necessary safety, performance, and regulatory requirements for clinical investigation. It underscores the sponsor’s commitment to adhering to the highest standards of regulatory compliance and patient safety.

5. MDR Investigator´s Brochure Revisions and Updates

Update Procedures

• Scheduled Updates: Define a schedule for regular reviews and updates of the IB. These should be strategically timed to follow major study milestones, such as the completion of certain phases or after significant data analysis points.
• Trigger Events for Ad-Hoc Updates: Specify conditions or “trigger events” that necessitate immediate updates outside of the regular schedule. These may include significant adverse events, changes in regulatory requirements, or substantial amendments to the clinical investigation protocol.

Document Control and Version Management

• Version Tracking: Implement a version control system to track all changes made to the IB. Each version should be clearly numbered and dated, with a summary of changes provided in each new version.
• Archiving Procedures: Establish procedures for archiving superseded versions of the IB. This ensures that previous versions are accessible for reference or regulatory review, maintaining a complete history of document changes.

Communication of Updates

• Notification System: Develop a systematic approach for notifying all stakeholders, including clinical investigation sites, ethics committees, and regulatory authorities, of updates to the IB. Notifications should detail the nature of the updates and their implications for ongoing clinical activities.
• Training on Updates: Coordinate training sessions for all relevant clinical investigation personnel whenever significant updates are made to the IB. This ensures that all team members are informed about the latest device information, safety protocols, and compliance requirements.

Regulatory Compliance of Updates

• Regulatory Submission of Updated IB: Outline the procedures for submitting updated versions of the IB to regulatory authorities as required by local regulations or international guidelines. Include timelines for submissions following significant changes or discoveries during the investigation.
• Compliance Audits: Regularly audit the update and revision processes to ensure they comply with both internal quality standards and external regulatory requirements. Audits help identify and rectify any discrepancies or inefficiencies in the documentation process.

Feedback Mechanism

• Stakeholder Feedback: Establish a feedback mechanism allowing investigators and other stakeholders to provide input on the IB’s content and layout. This feedback can be instrumental in improving the clarity and utility of the document.
• Continuous Improvement: Use stakeholder feedback and audit outcomes to continually refine the update and revision processes. This ensures that the procedures remain effective and responsive to the needs of the clinical investigation and regulatory landscape.

This section ensures that the MDR IB remains a living document, reflective of the latest scientific knowledge and regulatory standards. By meticulously managing updates, ensuring comprehensive communication and training regarding these changes. Sponsors can maintain the document’s relevance and utility throughout the clinical investigation process.

In summary, the MDR Investigator´s Brochure must be actively managed to remain a current and compliant resource throughout the study. The processes outlined in this section provide a framework for achieving this, ensuring that the MDR IB continuously supports the safe and performance evaluation of the investigational device.

Key Insights

The Role of the MDR Investigator’s Brochure in Medical Device Research

The MDR Investigator’s Brochure is a central document in any clinical investigation for medical devices. Its purpose goes far beyond regulatory compliance. It equips investigators, ethics committees, and regulatory authorities with the information they need to understand the investigational device. With this shared knowledge base, stakeholders can make informed decisions that protect participants and ensure reliable, high‑quality clinical data.

A Dynamic and Evolving Document

The IB is not static. Instead, it must evolve throughout the clinical investigation. As new data, observations, or safety information emerge, sponsors must update the MDR Investigator’s Brochure accordingly. This continuous revision process ensures the document remains accurate, transparent, and aligned with current knowledge. It also reinforces trust among investigators, ethics committees, and regulators.

Integrating Multidisciplinary Expertise

Developing a robust MDR Investigator’s Brochure requires input from multiple disciplines. Engineering, clinical research, regulatory affairs, quality assurance, and risk management all contribute essential insights. This multidisciplinary collaboration ensures the IB is scientifically sound, comprehensive, and reflective of the latest advancements in both medical technology and clinical practice.

