Clinical evaluations are often the most challenging part of technical documentation, yet they are crucial for demonstrating that safety and performance requirements have been met. They also play a key role in broader market access considerations, such as health technology assessments (HTAs) and effectively communicating value propositions to payers and customers.
This article unpacks clinical evaluations, why they matter, and how to conduct them in compliance with global regulations. It focuses on the EU Medical Device Regulation (EU MDR) and provides insights into the US FDA and other international requirements.
What is a clinical evaluation?
A clinical evaluation is a systematic and planned process for continuously generating, collecting, analysing, and assessing clinical data related to a medical device. Its purpose is to demonstrate that a device achieves its intended purpose without exposing users or patients to unnecessary risks. It culminates in a Clinical Evaluation Report (CER), a key part of the technical documentation.
Clinical evaluation is essential for:
- Supporting conformity assessment under CE marking in Europe
- Demonstrating substantial equivalence in FDA submissions
- Meeting post-market surveillance obligations
- Informing healthcare professionals, regulators, payers and patients
What is the difference between clinical evaluation vs. clinical investigation?
It’s important to distinguish between the two:
- Clinical Evaluation: A desk-based systematic review and synthesis of existing clinical literature, post-market data, and/or clinical investigations to demonstrate that a product achieves its intended purpose without exposing patients or users to unacceptable risks.
- Clinical Investigation (Clinical Trial): Studies involving human subjects are required when existing data are insufficient to determine efficacy or safety. High standards must be met for conducting medical device clinical investigations, following Good Clinical Practice (ISO 14155) and approval by ethics committees and competent authorities.
When is a clinical evaluation required?
The term “clinical evaluation” is most prominently and formally defined in the context of the EU Medical Device Regulation (MDR) and in vitro Diagnostic Regulation (IVDR). Under the MDR/IVDR, clinical evaluation is required:
- Before placing a device on the market, for CE marking.
- When changes are made to the device’s design, indications, or intended use.
- Post-market, as part of surveillance and vigilance activities required throughout the product’s lifecycle.
It’s a common misconception that clinical evaluations are specific to European conformity assessments. However, the concept—evaluating clinical evidence to demonstrate the safety and effectiveness of a medical device—is not exclusive to the MDR/IVDR. Other regulatory systems use similar processes, but may use different terms:
- In the U.S., the FDA refers to similar activities in the context of clinical evidence, clinical performance, or clinical studies within a Premarket Notification (510(k)), PMA, or De Novo submission.
- In Australia, the TGA uses the term clinical evidence to encompass what the MDR calls a clinical evaluation.
- Internationally, the International Medical Device Regulators Forum (IMDRF) provide guidance on clinical evaluations.
So while “clinical evaluation” as a formal regulatory term is specific to the EU MDR/IVDR, the underlying concept is global, and similar processes exist under other names in most regulatory frameworks.
Role of equivalence in clinical evaluation
Equivalence refers to the demonstration that another medical device has similar clinical, technical, and biological characteristics to the device under evaluation. This allows its clinical data to be used to support safety and performance claims.
Equivalence plays an important but distinct role in clinical evaluations under the EU MDR/IVDR and the U.S. FDA regulatory frameworks. While both systems allow leveraging existing data from similar or predicate devices, the rationale, use, and regulatory expectations differ.
Under the EU MDR and IVDR, clinical evaluations must demonstrate that a device achieves its intended purpose without compromising safety. When manufacturers do not generate new clinical data, they can rely on clinical data from an equivalent device, but only under strict conditions. This allows manufacturers to use data from an already-marketed equivalent device, saving time and cost and avoiding redundant trials. If the data used in the clinical evaluation is from another device, the manufacturer must justify equivalence in:
- Clinical characteristics (e.g., patient population, indications)
- Technical characteristics (e.g., design, materials, specifications)
- Biological characteristics (e.g., interaction with tissues or fluids)
Equivalence must be thoroughly documented and traceable in the Clinical Evaluation Report (CER), the Clinical Evaluation Plan (CEP), and the technical documentation.
Under MDR, equivalence is much harder to claim than under the older MDD. Access to technical and clinical data is typically required if the equivalent device is not yours.
