How do notified bodies ensure a uniform handling of product documentation so that the results are the same regardless of which body is chosen from EU list?

When a manufacturer seeks official confirmation that their product complies with the relevant directive, they can request a notified body to examine their product documentation. However, how are these bodies aligned to ensure that the examination outcomes are practically the same, regardless of the chosen notified body? This consistency is crucial, as manufacturers cannot simply switch to another body if they disagree with the initial examination results.

The available set of standards is never complete

Manufacturers often encounter a lack of applicable standards for specific products, a challenge that has persisted since the EU introduced the new approach where directives outline essential requirements and referenced standards provide a straightforward means of compliance.

While the number of available standards has increased as directives have matured, gaps often arise when directives change or when technology evolves faster than the development of new standards.

Risk (of non-compliance) assessment

Directives require that essential requirements be met, and manufacturers are expected to conduct a risk assessment for non-compliance to demonstrate due diligence. This assessment is straightforward when harmonised standards (HS) that provide a presumption of conformity are fully applicable. However, when such standards are unavailable or do not adequately cover the product's intended use, manufacturers must address these gaps and mitigate identified risks through alternative means.

In many cases, directives permit manufacturers to argue compliance based on relevant standards not listed as HS or to supplement partially applicable standards with relevant tests.

Obligations of notified bodies

Directives and other EU legislation impose significant requirements on the community of notified bodies and on each body individually. These requirements pertain to procedures, communication, control, impartiality, active maintenance of competency, and participation in alignment activities within the notified body community.

A complete list of notified bodies can be found in the EU’s Nando database (New Approach Notified and Designated Organisations), which offers multiple search functions to help identify the notified body for a specific directive.

If a notified body must refuse, withdraw, restrict, or suspend a certificate, it is obligated to inform the relevant EU and national authorities, as well as all other notified bodies.

FORCE Certification A/S

Following the merger between DELTA and FORCE Technology, DELTA’s notified body services continue under FORCE Certification A/S. While our services remain largely the same, the main difference is that services previously listed under DELTA’s notified body number 0199 have been reduced, with continued services now available under notified body number 0200.

More info

For further information, please contact Senior Specialist Ole Hammer, tel. +45 43 25 15 90.