TypeExamination

TypeExamination is a conformity assessment process used in regulatory contexts to verify that a product type meets essential safety and performance requirements before it is manufactured or placed on the market. It is applied when the characteristics of a single product can be proven to represent all future units of that product, reducing the need for repetitive testing of each unit.

In the European Union, the term is often encountered as EC-type examination. A Notified Body evaluates the technical design, drawings, risk assessment, and test results of a defined product type against the applicable requirements. The assessment may include tests on representative samples and a review of the manufacturer's quality management arrangements. If the design and documentation meet the requirements, the Notified Body issues an EC-Type Examination Certificate, which demonstrates that the product type conforms to the essential requirements. The certificate is typically a prerequisite for issuing a Declaration of Conformity and placing CE marking on the product, and it may be combined with further conformity assessment modules covering production control or post-market surveillance.

Outside the EU, similar type-examination schemes exist under national or regional regulatory frameworks and under international standards. TypeExamination is not an approval of every individual unit; it focuses on the selected product family and provides ongoing assurance that subsequent units of the same type remain compliant, subject to changes in design or production.

This article provides a general overview; implementation details vary by jurisdiction and by product category.