Design Examination Certificate definition
Design Examination Certificate means certification that the examination of a medical device by a Notified Body has proven that the design of such medical device meets the requirements of the applicable European Council Directives, such as European Council Directive 93/42/EEC.
Examples of Design Examination Certificate in a sentence
If you lodge an application for examination of the design with TÜV UK, we shall examine the application, and where the design meets the requirements of PESR that apply to the pressure equipment, we shall issue a Design Examination Certificate to you.
Such modifications shall require additional approval in the form of an addition to the original Design Examination Certificate.
The BSI Design Examination Certificate No. CE [redacted] and BSI Full Quality Assurance No. [redacted] are not transferrable.