In the U.S., equivalence is primarily used in the 510(k) pathway, where a manufacturer must show that the new device is substantially equivalent to a legally marketed predicate device. Demonstrating substantial equivalence (in intended use and technological characteristics) allows a device to be cleared without extensive new clinical data. Like in the EU, it avoids unnecessary clinical trials if the new device doesn’t pose new or increased risks compared to the predicate.
Substantial equivalence helps FDA determine if general and special controls are sufficient to ensure safety and effectiveness. In 510(k)s, manufacturers must submit a detailed comparison with the predicate, showing how differences do not raise new safety/effectiveness concerns.
How to conduct a clinical evaluation
As with many medical device innovation activities, the clinical evaluation process is risk-based and iterative. The goal is to gather and analyse existing clinical data relevant to the performance and safety of the device under investigation (DUI) and other similar devices (predicate or equivalent products).
The following is a standardised approach following four main stages outlined in MEDDEV 2.7/1 Rev. 4 (the current de facto guidance for conducting CERs for EU MDR/IVDR submissions):
Define the purpose, intended use, target populations, and clinical claims. Develop a Clinical Evaluation Plan (CEP) that provides a structured, proactive framework for how clinical data will be identified, collected, appraised, and analysed to demonstrate that a medical device meets relevant safety and performance requirements.
Competent authorities and notified bodies expect a clearly defined CEP as part of the technical documentation. It helps demonstrate that the clinical evaluation follows a systematic and methodologically sound process aligned with MEDDEV 2.7/1 Rev. 4 and the MDR/IVDR.
- Avoiding bias and ensuring scientific rigour: By planning and documenting a protocol in advance, manufacturers reduce the risk of introducing bias, such as selectively including only favourable data or interpreting results subjectively. A predefined plan ensures that inclusion/exclusion criteria, literature search strategies, appraisal methods, and endpoints are determined before any data is reviewed, strengthening the evaluation’s credibility and transparency.
- Efficient resource allocation: Having a plan prevents duplication of effort and helps allocate resources effectively. It defines responsibilities, timelines, and data sources, reducing unnecessary delays or scope creep. A robust CEP ensures that relevant clinical evidence is generated not just for regulatory approval but also to support reimbursement, health technology assessments (HTAs), and value-based communication with payers and providers.
- Lifecycle management: The CEP outlines how clinical data will be updated over time, which is vital for post-market surveillance and maintaining device conformity throughout its lifecycle.
Search for existing clinical data from:
- Clinical investigations (pre- and post-market)
- Published scientific literature
- PMS/PMCF reports
- Registries or real-world evidence
The device’s intended purpose provides context, helping to define clear research questions. These questions should be structured using validated formats like PICO (Population, Intervention, Comparator, Outcome).
Literature searches should follow a validated, pre-specified plan that considers all relevant factors, ensures reproducibility, and minimises bias and the risk of omitting important sources. Data sources should use at least two databases and be defined in advance to reduce selection bias. Inclusion and exclusion criteria must be justified and defined before the searches are performed. A process must be in place to detect and manage duplicate data and determine whether systematic reviews are excluded. Overall, the goal is a transparent, well-justified, and reproducible approach.
Evaluate the scientific validity, relevance, and robustness of the data. No universally defined appraisal system exists, so the chosen approach must be justified based on multiple factors. Appraisal aims to assign a score to each study, allowing evidence to be weighted according to its quality.
Key appraisal criteria include study type and design, sample size, statistical methods, follow-up duration, and relevance to the device under evaluation. Bias, confounding, peer review, and publication status are also relevant.
Since studies may vary in strength across these areas, an overall appraisal score should reflect this balance. It can be used as a weighting factor to adjust the study’s contribution to the clinical evaluation.
Aggregate the findings to assess:
- Clinical performance: Does the device achieve its intended purpose?
- Clinical safety: Are the risks acceptable compared to the benefits?
- Benefit-risk ratio: Is it favourable and justified?
Safety and performance objectives for a medical device should be assessed against predefined acceptance criteria to ensure the device meets its intended purpose. These criteria are typically based on clinical data, risk management, and regulatory expectations. If the device’s outcomes are shown to be non-inferior to the state-of-the-art—meaning they are at least as safe and effective as existing, comparable devices—this is generally considered acceptable from a regulatory and clinical perspective.
Compile the findings into a CER that documents the evaluation process, conclusions, and justification for conformity.