Commitment to Transparency and Investigator Education

The MDR Investigator’s Brochure also serves as a critical educational resource. It explains the device’s development history, intended purpose, mechanism of action, and supporting evidence. By presenting this information clearly and objectively, the IB promotes transparency and strengthens the trust of investigators, clinical staff, participants, and the wider public.

Future Considerations

As regulations and standards continue to evolve, the MDR Investigator’s Brochure must adapt. Future developments may include more accessible digital formats, interactive layouts, and harmonized content that supports multinational studies. Proactive updates will be essential as global regulatory expectations shift and clinical research models become more complex.

Conclusion

The MDR Investigator’s Brochure is more than a regulatory requirement—it is a vital tool that shapes the scientific, ethical, and operational quality of clinical investigations. A clear, current, and compliant IB helps sponsors streamline the investigation process, strengthens regulatory confidence, and ultimately supports the development of safe and high‑performing medical devices.

This article has outlined a structured and practical approach to building an Investigator’s Brochure that meets MDR expectations. By following these principles, sponsors can conduct clinical investigations with the highest standards of safety, performance, and data integrity.

Introduction

In the highly regulated and competitive world of medical device development, the choice of a Clinical Research Organization (CRO) is more than a business decision, it’s a strategic partnership crucial to success. A qualified Medical Device CRO brings invaluable expertise in clinical investigations, regulatory navigation, and market entry strategies, acting as a linchpin for the development and approval processes. As the medical device industry grapples with stringent regulations, such as the EU MDR 2017/745, and evolving technological advancements, the stakes for choosing the right Medical Device CRO have never been higher. This article delves into how medical device companies can qualify their CRO partners, ensuring they align with their benchmark of excellence and are fully equipped to navigate the complexities of bringing innovative medical solutions to market.

Qualifying Your Medical Device CRO Partner: A Strategic Evaluation Framework

Choosing the right Clinical Research Organization (CRO) is pivotal for medical device manufacturers seeking to navigate the intricacies of clinical investigations, regulatory compliance, and market success. The process of qualifying a Medical Device CRO goes beyond simple service comparisons; it requires a strategic evaluation framework that ensures the selected partner is not only capable but also highly aligned with the company’s specific needs and goals. This framework should consider a variety of critical factors, including expertise in clinical operations, regulatory acumen, quality assurance capabilities, and a proven track record of success in the medical device field. By adopting a holistic and rigorous approach to evaluating potential CRO partners, companies can foster successful collaborations that are essential for achieving their project milestones and long-term objectives.

Criteria for Excellence: What to Look for in a Medical Device CRO

When selecting a Medical Device Clinical Research Organization (CRO) for medical device development, it’s essential to employ a strategic evaluation framework that encompasses various critical criteria. This rigorous approach ensures that the CRO is not only competent but also perfectly aligned with the specific needs and goals of your project. Here are the key criteria to consider:

1. Expertise in Clinical Operations

Look for a Medical Device CRO with a proven track record in managing and executing clinical investigations specific to medical devices. This includes experience with ISO 14155 and adherence to Good Clinical Practice (GCP), indicating their capability to handle the nuances of medical device clinical investigations.

2. Regulatory Strategy and Compliance

The ideal Medical Device CRO should demonstrate in-depth knowledge of global regulatory requirements, including the EU MDR 2017/745, and FDA regulations. Their expertise should cover strategic planning, submission processes, and the ability to navigate regulatory pathways efficiently.

3. Quality Assurance and Management Systems

Quality assurance is critical in medical device development. The CRO should have robust Quality Management Systems (QMS) in place, compliant with ISO 13485 and capable of ensuring the highest standards are met throughout the project lifecycle.

4. Medical Writing and Documentation

Exceptional medical writing capabilities are essential for clear, compliant, and persuasive documentation. This includes clinical evaluation reports, regulatory submissions, and technical documentation necessary for approval processes.

