Introduction
Clinical investigations (CIs) are critical to demonstrating the safety and performance of medical devices, especially when there is insufficient pre-existing clinical evidence to support a product’s intended use. These studies are pivotal in every aspect of market access, from regulatory submissions to payer negotiations and sales and marketing to customers. However, the regulatory landscape for clinical investigations is complex and varies across regions.
This article explores the essential elements of clinical investigations for medical devices, highlighting when and why they are required. It also provides a guide to key regulations and standards, focusing on the EU, U.S., and international frameworks.
What are clinical investigations?
A clinical investigation (also referred to as a clinical study or clinical trial) is a systematic study conducted in human subjects to assess a medical device’s safety and performance or effectiveness.
These investigations may be:
- Interventional, where the device is used to assess performance outcomes under controlled conditions.
- Observational, where existing device users are monitored without altering the clinical routine.
Clinical investigations are required for many devices, especially novel or high-risk ones, to gather robust clinical evidence supporting regulatory submissions and other market access activities.
When are clinical investigations required?
The need for clinical investigations depends on a range of factors, including:
- Risk classification: Higher-risk (Class III and some Class IIb) devices often require new clinical data.
- Novelty: Devices based on new technology or intended for new indications usually need clinical investigation.
- Sufficiency of existing data: New data may be needed if existing clinical data (from literature or equivalent devices) is inadequate.
- Post-market obligations: Clinical investigations may also be conducted post-market to address safety concerns, perform validation, or fulfil post-market clinical follow-up (PMCF) requirements.
Regulatory landscape
The following is a summary of the regulatory requirements in major markets. Links to regulations in the EU, U.S.A, Canada, Australia and the U.K. can be found in the Resources section at the end of the article.
In the EU, the Medical Device Regulation (EU) 2017/745 (MDR) significantly tightened clinical evaluation requirements. Key provisions include:
- Article 62–82: Detailed rules for clinical investigations, including ethical approval, informed consent, and protection of vulnerable subjects.
- Annex XV: Lays out the requirements for the content of the clinical investigation application, clinical investigation plan (CIP), and investigator brochure (IB).
- EUDAMED: Mandatory registration of clinical investigations on the European database on medical devices.
- Notified Bodies (NBs): For high-risk devices, the notified body must review the clinical evaluation report (CER) and can require additional clinical investigations.
Under MDR, the bar for using equivalence data has been raised, especially for implantable and Class III devices, making manufacturer-sponsored clinical investigations more common.
In the U.S., the Food and Drug Administration (FDA) regulates medical device clinical investigations under:
- 21 CFR Part 812: Investigational Device Exemptions (IDE)
- 21 CFR Part 50: Protection of human subjects
- 21 CFR Part 56: Institutional Review Boards (IRBs)
For significant risk (SR) devices, an IDE submission and FDA approval are required before initiating the study. Only IRB approval is needed for non-significant risk (NSR) devices, though FDA oversight still applies.
FDA emphasises Good Clinical Practice (GCP) and may inspect investigation sites to ensure compliance.
The global gold standard for clinical investigations is ISO 14155:2020 – Clinical investigation of medical devices for human subjects — Good clinical practice. This standard aligns with the principles of the Declaration of Helsinki and supports harmonisation across regions.
Highlights of ISO 14155 include:
- Roles and responsibilities of sponsors, investigators, and ethics committees.
- Risk management throughout the investigation.
- Requirements for the Clinical Investigation Plan (CIP), case report forms (CRFs), and monitoring.
- Data integrity, adverse event reporting, and final reporting.
Although ISO 14155 is a standard rather than a regulation, regulators, notified bodies, and sponsors conducting multinational studies often expect or require compliance.
The clinical investigation process
A typical clinical investigation for a medical device involves a series of stages, which can last months to years depending on the study design and complexity.
- Define study objectives and endpoints.
