Common Specifications & Harmonized Standards

Common Specifications introduced in the European regulatory scheme for medical devices and IVDs

Definition

Common Specifications means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system.”

Purpose

The concept of Common Specifications has been introduced in the new MDR and IVDR. They are defined as a set of technical and/or clinical requirements — other than a standard — that provide a means of complying with the legal obligations applicable to a device, process, or system when no harmonized standards exist, when relevant harmonized standards are not sufficient, or when there is a need to address public health concerns.

Devices that conform to a Common Specification are presumed to conform with the regulatory requirements covered by that common specification — similar to the approach with harmonized standards. But, the MDR and IVDR state that compliance with Common Specifications is mandatory, unless the manufacturers can justify an equivalent level of safety and performance through other methods. The use of harmonized standards is good practice in order to presume to be in conformity with the General Safety and Performance Requirements. But in case relevant harmonized standards are considered not sufficient, or perhaps even not existing, the Commission may adopt Common Specifications which will have the same use as the harmonized standards. Specifically, regarding IVDs, current Common Technical Specifications may be replaced by such Common Specifications.

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