Here are a few tips for writing a high-quality Clinical Evaluation Report (CER):
- Organise for clarity and navigation: Structure your CER clearly with well-labelled sections, subheadings, and a logical flow. Use tables, summaries, and cross-references to help reviewers easily locate key information. A clear structure reduces review time and improves the perceived quality of the documentation.
- Ensure traceability: Cross-reference your CER with related technical documentation, especially risk management files, post-market surveillance plans, and labelling. This demonstrates consistency and supports traceability. Justify every decision: Record the rationale and supporting evidence for every conclusion, such as the relevance of literature, inclusion/exclusion of studies, or equivalence claims. Transparency is critical: Regulators expect to see how and why each judgment was made.
- Maintain a neutral tone: Avoid language that reflects bias toward positive or negative outcomes. Use neutral phrasing, even when interpreting favourable findings, and acknowledge study limitations or adverse outcomes where appropriate. Your goal is to present a balanced, evidence-based evaluation.
By following these tips, you’ll help ensure your CER is both regulator-ready and scientifically sound.
Global clinical evaluation requirements
The EU MDR is currently the most rigid and data-intensive regulatory framework for clinical evaluation, particularly for high-risk medical devices. The UK remains largely aligned with the legacy EU Medical Device Directive (MDD) but is diverging and developing its independent regulatory framework. The US FDA offers a dual-track approach: the 510(k) pathway allows for clearance based on substantial equivalence with minimal clinical data. In contrast, the PMA pathway requires extensive clinical evidence for approval. Australia and Canada strike a balance between structured regulatory expectations and flexibility, often accepting literature and overseas data with appropriate justification.
| Feature / Jurisdiction | EU MDR (Reg. EU 2017/745) | US FDA (21 CFR Parts 812, 814)** | Australia (TGA) | Canada (Health Canada) | UK (MHRA – UK MDR 2002) |
|---|---|---|---|---|---|
| Foundational Guidance | Annex XIV + MDCG guidance | FDA Guidance (Benefit-Risk, IDEs, PMA, 510(k) Substantial Equivalence) | Australian Regulatory Guidelines for Medical Devices (ARGMD) | Medical Devices Regulations (SOR/98-282) + HC Guidance | UK MDR 2002 + MHRA guidance suite |
| Core Requirement | Mandatory for all classes (I–III/IV) | Required if no predicate (PMA); less so for 510(k) | Required for all classes; risk-based | Required for Class II–IV | Required for Class IIa–III |
| Accepted Sources | Clinical studies, literature, PMS, PMCF | Pivotal studies, bench, animal, literature, real-world data | Clinical studies, literature, overseas approvals | Device-specific studies, literature, and post-market data | Clinical studies, literature, and real-world data |
| Equivalence Allowed? | Yes, but tightly controlled | Yes under 510(k) via substantial equivalence | Yes with strong rationale | Yes with justification | Yes with strong rationale |
| Literature Reviews | Must be systematic (e.g. MEDDEV 2.7/1) | Accepted if high quality; must support indication | Systematic and justified | Systematic, inclusion/exclusion documented | Systematic and well-documented |
| Post-Market Clinical Follow-up (PMCF) | Mandatory unless justified | Postmarket studies often required (especially under PMA or as conditions of clearance) | PMS required; PMCF by risk | Post-market safety and effectiveness required | Post-market review of vigilance data; PMCF if risk warrants |
| Clinical Investigations | Required if no equivalence or robust data | IDE required for significant risk devices; GCP per 21 CFR 812 | Requires TGA notification; ISO 14155 compliance | Investigational Testing Authorization (ITA) + REB | MHRA notification; ISO 14155 required |
| Regulator Involvement | Notified Body evaluates evidence | FDA reviews directly (esp. PMA); advisory panels for high-risk | TGA reviews high-risk devices; evidence reviewed during conformity assessment | Health Canada reviews Class III/IV devices | MHRA reviews higher-class devices post-Brexit |
| Alignment with EU MDR | — | Partial alignment; different terminology and risk classification | Substantial alignment with EU MDR | Moderate alignment; pragmatic on equivalence | Based on EU MDD, diverging post-Brexit |
Clinical evaluations supporting HTAs and reimbursement
Clinical evidence synthesis is not just a regulatory requirement. Systematic literature reviews (SLRs) and clinical evaluations support Health Technology Assessments (HTAs) and payer submissions by demonstrating comparative benefits over existing standards of care, informing cost-effectiveness analyses, and reducing uncertainty in decision-making. Synthesising high-quality published data strengthens the clinical evidence base needed for reimbursement approval, especially when real-world or head-to-head trial data are limited.
