BS EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects. General requirements
The standard defines the procedures for the conduct and performance of clinical investigations of medical devices, where their clinical performance and safety is being assessed in people.
It is intended to protect people and to ensure the scientific conduct of the clinical investigation.
BS EN ISO 14155-1 specifies requirements for the organization, conduct, monitoring, data collection and documentation of the clinical investigation of a medical device, as well as specifying requirements that establish the performance of the device under conditions intended to mimic normal clinical use, thereby revealing adverse events in normal use and allowing the assessment of acceptable risks.
BS EN ISO 14155-1 now contains informative annexes detailing the relationship between this standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices, and of the EU Directive 90/385/EEC on Active Implantable Medical Devices.
BS EN ISO 14155 consists of the following parts, under the general title
Clinical investigation of medical devices for human subjects:
- Part 1: General requirements
- Part 2: Clinical investigation plans
BS EN ISO 14155-1 defines procedures for the conduct and performance of clinical investigations of medical devices. It specifies general requirements intended to:
- Protect human subjects
- Ensure the scientific conduct of the clinical investigation
- Assist sponsors, monitors, investigators, ethics committees, regulatory authorities and bodies involved in the conformity assessment of medical devices.
BS EN ISO 14155-1 applies to all clinical investigation(s) of medical devices whose clinical performance and safety is being assessed in human subjects.
BS EN ISO 14155-1 specifies the requirements for:
- The conduct of a clinical investigation such that it establishes the performance of the medical device during the clinical investigation intended to mimic normal clinical use, reveals adverse events under normal conditions of use, and permits assessment of the acceptable risks having regard to the intended performance of the medical device
- The organization, conduct, monitoring, data collection and documentation of the clinical investigation of a medical device.
Contents of BS EN ISO 14155-1 include:
- Normative references
- Terms and definitions
- Justification for a clinical investigation
- Ethical considerations
- Declaration of Helsinki
- Improper influence or inducement
- Compensation and additional health care
- General requirements
- Formal agreement(s)
- Clinical investigation plan
- Design of the clinical investigation
- Start of clinical investigation
- Informed consent
- Suspension or early termination of the clinical investigation
- Document and data control
- Accounting for subjects
- Access to preclinical and clinical information
- Clinical investigator's brochure
- Other documents
- Responsibilities of sponsor
- Responsibilities of monitor
- Clinical investigator
- Qualification of clinical investigator
- Responsibilities of clinical investigator
- Final report
- Presentation of results
- Contents of the final report
- Suggested procedure for literature review
- Information for the ethics committees
- Final reports of clinical investigations with medical devices
BS EN ISO 14155-1 is intended to be applied worldwide to clinical investigations of medical devices in order to fulfil the technical aspects of the various national, regional and international regulatory requirements.
As the legal regulatory requirements presently differ throughout the world, regulatory specifics have been excluded from the scope of this part of ISO 14155. They are part of national or regional legislative texts and can be referenced in the national or regional forewords, as appropriate.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom.
Part 1 of BS EN ISO 14155 dos not apply to in vitro diagnostic medical devices.
BS EN ISO 14155-1:2009 supersedes BS EN ISO 14155-1:2003 which has been withdrawn.