Self-declaration is the rule
Self-declaration is the default for many categories at low to medium risk. The manufacturer performs the conformity assessment, prepares the technical file, issues the Declaration of Conformity, affixes the CE marking — and bears full responsibility for the call.
When a Notified Body is required
A Notified Body is required when the risk level is too high. This is product-specific. Medical devices from Class IIa. Certain toy categories per Annex V of the Toy Safety Directive. PPE Category III. Machinery Annex IV. Construction products at certain levels of essentiality.
Failure to clarify this at the start means meeting the Notified Body requirement just before market entry — when time and budget are already spent. Under MDR the Notified Body market has fundamentally changed. Increased requirements have driven several bodies out of medical devices. Remaining bodies have long waiting lists. To be on the market in two years, the Notified Body conversation starts today.
The decision must be made at the start of development — not at the end.
Excerpt from: Dr. Raphael Nagel — "Marktzulassung. How to bring your product to market in Switzerland and the EU — without recall, without liability, without detours." Tactical Management Press, 2026.