Notified bodies as guarantors of product safety

Notified bodies as guarantors of product safety

Accreditation, notified bodies and NANDO explain the pillars of EU product safety and their role in enabling the free movement of goods.

Accreditation as the basis for competence assessment

Accreditation is a process by which the competence of a conformity assessment body is officially recognized. This includes, among others, laboratories, inspection bodies and certification bodies. Accreditation confirms that these institutions possess the necessary technical capabilities and expertise to perform their specific tasks correctly and reliably.

This procedure is central in both regulated and non-regulated sectors. It plays a major role in strengthening public, industry and authority confidence in the credibility and reliability of conformity assessments. Accreditation is carried out according to internationally recognized standards, such as the ISO/IEC 17000 standards, enabling global comparability and recognition.

Notified body as an EU-specific role

A notified body is an organization officially designated by an EU member state and reported to the European Commission. Its primary task is to assess whether certain products comply with the applicable EU directives and regulations. This assessment is an indispensable step before products are placed on the market in the European single market.

Notified bodies check whether products meet the relevant EU legal requirements, including specific safety, health and environmental standards. Their work covers various sectors, including medical devices, machinery, construction products and personal protective equipment. The independence and impartiality of notified bodies are of the highest importance to ensure the integrity of the conformity assessment process.

Regular review and the NANDO system

The competence of notified bodies is periodically reviewed by accreditation bodies and national authorities. These audits are essential to ensure that notified bodies continuously meet the required standards and keep their expertise up to date. Reviews cover both technical competence and compliance with independence and impartiality requirements.

The NANDO information system (New Approach Notified and Designated Organisations) of the European Commission plays a central role in this process. It is a publicly accessible online database that contains an up-to-date list of all notified bodies in the EU. NANDO provides detailed information about the scope of each body’s designation and the legislation for which it is responsible. This transparency is crucial for manufacturers seeking a qualified notified body to assess the conformity of their products.

Importance for the European single market

The system of notified bodies and accreditation is a cornerstone of the European single market. It ensures that products placed on the market in one EU member state can circulate freely in all other member states. This promotes the free movement of goods while strengthening consumer confidence in the safety and quality of products.

Moreover, this system contributes to the international competitiveness of European companies. Conformity certificates issued by notified bodies are recognized in many third countries, facilitating exports of European products.