Definitions for clinical trials with medical devices

The EU Medical Device Regulation (MDR), number 2017/745, defines and explains terms that are also relevant to clinical trials and are therefore briefly explained here. The complete list can be found in Art. 2 of the EU MDR. For Germany, the Medical Devices Implementation Act (MPDG) also applies, for which further terms are listed below.

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Active product: Depends on an energy source other than the energy generated by the human body or gravity. It acts by changing the density or conversion of this energy. Software is also considered an active product.

‍User: Any healthcare professional or layperson who uses a medical device. In addition to laypersons (see below), this also includes persons with medical or nursing training.

‍Notifiedbody: A conformity assessment body designated in accordance with the Medical Device Regulation (EU MDR 2017/745). This may be involved as part of the clinical investigation process.

‍CE conformity marking: A marking indicating that a device complies with the relevant requirements of this Regulation or other Union legislation. Clinical trials with medical devices that bear a CE mark are structured differently in terms of objective and regulation and therefore involve significantly less effort than trials of devices that do not yet bear this mark.

Informed consent: The voluntary consent of trial participants after they have been fully informed about all relevant aspects of the clinical trial. In the case of minors or persons incapable of giving consent, approval is given by the legal representatives.

Consent to the processing of personal data: All trial participants must give their informed consent in written or electronic form to any processing of their data, in particular their health data. This also includes pseudonymization, anonymization, storage, purpose of use and, of course, the revocation of this consent.

‍Ethics Committee: An independent body established in accordance with national legislation with the power to issue opinions for clinical trials or performance studies or "other clinical trials" before they start. This includes consideration of the views of lay persons, in particular patients or patient organizations. NO clinical trial on patients may be started or even conducted before this opinion and the "approval" by the ethics committee has been obtained.

Common specifications (CS): Technical and/or clinical requirements that are not standards but enable compliance with legal obligations for a product, process or system.

‍Healthcare facility: An organization whose primary purpose is the care or treatment of patients or the promotion of public health. Generally understood to include hospitals, research clinics or medical practices.

Principal investigator: If several physicians are involved in a clinical trial, a performance study or an "other clinical trial" at a trial center, one of these physicians is designated by the sponsor as the principal investigator. This is regulated for Germany in § 30 MPDG. Principal investigators may also be persons from other professions if their training entitles them to exercise a profession that qualifies them to conduct a clinical trial, a performance study or another clinical trial. See also "Investigator" or more here. For the duties and tasks of principal investigators, see here.

‍Interoperability: The ability of two or more products to exchange information, communicate with each other or work together, regardless of the manufacturer.

‍Labeling: Written, printed or graphic information on the product, packaging or in sales materials.

Clinical data: Safety or performance information obtained from clinical trials or from the scientific literature either with the device in question or a device that can be shown to be similar to the device in question, or from post-market surveillance.

‍Clinicalevaluation: A systematic process for evaluating the clinical data of a device to verify the safety and performance, including clinical benefit, of the device when used as intended by the manufacturer. For this purpose, a clinical trial may be necessary if there is no comparability with another device for which there are already results from the literature. See more here.

Clinical performance: The ability of a device, based on its technical or functional characteristics, including diagnostic features, to fulfill the function intended by the manufacturer. Direct or indirect medical effects should be taken into account in order to achieve a clinical benefit for patients.

‍Clinicalevidence: Clinical data and results that are sufficient to make a qualified judgment as to whether a product is safe and effective when used as intended.

Clinical benefit: Positive effects of a product on a person's health as measured by meaningful, measurable and patient-relevant clinical outcomes, including diagnostic results. This also includes positive effects on patient management or public health. Often also referred to as medical benefit, see also here.

‍Clinicaltrial protocol: A document that describes the objectives, methodology, monitoring and conduct of a clinical trial. For more see also here.

‍Clinicaltrial: A systematic investigation with human subjects to evaluate the safety or performance of a device, see also here.

‍Conformity assessment: A procedure to determine whether a product meets the requirements of the applicable regulation. A clinical investigation can be carried out as part of a conformity assessment procedure or after it has been completed. The objective, the applicable laws and therefore the cost of the clinical trial depend largely on this.

Corrective action: Action to eliminate the cause of a potential or existing non-compliance or other undesirable situation.

‍Laie: A person without formal training in healthcare or a medical specialty. This can be patients, relatives or other people who have no training in the medical or nursing field.

Head of a clinical trial: These are physicians who must be at least sufficiently qualified and have at least two years of experience in clinical trials of medical devices or in conducting interventional clinical performance studies with in-vitro diagnostics (regulated for Germany in § 30 MPDG). See more here.

‍Performance: The ability of a product to fulfill its purpose as specified by the manufacturer.

‍Medical device: See more here.

‍Benefit-risk assessment: The analysis of all assessments of benefits and risks relevant to the intended use of a device as stated by the manufacturer. This assessment is also always carried out by physicians before a clinical trial may be started and is subsequently carefully reviewed by the ethics committee or authorities.

Product Defect: An inadequacy in the identification, quality, durability, reliability, safety or performance of a test product, including malfunctions, application errors or inadequate information provided by the manufacturer.

‍Investigator: Also known as an investigator. Investigators are responsible for conducting a clinical trial or performance study or "other clinical trial" at a trial site (also trial center) and must be "appropriately qualified". In exceptional cases, persons from other professional groups with sufficient qualifications can also take on the role of investigator. This is regulated by the MDR and for Germany § 30 MPDG. More on this can be found here. For the duties and tasks of inspectors, see here.

Investigational product: A product that is evaluated as part of a clinical trial. For more see also here.

‍Trial participant: Also study participant. Is a person who takes part in a clinical trial.

‍Risk: The combination of the probability of a loss occurring and the severity of this loss.

Serious public health hazard: An event involving an immediate risk of death, serious deterioration in health or serious illness that may cause significant morbidity or mortality and is unusual or unexpected for a particular place and time.

Serious adverse event: An adverse event with serious consequences such as death, life-threatening illness, permanent damage or hospitalization. Fetal harm or birth defects are also considered serious adverse events. Immediate corrective action is required. More on this can be found here.

Serious incident: An incident with serious consequences such as death, serious deterioration of health or a serious risk to public health.

‍Field safety corrective action: Action taken by the manufacturer to prevent or reduce the risk of serious incidents associated with a product made available on the market.

Safety instruction in the field: Message sent by the manufacturer to users or customers in connection with a safety corrective action in the field.

‍Sponsor: A person or organization that assumes responsibility for the initiation, management and funding of a clinical trial. See also more here.

Adverse event: An adverse medical event, unintended illness or injury to subjects, users or other persons in the context of a clinical trial, regardless of any connection to the investigational product. More information can be found here or also here for serious adverse events.

Insurance cover: In a clinical trial, a performance study or any other clinical trial, the persons concerned must be insured for injury to health or body or death. There are only exceptions to this if the investigational device is CE-marked and is being tested within the scope of its intended purpose in another trial, there are no additional stressful or invasive measures for the trial, no additional personal visit takes place and there is other insurance cover for the sponsor or investigator (Section 26 MPDG).

‍incident: malfunction, deterioration or inadequacy of a product already made available on the market, including errors in use or undesirable side effects. See also "serious incident".

‍Intended use: Designates the intended use of a product as specified by the manufacturer on the label, in the instructions for use or in advertising material.