The analysis required for HTA and payer submissions differs from that for regulatory submissions in both purpose and focus, even though both rely on clinical evidence.
Purpose: To demonstrate safety, performance, and, in some cases, clinical benefit to secure market authorization.
Focus:
- Device performance under controlled conditions.
- Compliance with Essential Principles or General Safety and Performance Requirements.
- Clinical data may come from bench tests, clinical investigations, or literature.
Acceptable Evidence: May include single-arm studies, bench testing, literature equivalence, especially for lower-risk devices.
Comparators: Not always required; focus is on the device’s performance in isolation or vs. predicate (e.g., in 510(k) pathway).
Purpose: To evaluate clinical effectiveness and cost-effectiveness for reimbursement or coverage decisions.
Focus:
- Comparative effectiveness vs. current standard of care.
- Real-world outcomes and value for money.
- Often includes quality of life data and resource utilisation.
Acceptable Evidence: Preference for randomised controlled trials (RCTs) and systematic literature reviews; real-world evidence and health economics are key.
Comparators: Critical—must compare the new device to the current treatment or practice.
Conclusion
Clinical evaluations are no longer just a checkbox exercise—they are foundational to demonstrating the safety and performance of medical devices across their lifecycle. With evolving global regulations, especially the stringent requirements under EU MDR, manufacturers must treat clinical evaluation as a living process.
A well-executed clinical evaluation does more than satisfy regulators: it builds clinical credibility, improves patient outcomes, and supports commercial success. Companies can confidently navigate this complex area by embracing structured methodologies, aligning with current regulatory guidance, and investing in high-quality evidence.
Resources
This section contains the guidelines on clinical evaluation provided by regulatory authorities. Some of these documents also contain guidance relevant to clinical investigations.
European Union (EU): Medical Device Coordination Group (MDCG)
- MEDDEV 2.7/1 Rev. 4 Guidelines on Clinical Evaluation
- MDCG 2020-1 – Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software (Mar 2020)
- MDCG 2020-5 – Guidance on clinical evaluation – Equivalence (Apr 2020)
- MDCG 2020-6 – Guidance on sufficient clinical evidence for legacy devices (Apr 2020)
- MDCG 2020-13 – Clinical evaluation assessment report template (Jul 2020)
- MDCG 2019-9 rev.1 – Summary of safety and clinical performance (Mar 2022)
- MDCG 2024-10 – Clinical evaluation of orphan medical devices (2024)
- MDCG 2024-5 – Guidance on content of the Investigator’s Brochure for clinical investigations of medical devices (Apr 2024)
- MDCG 2024-3 – Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices (Mar 2024)
United States of America (USA): Food and Drug Administration (FDA)
- FDA Guidance on Clinical Evidence
- Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions (Docket Number: FDA‑2017‑D‑5298)
- Evaluation of Sex-Specific Data in Medical Device Clinical Studies (Docket Number: FDA‑2011‑D‑0817)
- Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies (Docket Number: FDA‑2016‑D‑0734)
- Design Considerations for Pivotal Clinical Investigations for Medical Devices
- FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations
- Software as a Medical Device (SaMD): Clinical Evaluation (Docket Number: FDA‑2016‑D‑2483)
- Medical Devices with Indications Associated with Weight Loss – Clinical Study and Benefit‑Risk Considerations (Draft)
Canada: Health Canada
- Guidance on Clinical Evidence Requirements for Medical Devices
- Examples of Clinical Evidence Requirements for Medical Devices
- Guidance on Supporting Evidence for New and Amended Licence Applications (Class III & IV Devices, non-IVDDs)
- Guidance for the Interpretation of Significant Change of a Medical Device
- Applications for Medical Device Investigational Testing Authorizations Guidance
United Kingdom (U.K.): Medicines and Healthcare products Regulatory Agency (MHRA)
- Clinical investigations for medical devices
- Guidance for manufacturers on compiling a submission to MHRA