5. Data Management and Biostatistics

Competence in data management and statistical analysis is vital for interpreting clinical investigation data accurately. The Medical Device CRO should offer sophisticated methods for data collection, management, and analysis, supporting regulatory submissions and market claims.

6. Project Management

Effective project management ensures that clinical investigations are completed on time, within budget, and to the required quality standards. Look for a CRO with a strong project management framework, emphasizing communication, transparency, and stakeholder engagement.

7. Adaptability and Customized Solutions

Each medical device project is unique, requiring tailored approaches. A qualified Medical Device CRO should demonstrate flexibility and the ability to provide customized solutions that align with the specific challenges and goals of your project.

8. Reputation and Track Record

Finally, consider the CRO’s reputation within the industry and its track record of success. Testimonials, case studies, and references from past clients can provide valuable insights into their capabilities and reliability.

By meticulously evaluating potential CRO partners against these criteria, medical device companies can ensure they select a partner that will contribute significantly to the success of their projects.

The right CRO is a crucial ally in the complex journey from concept to market, providing expertise, support, and guidance every step of the way

The Benefits of Partnering with an Excellent Medical Device CRO

Choosing a Clinical Research Organization (CRO) that aligns with the strategic evaluation framework and exemplifies the criteria for excellence, such as MDx, brings manifold benefits to medical device companies. These advantages not only streamline the pathway from development to market but also ensure compliance, enhance quality, and optimize outcomes. Here are the key benefits of such a partnership:

Enhanced Efficiency and Time-to-Market

A CRO that excels in project management, clinical operations, and regulatory strategy can significantly expedite the development process. By effectively navigating clinical investigations and regulatory approvals, an excellent CRO reduces time-to-market, enabling quicker patient access and competitive advantage.

Rigorous Regulatory Compliance and Approval Success

Expertise in global regulatory landscapes is crucial for navigating the complex approval processes. A top-tier CRO ensures that all aspects of the development process, from clinical evaluations to technical documentation, meet the stringent standards set by regulatory bodies. This comprehensive understanding of regulatory requirements minimizes the risk of delays and rejections, facilitating smoother market entry.

Quality Assurance Across the Development Lifecycle

Quality assurance is embedded in the DNA of an excellent Medical Device CRO. Through robust Quality Management Systems (QMS) and adherence to international standards such as ISO 13485, a CRO ensures that every stage of development meets the highest quality standards. This commitment to quality not only supports regulatory compliance but also enhances the safety, efficacy, and reliability of the medical device.

Data Integrity and Scientific Rigor

The management and analysis of clinical investigation data are critical for substantiating claims and supporting regulatory submissions. Partnering with a CRO skilled in data management and biostatistics ensures the integrity and scientific rigor of investigation data, bolstering the case for approval and market acceptance.

Tailored Solutions and Flexibility

Each medical device project comes with its unique challenges and requirements. An excellent Medical Device CRO offers the adaptability and customized solutions necessary to address specific project needs effectively. This flexibility ensures that innovative approaches are applied to overcome obstacles and achieve project goals.

Access to Expertise and Global Networks

A CRO with a wealth of expertise and a global network can provide invaluable resources and insights throughout the development process. From subject matter experts to connections with regulatory bodies and clinical sites, this access facilitates smoother project execution and opens doors to opportunities and collaborations.

Conclusion

In the competitive and highly regulated world of medical device development, partnering with the right Medical Device CRO is not just a choice, it is a strategic imperative. By adhering to a strategic evaluation framework and selecting a CRO that embodies the criteria for excellence, medical device companies can navigate the complexities of development, regulatory approval, and market entry with confidence and efficiency.

MDx serves as a prime example of what to look for in a clinical research partner. With its comprehensive services, unparalleled expertise, and commitment to quality and success, MDx stands ready to support medical device companies in bringing their innovations to market.

