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)
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).
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:
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.
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.
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)