- Clinical investigations of medical devices – guidance for investigators
- Clinical investigations of medical devices – biological safety assessment
- Statistical considerations for clinical investigations of medical devices
- In vitro diagnostic medical devices: guidance on legislation
Australia: Therapeutic Goods Administration (TGA)
- Clinical Evidence Guidelines for Medical Devices (V3.2)
- Clinical Evidence Guidelines: Medical Devices (V3.1)
- Clinical Evidence Guidelines Supplement: In Vitro Diagnostic (IVD) Medical Devices (V1.0)
- Meeting Clinical Evidence Requirements for In‑Vitro Diagnostic (IVD) Medical Devices
- Understanding Evidence Requirements for Market Authorisation of Medical Devices
- Providing Documentation for Inclusion of Medical Devices in the ARTG
- Demonstrating Evidence to Comply with the Essential Principles
International Medical Device Regulators Forum (IMDRF)
- IMDRF Clinical Evaluation Guidance
- Clinical Evidence – Key Definitions and Concepts (IMDRF/GRRP WG/N65FINAL:2021)
- Essential Principles of Safety and Performance of Medical Devices and IVDs (IMDRF/GRRP WG/N47FINAL:2018)
- Clinical Performance Studies for IVD Medical Devices (IMDRF/IVD WG/N63FINAL:2019)
Guidelines on Gathering Clinical Evidence from Payers & HTA Organisations
- NICE (UK) – Medical Technologies Evaluation Programme. Guidance on clinical and cost-effectiveness evidence required for NHS coverage. Emphasises real-world data and comparative effectiveness.
- CADTH (Canada) – Health Technology Assessment. Offers guidance on clinical and economic evidence for reimbursement decisions. Focuses on systematic reviews, clinical trials, and real-world evidence.
- IQWiG (Germany) – Institute for Quality and Efficiency in Health Care. Defines standards for clinical evidence including comparative clinical trials and patient-relevant outcomes.
- PBAC (Australia) – Pharmaceutical Benefits Advisory Committee. Provides criteria and methods for clinical evidence evaluation to support reimbursement listing.
- EUnetHTA (Europe) – European Network for Health Technology Assessment. Issues methodological guidelines for clinical effectiveness and safety assessments across European HTA bodies.
- CMS (USA) – Centres for Medicare & Medicaid Services. Provides evidence guidelines for coverage determination including clinical trial data and real-world evidence.
European Union (EU):
Medical Devices Regulation (MDR) 2017/745:
- Clinical Evaluation: Chapter VI, Article 61: Clinical Evaluation (1)
- ANNEX XIV: Clinical evaluation and post-market clinical follow-up
United States of America (USA):
Food and Drug Administration (FDA), Federal Food, Drug, and Cosmetic Act (FD&C Act):
- 21 CFR Part 11 – Electronic Records; Electronic Signatures. Governs the use of electronic systems in clinical investigations. Relevant for data integrity and compliance in digital recordkeeping.
- 21 CFR Part 50 – Protection of Human Subjects. Covers informed consent and ethical treatment of study participants. Applies to all FDA-regulated clinical investigations.
- 21 CFR Part 54 – Financial Disclosure by Clinical Investigators. Requires disclosure of financial interests that could affect the reliability of clinical data.
- 21 CFR Part 56 – Institutional Review Boards (IRBs). Sets requirements for the review and oversight of clinical investigations by IRBs to protect human subjects.
- 21 CFR Part 807 Subpart E – Premarket Notification [510(k)]. Discusses clinical data requirements that may be needed to support 510(k) submissions.
- 21 CFR Part 812 – Investigational Device Exemptions (IDE). The central regulation governing the conduct of clinical studies with investigational medical devices.
- 21 CFR Part 814 – Premarket Approval (PMA). Defines requirements for clinical data submitted in PMA applications and includes rules on clinical study design and evaluation.
- 21 CFR Part 820 – Quality System Regulation (QSR). Relevant for documentation and controls, especially § 820.30 – Design Controls, which can intersect with clinical evaluation processes.
- 21 CFR Part 822 – Postmarket Surveillance. Outlines requirements for postmarket surveillance studies under Section 522 of the FD&C Act.
- 21 CFR Part 822 – Postmarket Surveillance. Establishes requirements for certain manufacturers to conduct postmarket surveillance studies.
