Ability of a medical device or material to perform with an appropriate host response in a specific application. (EN 10993-1:2020-Article 3.1)
Biocompatibility is a general term describing the property of material being compatible with living tissue. The ambiguity of the term reflects the ongoing development of insights into how biomaterials interact with the human body and eventually how those interactions determine the clinical success of a medical device. Biocompatible materials do not produce a toxic or immunological response when exposed to the body or bodily fluids.
Clinical Benefit means the positive impact of a device on the health of an individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis, or a positive impact on patient management or public health. (MDR-Chapter 1, Article 2)
Clinical Evaluation means a systematic and planned process to continuously generate, collect, analyse, and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer; (MDR-Chapter 1, Article 2)
Clinical Investigation means any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device; (MDR-Chapter1, Article 2)
Clinical trial for medical devices is scientifically and ethically designed investigation to gather information regarding a medical device when used in human subjects when designing and running a clinical investigation for medical devices ISO 14155:2020 Clinical investigation of medical devices for human subjects — Good clinical practice, ICH GCP, Helsinki Declaration and local regulatory requirements should be followed.
It is an ethical and scientific quality standard for designing, conducting, collecting and reporting of clinical trials on humans’ subjects. It provides reassurance to the patients that their rights, health and privacy are protected and that the data obtained from the investigation is reliable.
The performance Evaluation report results from the performance evaluation of an In-vitro Diagnostic Device in question. It is a continuous process performed by the manufacturer to generate, collect, analyze and assess performance data of the In-vitro Diagnostic device in order to be able to show safety and performance.
Post Market Clinical Follow-up trials are clinical trials performed on a medical device bearing CE marked with the approved indication(s).
For this kind of investigations the approval is rather easier to obtain than pre-market studies. Particularly for non-interventional observational studies, the approval process is much simpler and, in many countries, the reimbursement of treatment is done as in routine use.
When the clinical trial is designed as randomized, patients recruited for the study are randomly distributed to different groups (2 or more) for comparison. Such studies are highly scientific and carry very little bias, especially if randomization and the study are appropriately designed.
While post-market studies can be designed both prospectively and retrospectively, since medical devices that have not yet received CE certificates are pre-market, their clinical studies cannot be retrospective. Pre-market studies can only be designed as interventional prospective studies. For this reason, the Ethical Committee and Competent Authority approvals of pre-market products may take more time than in post-market studies as they would be investigated by the authorities cerefully and in a more detailed manner in order to make sure the device or the treatment does not create more risks than benefits to the patients.
SSCP stands for Summary and Safety of Clinical Performance to be prepared by class III and implantable device manufacturers by Article 32 of Medical Device Regulation (MDR). It should be validated by the Notified Body involved in the conformity assessment process and uploaded to EUDAMED following its validation. The manufacturers should provide the access link to the SSCP in EUDAMED on the product label or instruction for use. (AdviQual Definition)
Patients included in the study are called subjects according to current ISO 14155, and before being included in the study, they must sign an "Informed Consent Form" (ICF) indicating that they agree to participate in the study and they are fully aware of all the procedures, requirements, risks and benefits of the treatment and the device. In cases where the number of patients to be included according to the clinical trial protocol is high, more than one center can be selected as a trial site in order to include patients in the trial within a reasonable time frame. This should be planned and stated in the clinical trial protocol.
Clinical evaluation report (CER) results from the clinical evaluation process of the medical device, performed following the clinical evaluation plan. Written and updated by the manufacturer in order to show conformity to GSPR (General safety and performance requirements)
Clinical data means information concerning safety or performance that is generated from the use of a device and is sourced from the following:
Each hospital where the clinical investigation is carried out is called a clinical investigation site or center.
These are the performance and/or safety criteria that are intended to measure /evaluate the device in question with the clinical trial. They must be specified and defined in the clinical trial protocol. They are determined according to the intended use of the device and the expected benefit-risk as well as the expected performance measurement of the device related to its clinical claims. Accurate determination of endpoints is important for the relevance of clinical data collected at the end of the clinical study for the device.
It is the ISO standard to be followed when designing and conducting a clinical trial with medical devices on human subjects.
Proactive clinical follow up of the CE marked medical devices with approved indication. PMCF activities can be thoroughly designed and run clinical trials under MDR and ISO 14155, registries, retrospective studies or well-designed surveys with performance-related questions.
She/he is the lead investigator of the study, responsible for managing the clinical trial (at all centers where the study is conducted). If the clinical trial is conducted in more than one center, there are investigators at each center other than the principal investigator. The investigator(s) in each center is responsible for their own center and conducts the study in coordination with the principal investigator.
Patient data are collected prospectively. Patients are included in the study and treated with the device in question after all approvals and consents are received.
a) Observational: In observational clinical studies, researchers follow human subjects within an investigation plan/protocol.
Patients can receive interventional therapy that includes a medical device as routine therapy, but researchers cannot use any specific interventional therapy and/or examination other than those included in routine procedure. The study should be based on the approved indication of the product.
The product should be used routinely in the study center.
b) Interventional: In interventional clinical studies, researchers follow patients within an investigation plan/protocol.
While the patients are undergoing a treatment in which the medical device will be used, the investigator may perform non-routine testing, imaging and diagnostic interventions to answer specific questions.
An existing device can be compared with a new device, two different treatment methods can be compared, and specific questions can be answered with different interventions/imaging.
These studies are based on retrospective data collection. In order to carry out such a study, the data pertaining to patients who have already been treated with the investigational device in question prior to the study initiation in the centers should be available in accordance with the intended study.
These are studies that ensure the determination of the number of patients to be included in the clinical trial in order to be able to collect and reach statistically meaningful results, the formation of statistical hypotheses about the desired result, the methods and models through which the obtained data will be interpreted, and the scientific evaluation of the results. All this information about patient number calculation as well as the plan regarding how to analyse the collected data is given in the statistical analysis plan of the trial.
