Glossar

A clinical investigation is any systematic investigation involving one or more human subjects, undertaken to assess the safety and performance of a device.

A clinical investigation plan (CIP) displays the rationale, objectives, design, methodology, monitoring, statistical considerations, organization and conduct of a clinical investigation.

A clinical investigation report (CIR) describes the design, execution, statistical analysis and results of a clinical investigation.

The clinical investigator is described as an individual responsible for the conduct of a clinical investigation at a clinical investigation site.

Clinical performance describes the ability of a medical device to achieve its intended purpose as claimed by the manufacturer.

Clinical safety is described by the absence of unacceptable clinical risks, when using the device according to the manufacturer’s Instructions for Use.

The comparator can be a medical device, therapy (e.g. active control), placebo or no treatment, used in the reference group in a clinical investigation.

A competent authority is any person or organization that has the legally delegated or invested authority, capacity, or power to perform a designated function.
Clinical investigations for medical devices and performance evaluations of in vitro diagnostic agents in Germany must be approved by the competent authority and approvingly evaluated by an Ethics Committee before they may commence.

Competent authorities in Germany are BfArM and PEI.

Compliance describes the adherence to all the trial-related requirements, Good Clinical Practice requirements, and the applicable regulatory requirements.

Conformity assessment means the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled.

A person or organization contracted by the sponsor to perform one or more of the sponsor's clinical investigation-related duties and functions.

Clinical investigator who is appointed by the sponsor to coordinate work in a multicentre clinical investigation.

Corrective action means action taken to eliminate the cause of a potential or actual non-conformity or other undesirable situation.

Corrective and preventive action (CAPA) is a process which investigates and solves problems, identifies causes, takes corrective action and prevents recurrence of the root causes.

A custom-made device is a medical device which is especially manufactured according to a written prescription and with specific design features and intended for the exclusive use of a patient designated by name. Mass-produced medical devices which need to be adapted to suit the specific requirements of the physician, dentist or other professional user, are not regarded as custom-made medical devices.