- Section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Authorises FDA to require postmarket surveillance studies under specified conditions (e.g., for Class II or III devices with serious risk).
Good Clinical Practice (GCP): While not codified in a single CFR part, GCP is enforced via:
Canada
Medical Devices Regulations (SOR/98-282)
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Sections 10–20 – Safety and effectiveness.
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Section 32 (2)(c), (3)(f), (4)(i)–(n) – Clinical evidence in licence applications
- Class II: attestation of objective evidence
- Class III: summary of supporting studies
- Class IV: full clinical data required
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Section 35 – Minister’s request for additional info.
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Section 39 – Post-market evidence requirements.
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Section 43.11 – Disclosure for clinical or investigational studies.
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Part 3 (Sections 79–88) – Investigational Testing Authorizations (ITAs).
United Kingdom
UK Medical Devices Regulations 2002:
- Regulation 16 – General requirements (including clinical investigation reporting). Covers notification, approval, and reporting obligations for clinical investigations
- Regulation 29 – Duties of manufacturers for clinical investigations. Defines manufacturer responsibilities for design, safety, ethical approval, and reporting
- Annex X (of Part II, Schedule 2A) – Clinical Evaluation Report (CER) requirements. Specifies the need for systematic collection and assessment of clinical data from literature, equivalence, and investigations
- Part II, Regulation 43 – Performance evaluation for IVDs. Mandates performance evaluation rather than clinical evaluation for in vitro diagnostic devices
- Part II, Regulation 56 – Fee and notification rules for clinical investigations. Details MHRA fee structure and lawful notification timing for clinical investigations
Australia
Therapeutic Goods (Medical Devices) Regulations 2002
- Part 3 — Inclusion of Medical Devices in the Register
- Part 4 — Essential Principles
- Schedule 1 — Essential Principles
- Part 5 — Conformity Assessment Procedures
- Part 6 — Clinical Investigations
International Standards:
510(k) Clearance: A premarket submission made to the U.S. Food and Drug Administration (FDA) to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA (Premarket Approval).
Acceptance Criteria: The predefined standards and specifications that a device must meet during testing and evaluation to be deemed suitable for its intended use and to comply with regulatory requirements.
Benefit-Risk Analysis: The comparison of a medical device’s benefits to its associated risks, often used in regulatory decision-making.
CE Marking: A certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA).
Clinical Context: The specific medical conditions, patient populations, and healthcare settings in which a device is intended to be used, influencing its design, functionality, and regulatory requirements.
Clinical Evaluation: A methodologically sound ongoing procedure to collect, appraise, and analyse clinical data about a medical device and to verify its safety and performance, including its clinical benefits. Also see Clinical Investigation.
Clinical Evaluation Plan (CEP): A structured document outlining the methodology and objectives for assessing the clinical performance and safety of a medical device or intervention.
Clinical Evaluation Report (CER): A comprehensive document that systematically analyses clinical data pertaining to a medical device to establish its safety and performance per regulatory requirements.
Clinical Investigation: Any systematic investigation or study in or on one or more human subjects undertaken to assess the safety or performance of a medical device.
Compliance: Adherence to regulations, standards, and guidelines set forth by regulatory authorities.
Conformity Assessment: A process used to determine whether a product, service, system, or entity meets specified standards, regulations, or requirements.
Endpoint: The measurable result at the end of a study, including types such as:
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Clinical Endpoint: A precisely defined and measurable outcome used to determine the effect of an intervention.
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Performance Endpoint: A measure of how well the medical device achieves its intended purpose.
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Primary Endpoint: The main result that is measured at the end of a study to see if the treatment worked (e.g., the change in a clinical measurement from baseline to the end of the study).
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Safety Endpoint: A measure of the frequency and severity of adverse events experienced by participants during a clinical trial.
Equivalency: Demonstrating that a new device is as safe and effective as an already marketed device by comparing its technical and functional characteristics.
Ethics Committee (Institutional Review Board - IRB): An independent group that reviews and monitors the ethical aspects of a clinical trial.
Good Clinical Practice (GCP): An international quality standard provided by the International Conference on Harmonisation (ICH) for the conduct of clinical trials involving human subjects.
Health Technology Assessment (HTA): A systematic evaluation of the properties, effects, and impacts of health technology, such as medical interventions, pharmaceuticals or medical devices, to inform healthcare decision-making.
