What is BS EN 13612 - Performance evaluation of in vitro diagnostic medical devices about?
BS EN 13612 is a European standard that applies to the performance evaluation of in vitro diagnostic medical devices (IVD MDs) including IVD MDs for self-testing to maintain the acceptable performance of in vitro diagnostic medical devices.
BS EN 13612 specifies the responsibilities and general requirements for the planning, conduct, assessment, and documentation of a performance evaluation study by the manufacturer.
Where a manufacturer maintains a quality system BS EN 13612 addresses the compliance with "design validation" and "design changes" as described in EN ISO 9001, EN 46001, and EN 928 especially considering the nature and use of IVD MDs.
BS EN 13612 applies to in vitro diagnostic medical devices to:
- Show evidence to notified bodies and national authorities by results of a performance evaluation that the IVD MD performs as claimed by the manufacturer
- Establish adequate performance evaluation data originating from appropriate studies or resulting from available literature
- Satisfy the requirements of a quality system for design validation
Note: BS EN 13612 does not apply to specific evaluation plans for certain IVD MDs or specific use.
Who is BS EN 13612 - Performance evaluation of in vitro diagnostic medical devices for?
BS EN 13612 on the performance evaluation of in vitro diagnostic medical devices is useful for:
- In vitro diagnostic medical device manufacturers
- Coordinator or any entity involved in performance evaluation of in vitro diagnostic medical devices
- Test centres
Why should you use BS EN 13612 - Performance evaluation of in vitro diagnostic medical devices?
Performance evaluation studies performed in a clinical or other appropriate environment serve as evidence that the IVD MD performs as claimed, whether these claims are of a technical, analytical or diagnostic nature.
BS EN 13612 provides you with the general requirements on responsibilities, resources, documentation, final assessment, and review for the performance evaluation of in vitro diagnostic medical devices.
BS EN 13612 guides in the organisation of a performance evaluation study by providing you with preconditions, evaluation plan, sites, resources, basic design information, experimental design, performance study records, observations, unexpected outcomes, and evaluation reports.
With obedience and compliance to BS EN 13612, you can enhance the efficacy of in vitro diagnostic medical devices. In addition, minimise the hazards to operators and the patients.