Medical Device Clinical Evaluation and European Regulatory Framework

Demonstrating the safety and effectiveness of medical devices under EU MDR requires precise clinical evaluation. At I3CGLOBAL, we help medical device manufacturers prepare and submit robust documents to Notified Bodies by conducting systematic literature reviews, analysing clinical data, and planning clinical investigations as needed.

Our expert team ensures that all clinical evaluation documentation meets MDR Article 61 and MEDDEV 2.7/1 requirements, streamlining Notified Body submissions. By partnering with us, you gain reliable guidance and well-prepared documents and reports to ensure the clinical safety of your devices, backed by high-quality clinical evidence, reducing risks, and accelerating your path to the European medical device market

Not all medical devices require new clinical investigations, but under EU MDR, they become necessary when existing clinical data is insufficient or unavailable to fully demonstrate the safety and performance of the device. Clinical investigations are particularly required for:

• High-risk (Class IIb and III) devices where robust clinical evidence is critical.
• Novel or innovative devices with no equivalent device on the market.
• Devices with new intended uses or significant modifications compared to previous versions.
• Devices with limited post-market clinical data that cannot fully support claims of safety and performance.

Even when clinical investigation are not strictly required, manufacturers must still conduct a systematic clinical evaluation using existing literature, post-market data, and equivalent device information. This ensures that all devices, regardless of risk class, meet MDR Article 61 requirements and maintain patient safety.

By carefully assessing the need for clinical investigation, manufacturers can optimize regulatory compliance, avoid unnecessary studies, and ensure that their Clinical documentation is comprehensive and credible.

Clinical evaluation of medical devices is a key component of the EU MDR 2017/745 technical documentation. It is required for several reasons:

• It determines the scientific validity of the device by examining clinical data from multiple sources, such as clinical investigations, published literature, post-market surveillance, and post market clinical follow up. This ensures that the device’s safety, performance, and clinical benefit claims are supported by solid, documented evidence.
• Clinical evaluation and risk management are closely interrelated. Risk management identifies, evaluates, and mitigates potential risks, while evaluation helps estimate the device’s risk benefit profile, guiding decisions on patient safety and risk management strategies.
• MDR Article 61 emphasizes ongoing evaluation through post-market surveillance (PMS) and Post-Market Clinical Follow-up (PMCF). Continuous monitoring identifies new risks and ensures that the device remains safe and effective throughout its lifecycle.
• The evaluation must demonstrate that the device is safe and effective for the intended user population and clinical indications, reducing the likelihood of adverse events or ineffective treatment in real-world use.
• It must provide a detailed justification of equivalence/similarity, comparing the technical, biological, and clinical characteristics of equivalent devices. This ensures that clinical data from equivalent devices can be reliably applied.
• The findings guide decisions on device labeling, instructions for use, contraindications, and precautions, and help Notified Bodies assess whether the device should be approved for market entry or continued use.
• A well-conducted evaluation enhances transparency, giving healthcare professionals, patients, and Notified Bodies confidence in the device’s performance and safety.

At I3CGLOBAL, our team of doctors, dentists, nurses, regulatory professionals, and CER writers provides end-to-end solutions for medical device manufacturers of all sizes interested in MDR CE Mark certification. We ensure compliance with MDR Article 61 and MEDDEV 2.7/1 Rev. 4, helping your documentation meet the expectations of different Notified Bodies.

The clinical evaluation process is a systematic and ongoing assessment of clinical data to verify the safety and performance of a medical device throughout its lifecycle. Below is an overview of the key steps involved:

• Review EU MDR 2017/745 Article 61 and the MEDDEV 2.7/1 Rev. 4 guidance document, which define the requirements for conducting a clinical evaluation.
• Identify a qualified clinical evaluator with appropriate training and experience related to the device under evaluation.
• Analyse preclinical testing data to assess performance and safety against benchmark values.
• Clinical Evaluation documentation must demonstrate the state of the art through a thorough analysis of technologies, parameters, and comparable devices available globally.
• Devices with the same intended use, technological characteristics, and biological properties may be considered equivalent devices for data comparison.
• Scientific literature serves as a permanent record of research findings and is a key source for collecting clinical data and supporting evidence.
• Clinical data should include information on safety, performance, and side effects from human clinical studies or equivalent technologies, as applicable.
• The technical documentation, including the CER, must align with MDR 2017/745 requirements and support the device’s conformity assessment process.
• Post-market surveillance activities generate real-world clinical data that help identify rare or previously unknown events, ensuring continued device safety and effectiveness.

MEDDEV 2.7/1 Rev. 4 provides manufacturers with guidance to perform a robust and systematic clinical documentation and demonstrate the scientific validity of data and conclusions. Key updates in Rev. 4 include:

• Clause 6.2.3 specifies how often the Clinical report should be reviewed and updated
• Clause 6.4 details about qualification of evaluators or authors which ensures clinical evaluators have the necessary expertise
• Clinical documentation must address safety, performance, and risk-benefit endpoints which are detailed in section 7 & Appendix 5
• Clause 8.2, establishing the State of the Art defines how to compare the device with current standards and practices
• Sections 8, 9, 10 & Appendices 5–7, guidelines for assessing clinical data reliability and relevance (Scientific validity of datasets)
• Appendix 1, detailed instructions for justifying similarity with equivalent devices
• When clinical investigations are required Appendix helps manufacturers identify situations needing new clinical studies
• Risk-benefit assessment mentioned in appendix 7.2, provides additional guidance on evaluating potential risks versus clinical benefits
• Reinforced PMS and PMCF integration which strengthens post market surveillance and follow up requirements
• Notified Bodies’ role and actions in Appendix 12 clarifies expectations for regulatory review and assessment