In 1985 a European Council of Ministers resolution defined the "New Approach" to achieving technical harmonization. It created a distinct separation of responsibility between the EU legislator and the European standards bodies, who have the task of drawing up the corresponding technical specifications that will meet the essential requirements of the directives.

Compliance with these so-called "harmonized standards" provides a presumption of conformity with the essential requirements. Interestingly, compliance with harmonized standards remains voluntary, and manufacturers are free to choose any other technical solution that provides compliance with the essential requirements of the EC directives. However, conformance with harmonized standards represents the most expected route to certification and the route for which most expertise exists.

The list of Directives which can be met through harmonized standards is published on the EU Commission website. This lists the harmonized standards for Medical Devices, In Vitro Diagnostic Devices, and Active Implantable Medical Devices.

Priory Analysts frequently reminds clients that compliance with harmonized standards is not mandatory.