For those in the medical device industry seeking a partner that meets these high standards, we invite you to learn more about how MDx can contribute to the success of your projects. Reach out for a consultation or more information on our full-service offerings and take the first step towards realizing your development and market aspirations.

Looking for a qualified medical device CRO?

Frequently Asked Questions about Medical Device CRO

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.

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.

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.

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.

In this article, we will delve into the intricacies of developing a robust Clinical Evaluation Plan using expert regulatory terminology, equipping you with the knowledge to navigate this essential aspect of your MedTech product development.

As the medical device industry evolves and regulatory requirements become more stringent, the need for a well-defined Clinical Evaluation Plan (CEP) has become paramount.

The CEP plays a crucial role in assessing the safety and performance of medical devices, ensuring their compliance with Annex XIV of the Regulation (EU) MDR 2017/745 (MDR), MDCG 2020-6, and MEDDEV 2.7.1. Rev.4.

In this article, we will delve into the intricacies of developing a robust Clinical Evaluation Plan using expert regulatory terminology, equipping you with the knowledge to navigate this essential aspect of your MedTech product development.

1. Clinical evaluation of your medical device

The clinical evaluation of a medical device must be thorough and objective. Manufacturers should consider both favourable and unfavourable clinical data when developing the Clinical Evaluation Plan.

The depth and extent of the clinical evaluation must remain proportionate to the device. This includes its nature, risk class, intended purpose, manufacturer claims, and associated risks.

Manufacturers may base a clinical evaluation on clinical data from an equivalent device when they can demonstrate equivalence. The demonstration of equivalence must cover technical, biological, and clinical characteristics. Notified Bodies strongly recommend claiming equivalence against only one equivalent device.

Under MDR Article 61(1) and Annex XIV, manufacturers must plan, conduct, and document the clinical evaluation. The planning phase must be documented in a Clinical Evaluation Plan. The outcomes of the evaluation and the supporting clinical evidence must then be documented in a Clinical Evaluation Report.

2. What is a Clinical Evaluation Plan?

A Clinical Evaluation Plan (CEP) is a documented strategy that defines a systematic and planned approach to assess the safety and performance of a medical device throughout its lifecycle.

This clinical evaluation plan template provides the framework for collecting, appraising, and analyzing clinical data. Its purpose is to demonstrate conformity with the General Safety and Performance Requirements (GSPRs) set out in Annex I of the MDR.

3. Navigating Annex XIV of MDR 2017/745: Key Requirements

According to Part A, Section 1 of Annex XIV of the MDR, the manufacturer must establish and regularly update the Clinical Evaluation Plan. This ensures that the clinical evaluation remains planned, continuously performed, and properly documented.

Annex XIV defines the minimum requirements that every Clinical Evaluation Plan must address.

Minimum Requirements of a Clinical Evaluation Plan

The CEP must include:

• A clinical development plan outlining the progression from exploratory investigations to confirmatory clinical investigations and PMCF activities, including milestones and acceptance criteria.
• Identification of GSPRs that require support from relevant clinical data.
• Specification of the intended purpose of the device.
• Clear definition of target groups, including indications and contraindications.
• Description of intended clinical benefits with defined clinical outcome parameters.
• Methods for evaluating qualitative and quantitative aspects of clinical safety, including residual risks and side effects.
• Parameters used to assess the acceptability of the benefit-risk ratio based on the current State of the Art.
• An explanation of how benefit-risk issues related to specific components, such as medicinal substances or animal or human tissues, are addressed.

3.1. Clinical Data from Systematic Scientific Literature Reviews

Manufacturers should conduct a systematic scientific literature review to identify relevant clinical data for the device and its intended purpose.

The review should also identify gaps in the available clinical evidence. This supports a complete and transparent understanding of the existing data landscape.

Using structured methodologies such as PRISMA and PICO is recommended, as these approaches improve the systematic nature and reproducibility of the literature search.