Indication of Use: A concise statement specifying the medical conditions or purposes for which the medical device is intended to be used, as approved by regulatory authorities.
Informed Consent: The process through which a participant voluntarily confirms their willingness to participate in a study after being informed of all study aspects relevant to their decision to participate.
Instructions for Use (IFU): The document provided by the manufacturer that includes essential information on a medical device’s intended purpose, proper handling, operation, maintenance, and safety precautions for users.
Intended purpose: The use for which a medical device is intended according to the information provided by the manufacturer on the labelling, in the instructions for use (IFU), or in promotional materials. This may also be referred to as the Intended Use in some jurisdictions. Also see Indication of Use.
International Medical Device Regulators Forum (IMDRF): A global regulatory collaboration focused on harmonising medical device regulations to facilitate patient access to safe and effective devices. This organisation was formerly the Global Harmonization Task Force (GHTF).
Investigator: An individual who conducts a clinical investigation and is responsible for ensuring the study’s integrity and participants’ welfare. Also see Clinical Investigation.
Investigational Device Exemption (IDE): An exemption that allows a medical device to be used in a clinical study to collect safety and effectiveness data, typically required before a device can be marketed.
in vitro Diagnostics (IVD): Medical tests conducted on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections outside the body.
Labelling: The label on a medical device and all descriptive and informational literature associated with the device. Also see Instructions for Use (IFU)
Manufacturer: A legal entity that designs, produces, assembles, or labels a medical device with the intention of placing it on the market.
Mode of Action: The means by which a device achieves its intended therapeutic or diagnostic effect.
Notified Body (NB): An organisation designated by a country authority to assess the conformity of certain products before being placed on the market, ensuring they meet applicable regulatory requirements and standards.
Payer: An entity or organisation, such as an insurance company or government agency, responsible for reimbursing or funding healthcare expenses related to using health technologies.
Post-Market Surveillance (PMS): The proactive collection and review of experiences and data related to a device after it has been released onto the market to ensure continued safety and performance.
Predicate Device: An existing on-market device that provides a basis for comparison or reference in demonstrating substantial equivalence for regulatory purposes.
Real World Evidence: Clinical evidence regarding the use and potential benefits or risks of a medical product derived from real-world data (RWD) sources outside traditional clinical trials.
Regulation: The rules, laws, standards, and requirements set by regulatory authorities to ensure the safety, efficacy, and quality of devices intended for medical use.
Regulatory Authority: An official body overseeing and enforcing laws, regulations, and standards within a specific industry or sector to ensure compliance and protect public interests. Also known as a Regulatory Authority. Also see Competent Authority and Notified Body.
Regulatory Submission: The formal process of submitting documentation and data to regulatory authorities for review and approval to market or sell the device within a specific jurisdiction.
Reimbursement: The process of receiving payment from insurers, government health programs, or healthcare facilities for the use of medical devices in patient care.
Risk Management (RM): The systematic application of management policies, procedures, and practices to the tasks of analysing, evaluating, controlling, and monitoring risk.
Risk Management File (RMF): A compilation of all documents and records generated during the risk management process.
Safety: The condition of being protected from or unlikely to cause danger, risk, or injury.
Standard: A document that provides guidance, requirements, or specifications established by regulatory bodies, industry organisations, or international consensus groups.
State-of-the-art (SotA): The current knowledge or good practice acceptable in the medical devices industry.
Study Protocol: A document that describes the objectives, design, methodology, statistical considerations, and organisation of a clinical study.
Systematic Review: A structured and comprehensive synthesis of research studies that aims to identify, select, assess, and summarise the findings of all relevant individual studies on a particular topic.
Technical Documentation: All documents that demonstrate the design, manufacture, and performance of the device, essential for ensuring compliance with regulatory requirements. This is also known as the Technical File.
Traceability: The ability to verify an item’s history, location, or application by means of documented recorded identification.
Usability Engineering: The process of designing medical devices to ensure they are safe, effective, and easy to use by intended users under specified conditions.
User: Any individual who operates or interacts with a medical device, including healthcare professionals, patients, and caregivers.
Vigilance: The systematic process of monitoring, evaluating, and responding to safety issues and adverse events related to medical devices to ensure ongoing safety and compliance with regulatory standards.