PLATE 05 OF 20
Conformity assessment.
Which assessment route applies, and what each route requires from the manufacturer and any notified body.
Pillar guide
Machinery conformity assessment: choosing the route: Under the Regulation, Article 25 connects the product category and standards coverage to the available assessment procedures.
Supporting guides
| Guide | What it covers |
|---|---|
| Annex I Part A categories and routes | Categories in Part A, and the three notified body routes Article 25(2) provides for them. |
| Annex I Part B categories and the standards condition | Part B allows internal production control only where category specific standards or specifications cover all relevant requirements. |
| Machinery outside Annex I | Module A internal production control for machinery whose category is not listed, and what the manufacturer still owes. |
| EU type examination, module B | What type examination examines, and how it connects to the later conformity to type step. |
| Full quality assurance, module H | A quality system route that still needs product evidence, and what the notified body assesses. |
| Unit verification, module G | A route for a single unit, and when it fits better than a type based route. |
| Internal production control, module A | The manufacturer internal route, and the discipline it still requires in assessment and documentation. |
| Checking notified body scope in NANDO | Confirming a notified body is designated for the product and procedure before relying on its involvement. |
| Directive assessment routes under Article 12 | The current Directive routes, kept separate from Regulation routes while the Directive still applies. |
| Using an assessment route selector | A selector that explains ordinary routes, and the limits that keep it from classifying a product or deciding scope. |
| When the conformity route changes | Design, standards, or category changes that move a product between routes, and how to handle the move. |
| Linking assessment to evidence | How the chosen route shows up in the technical file, the declaration, and the marking, as one traceable chain. |