3.2. Clinical Data from Clinical Investigations

Manufacturers should design and conduct clinical investigations in line with the Clinical Development Plan.

These investigations should generate new or additional clinical data when existing evidence does not sufficiently demonstrate safety and performance. The generated data should directly support the objectives of the Clinical Evaluation Plan.

3.3. Clinical Data Appraisal and Suitability

Manufacturers must appraise all relevant clinical data to determine their suitability for demonstrating device safety and performance.

This appraisal should consider data quality, reliability, and relevance. It should also follow the hierarchy of clinical evidence described in Appendix III of MDCG 2020-6 when assessing conformity with MDR GSPRs.

3.4. Clinical Data Analysis and Conclusions

Manufacturers must analyze all relevant clinical data, including literature data, existing clinical studies, and newly generated clinical investigation data.

The analysis should support clear conclusions on safety, clinical performance, and clinical benefits. This process includes data interpretation, statistical analysis, and benefit-risk assessment. The outcome must support robust, evidence-based conclusions within the Clinical Evaluation Plan.

4. Navigating MDCG 2020-6: Key Considerations for Your Clinical Evaluation Plan

The MDCG 2020-6 guidance, “Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC”, provides detailed direction on how to perform a clinical evaluation under the MDR. It supports both manufacturers and Notified Bodies in assessing clinical evidence for legacy medical devices.

This guidance is particularly relevant when preparing a clinical evaluation plan template that complies with MDR requirements.

4.1. Clinical Evaluation Plan Documentation Requirements

MDCG 2020-6 confirms that manufacturers must document a Clinical Evaluation Plan in accordance with MDR Annex XIV. The guidance also provides practical recommendations to support compliance with Annex XIV, Section 1(a).

A compliant Clinical Evaluation Plan should include:

• Identification of the applicable General Safety and Performance Requirements (GSPRs).
• A clear definition of the intended purpose, target patient groups, indications, and contraindications.
• A detailed description of the intended clinical benefits, supported by defined clinical outcome parameters.
• Specification of qualitative and quantitative aspects of clinical safety and clinical performance.

4.2. Sources of Clinical Data

According to MDCG 2020-6, the Clinical Evaluation Plan must clearly identify all relevant sources of clinical data. These sources may include pre-market, post-market, and newly generated clinical data.

Pre-market clinical data may consist of:

• Clinical investigation reports for the device under evaluation.
• Clinical investigations or studies published in scientific literature for equivalent devices.
• Peer-reviewed literature reporting other clinical experience with the device or an equivalent device.
• Additional pre-market data, such as case reports related to device use.

Post-market clinical data may include:

• Post-Market Surveillance (PMS) clinical data.
• Complaint handling and vigilance reports.
• Post-Market Clinical Follow-up (PMCF) studies and investigations.
• Independent clinical studies, device registries, and relevant literature data.

Newly generated clinical data should also be included when available and justified.

The Clinical Evaluation Plan must also describe the system used to appraise and analyze all clinical data sources.

4.3. Minimum Content of a Clinical Evaluation Plan for Legacy Devices

Appendix II of MDCG 2020-6 defines the minimum content required for a Clinical Evaluation Plan for legacy devices. This minimum content includes:

• Identification of GSPRs that require support from clinical data.
• Specification of the intended purpose of the device.
• Clear definition of target groups, including indications and contraindications.
• Description of intended clinical benefits with defined clinical outcome parameters.
• A strategy to identify, analyze, and assess alternative treatment options.
• Methods for evaluating qualitative and quantitative aspects of clinical safety, including residual risks and side effects.
• Defined parameters to assess the acceptability of the benefit-risk ratio based on the current State of the Art.
• An explanation of how benefit-risk issues related to specific components, such as medicinal substances or animal or human tissues, are addressed.
• A strategy and methodology to identify, analyze, and appraise all relevant clinical data under the MDR definition of clinical data.
• Evidence supporting equivalence when clinical data from an equivalent device is used.
• A justification of the required level of clinical evidence based on device characteristics and intended purpose.
• A strategy for the systematic collection, analysis, and assessment of post-market surveillance data to demonstrate continued safety and performance of legacy devices.

