“State of the art” and the hierarchy of standards in PPE certification

When a notified body carries out an EU type-examination, it does not assess a product against a single standard in isolation. Regulation (EU) 2016/425 requires it to consider the “state of the art” — the body of recognised standards and technical specifications available at the time. Knowing what counts as state of the art, and in what order, helps a manufacturer anticipate what its certification will be judged against.

When does a change matter? A change in standards or specifications only obliges a notified body to act on certificates it has already issued when the change is “generally acknowledged.” In practice, that means the document is widely available to economic operators and notified bodies — freely, or through common purchase.

The hierarchy of documents. The notified bodies’ coordination has set out which sources count as state of the art. In summary:

• Harmonised standards — publicly available (typically via purchase); the primary reference.
• Recommendations for Use (RFUs) endorsed by the European Commission — the horizontal and vertical RFUs, freely available on the Commission’s PPE pages.
• Published European standards (CEN/CENELEC).
• RFUs approved by the Horizontal Committee but not yet Commission-endorsed — freely available on ppe-rfu.eu.
• Other national or international standards.
• Industry standards and technical specifications — often freely available.
• A private protocol developed by a notified body for a specific product (confidential to that manufacturer).

Draft documents — standard projects still under development (technical specifications, drafts, prENs) — are not to be considered as state of the art.

Why the Recommendations for Use matter. The RFUs are the notified bodies’ agreed interpretations of the Regulation and — as the hierarchy shows — are themselves part of the recognised state of the art. A notified body that helps write them applies the most current, harmonised reading of the rules.

How GÉPTESZT applies it. As an active member of the Horizontal Committee and the relevant Vertical Groups, GÉPTESZT contributes to and applies the latest RFUs. For a manufacturer, that means your product is assessed against a current, consistent, EU-wide interpretation — reducing the risk of surprises at market surveillance or in another Member State.

This article summarises the concept of “state of the art” and the hierarchy of recognised documents, drawing on Regulation (EU) 2016/425 (Annex V) and the notified bodies’ Recommendation for Use PPE-R 00.068.