- Conduct a risk-benefit analysis. This systematic assessment weighs the potential risks (such as harm, discomfort, or adverse events) to participants against the anticipated benefits (such as improved health outcomes, scientific knowledge, or societal value). This analysis helps determine if the trial is ethically justifiable and whether safeguards are adequate to minimise risks while maximising potential benefit.
- Draft the Clinical Investigation Plan (CIP), the formal protocol that describes a clinical investigation’s objectives, design, methodology, monitoring, and analysis, guiding its conduct and ensuring compliance.
- Prepare supporting documents:
- Investigator’s Brochure (IB): A comprehensive document that provides clinical and non-clinical data about an investigational product to investigators and trial staff, supporting a clinical trial’s safe and proper conduct.
- Informed Consent Form (ICF): This is a document given to potential trial participants that explains the study’s purpose, procedures, risks, and benefits, ensuring they voluntarily agree to participate with full understanding.
- Case Report Form (CRF): A standardised tool (paper or electronic) used to collect data on each trial subject as specified by the clinical investigation plan, ensuring consistent documentation of study variables.
Designing clinical investigations presents challenges such as poor protocol design with unclear endpoints, inappropriate patient selection, underpowered studies that fail to show meaningful effects, non-compliance with ISO 14155 leading to regulatory hurdles, and data integrity issues that can compromise the credibility and acceptance of study results. It is crucial to design studies that align with expectations for the specific device type by considering evidence from existing literature and comparable devices, ensuring the investigation addresses known risks and performance requirements. Additionally, reviewing guidance from regulatory authorities and health technology assessment (HTA) bodies helps ensure the study design meets current standards for safety, effectiveness, and market access, reducing the risk of delays or rejection.
Ethical oversight is fundamental to any clinical investigation. The following principles must be respected:
- Informed consent: Subjects must be informed of the risks, benefits, and their right to withdraw at any time.
- Independent ethical review: All studies must be approved by an independent ethics committee or IRB.
- Subject safety: Ongoing risk assessment and adverse event reporting are mandatory.
- Vulnerable populations: Extra protections are required for minors, pregnant women, or those unable to provide informed consent.
The ethics or review process begins by submitting the clinical investigation plan (CIP), Investigator’s Brochure, Informed Consent Form, and other relevant documents to the relevant Ethics Committee or Institutional Review Board (IRB). Regulatory submissions may include:
- Submit to the ethics committee or Institutional Review Board (IRB), independent groups that review and approve clinical study protocols to ensure the study is ethically sound and scientifically valid and that participant rights and safety are protected.
- Submit to national competent authority (e.g., BfArM in Germany, ANSM in France), or regulatory authority (e.g., US FDA), depending on the local laws applying to the jurisdictions where the studies are being conducted.
The investigations can legally commence only after ethics approval (and often separate regulatory authority approval). The committee monitors significant amendments and may review ongoing safety data during the trial.
Insufficient regulatory engagement, such as failing to consult with regulators early in the clinical investigation planning process, can lead to avoidable delays and costly protocol amendments if the study design does not meet regulatory expectations. Early dialogue helps clarify requirements, align on endpoints, and identify potential issues, increasing the likelihood of smooth approval and market access. Proactive communication also builds trust and demonstrates a commitment to compliance and patient safety.
Site preparation for a clinical investigation involves several critical steps to ensure the study runs smoothly and complies with regulatory and ethical standards.
- Investigators and clinical staff must be thoroughly trained on the study protocol, investigational product, informed consent process, and safety reporting requirements.
- Robust data management systems must be set up to ensure accurate, consistent, and secure collection and handling of study data.
- Quality assurance procedures and monitoring protocols must be established to verify that the trial is conducted according to the approved plan and that participant safety and data integrity are maintained throughout the study.
- Analyse data following the statistical analysis plan documented in the CIP.
- Prepare a Clinical Investigation Report (CIR).
- Integrate findings into the Clinical Evaluation Report (CER) or other technical documentation and regulatory dossiers.
The CIR provides a detailed account of a specific clinical trial’s design, conduct, results, and conclusions, focusing on how the study was carried out and its findings. In contrast, the CER evaluates all available clinical data—published literature, post-market data, and clinical investigations—to assess the overall safety and performance of the device.