4.4. Hierarchy of Clinical Evidence Under MDCG 2020-6

Appendix III of MDCG 2020-6 introduces a hierarchy of clinical evidence to support conformity with MDR GSPRs. This hierarchy ranks different types of clinical data from strongest to weakest.

Manufacturers should consider this hierarchy when defining the appraisal methodology in their clinical evaluation plan template. Applying the suggested hierarchy supports a robust and transparent assessment of clinical evidence and strengthens the overall Clinical Evaluation Plan.

5. Navigating MEDDEV 2.7.1. Rev.4: What To Consider?

MEDDEV 2.7.1. Rev.4 refers to the fourth revised version of the Medical Device Vigilance Guidance Document.

This document encourages the adoption of a standardized approach to clinical evaluation for medical devices that fall under the regulation of directives 90/385/EEC and 93/42/EEC.

MEDDEV 2.7.1 Rev.4 continues to be used even after the implementation of MDR since it offers additional interpretive guidance and practical recommendations that complement the MDR requirements.

Section 7 of MEDDEV 2.7/1 rev. 4 addresses the definition of scope of the clinical evaluation, which constitutes the Stage 0 of a clinical evaluation, and, according to MDR and MDCG 2020-6, states that the manufacturer should set up a Clinical Evaluation Plan for the device under evaluation. 

Recognizing the wide range of technologies employed in medical devices, along with their diverse histories and associated risks, is crucial.

Therefore, Section 7 of MEDDEV 2.7/1 rev. 4 also examines the different aspects to be considered for setting up a CEP depending on the stage in the lifecycle of the product and its regulatory status (i.e., before CE-marking, For CE-marked devices).

Moreover, Appendix A3 of MEDDEV 2.7/1 rev. 4 lists information that can be relevant for planning clinical evaluations. It is paramount that the manufacturer ensures that input for the Clinical Evaluation Plan shows alignment with the device’s “label, instructions for use, promotional or sales materials or statements” and with the device’s updated risk management documentation.

Must have considerations for your Clinical Evaluation Plan Template MDR-based

At MDx CRO, we recognize the significance of a well-structured Clinical Evaluation Plan (CEP) in ensuring the safety and performance of medical devices.

The design of a Clinical Evaluation Plan (CEP) template according to the Medical Device Regulation (MDR) 2017/745 should be tailored to the specific typology of the manufacturer’s device.

This customization is critical as every medical device has unique attributes, different indications for use, target populations, and risk profiles.

Therefore, the use of a generic template for all devices is not recommended. Although it might be tempting to use a “one-size-fits-all” approach for efficiency reasons, such practice could overlook the MDR’s specific requirements for each individual device, potentially leading to non-compliance with established safety and efficacy standards.

Additionally, lack of specificity could lead to erroneous or inappropriate conclusions in the clinical evaluation, jeopardizing the device’s approval for marketing. In summary, it is essential that each Clinical Evaluation Plan is designed and tailored specifically for the device being evaluated, in line with the guidelines of the MDR 2017/745.

Despite the unique considerations required for each device’s Clinical Evaluation Plan (CEP) under the MDR 2017/745, we understand the value of having a general framework to start from. Therefore, we will provide a template that serves as a starting point for the development of a Clinical Evaluation Plan.

This template will include essential elements required under the MDR 2017/745 such as:

• Plan rationale
• Device description
• Clinical background
• Identification of pertinent data sources
• Clinical evaluation method
• Plan for the appraisal of clinical data.

Remember, this is a guide to help initiate the process and not a final document. You will need to tailor the template to fit your specific device, its indications, target population, risk factors, and other device-specific attributes.

Our intention is to help streamline the process, providing structure while also emphasizing the importance of customization to meet the regulatory requirements.

Clinical Evaluation Plan Template Guidance

To streamline the development process and support compliance with regulatory requirements, this clinical evaluation plan template outlines the recommended structure and content of a Clinical Evaluation Plan (CEP). It helps manufacturers document clinical evidence in line with applicable regulations and guidance.

• SECTION 1. SUMMARY
• SECTION 2. REFERENCES
• SECTION 3. ACRONYMS AND DEFINITIONS
• SECTION 4. RESPONSIBILITIES
• SECTION 5. SCOPE OF THE CLINICAL PLAN AS PART OF THE CLINICAL EVALUATION

This section defines the scope of the Clinical Evaluation Plan within the overall clinical evaluation process. It addresses the applicable General Safety and Performance Requirements (GSPR). It also references previous clinical evaluations and the current CEP.

The section explains any deviations from the CEP and justifies them when needed. In addition, it covers the Instructions for Use (IFU), device labeling, and related risk management activities.

SECTION 6. DEVICE DESCRIPTION

This section provides a clear and structured description of the medical device. It includes the device name, classification, and a brief technical overview. It also lists device components, materials, sizes, and available models.

The manufacturer name, generic device group, and device lifecycle stage must be stated. The section also explains the intended purpose of the device and how it achieves that purpose.

In addition, it defines the clinical condition, target patient population, and target user group. Contraindications, warnings, cautions, precautions, and known undesirable effects are documented to support the clinical evaluation.

SECTION 7. CLINICAL BACKGROUND AND STATE OF THE ART

This section describes the clinical background relevant to the device. It identifies the sources used for the clinical evaluation, including applicable standards and guidance documents.

The State of the Art analysis outlines current medical knowledge. It includes benchmark devices and other available treatment options. This comparison supports the assessment of safety and performance.

SECTION 8. EVALUATION OF THE DEVICE

This section explains the type of clinical evaluation performed. It defines the safety and performance parameters assessed during the evaluation process.

When applicable, the section describes how device equivalence is demonstrated. It also identifies the sources of clinical data. These sources may include manufacturer-generated data, data from systematic literature reviews, and post-market surveillance or vigilance activities.

SECTION 9. ANALYSIS OF CLINICAL DATA

This section outlines the methods used to analyze clinical data. It evaluates safety in accordance with GSPR 1 to 8 and performance in line with GSPR 1.

The section also assesses the benefit-risk profile and the acceptability of undesirable side effects, as required by GSPR 8. Any additional clinical claims are reviewed and supported with appropriate evidence.

SECTION 10. CLINICAL DEVELOPMENT PLAN

SECTION 11. ADDITIONAL ITEMS FROM APPENDIX II OF MDCG 2020-6 (LEGACY DEVICE)

This section describes planned or ongoing pre-market and Post-Market Clinical Follow-up (PMCF) investigations, when applicable. It explains how these activities support the clinical evaluation over the device lifecycle.

SECTION 12. PMS AND PMCF PLANS
SECTION 13. FREQUENCY OF CLINICAL EVALUATION UPDATES
SECTION 14. DATES AND SIGNATURES
SECTION 15. ANNEXES

This clinical evaluation plan template provides a structured guide to the essential elements of a CEP. It supports consistent documentation of device description, clinical data requirements, benefit-risk analysis, and post-market clinical follow-up activities.

Why use this Clinical Evaluation Plan Template?

This clinical evaluation plan template provides a structured and practical framework for preparing a compliant CEP. It supports consistent documentation of device description, clinical data requirements, benefit-risk analysis, and post-market clinical follow-up activities. As a result, it helps manufacturers meet regulatory expectations and maintain clinical evidence throughout the device lifecycle.

If you need help preparing your clinical evaluation plan template or developing a compliant Clinical Evaluation Plan, contact us to discuss your project and regulatory needs.