The CIR should feed into and support the CER by providing robust, trial-specific evidence that contributes to the broader clinical evaluation of the device.
Post-Market Clinical Follow-up (PMCF) is a proactive process conducted after a medical device is placed on the market to continuously gather clinical data on its safety, performance, and long-term benefits under real-world conditions. PMCF helps identify any previously unknown risks, verify that benefits continue to outweigh risks, and support updates to the clinical evaluation report (CER).
How PMCF is implemented can vary across countries:
- In the EU (under MDR 2017/745), PMCF is a mandatory, structured part of post-market surveillance, with detailed requirements for PMCF plans and reports.
- In the U.S., while PMCF as defined by MDR doesn’t exist, the FDA may require post-approval studies or 522 postmarket surveillance studies for certain devices.
- In other markets (e.g., Australia, Canada, Japan), post-market data collection requirements exist, but the formality, reporting frequency, and expectations for clinical data depth may differ depending on local regulations and risk classification.
Successful PMCF planning often requires tailoring the approach to meet regional regulatory expectations and the device’s risk profile, while generating different types of clinical evidence that satisfy regulators and address the needs of other key stakeholders, such as payers, HTA bodies, and customers. It is important to recognise that there is an evidence hierarchy—where data from well-designed clinical investigations generally carries more weight than real-world data or literature—yet all forms of evidence contribute to demonstrating safety, performance, and value.
Sometimes, regulatory dossiers can be submitted without all endpoints fully collected, provided that sufficient evidence exists to support a positive benefit-risk profile at the time of submission, with remaining data gathered post-market. The core purpose of PMCF is to evaluate the real-world performance, safety, and long-term benefits of a device beyond the controlled conditions of pre-market clinical trials, helping to identify any emerging risks and confirm that the device continues to deliver expected outcomes in routine use.
Conclusion
Clinical investigations are a cornerstone of medical device development, particularly under the stricter requirements of the EU MDR and the FDA’s evidence-based pathways. Manufacturers must navigate a web of regulations and standards, chief among them ISO 14155, to ensure investigations are ethical, scientifically valid, and regulatory compliant.
While the complexity of clinical investigations can be daunting, a well-designed, well-executed study supports regulatory approval and builds trust with clinicians, patients, and investors.
By understanding the regulatory frameworks, adhering to global standards, and committing to ethical conduct, manufacturers can turn clinical evidence into a powerful asset for product success and patient safety.
Engaging a Contract Research Organisation (CRO) to design and conduct clinical investigations can be helpful. When selecting a CRO, prioritise partners with proven experience managing studies for similar device types, as they’ll better anticipate technical and regulatory challenges; ensure they operate under a robust quality management system (QMS) aligned with ISO 14155 and applicable regulations; and assess their capability to identify and secure appropriate trial sites with the right patient populations, infrastructure, and investigator expertise to support high-quality, compliant data collection.
Resources
This section contains the guidelines on clinical investigations provided by regulatory authorities. Some of these documents also contain guidance relevant to clinical evaluation.
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:
- Article 62 – General requirements for clinical investigations. Principles, ethical considerations, informed consent, safety measures
- Article 63 – Clinical investigations for CE-marked devices. When additional data is needed post-market
- Article 64 – Clinical investigations in emergency situations. Special consent procedures
- Article 65 – Other clinical investigations. Investigations not intended for CE marking
- Articles 70-77 – Procedures for clinical investigation applications, reporting, and supervision. Including submission, assessment, and registration in EUDAMED
- Annex XIV Part A – Clinical evaluation. Requirements for planning and documenting the clinical evaluation, including the role of clinical data
- Annex XIV Part B – Post-market clinical follow-up (PMCF). Requirements for PMCF plans and reports
- Annex XV – Clinical investigations. Detailed requirements for the design, conduct, recording, and reporting of clinical investigations, including technical documentation to be submitted
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.