Compliance is not certification

A confusion that appears in almost every early-stage robotics company I review: treating compliance and certification as the same thing.

"We comply with ISO 13849" means the company followed the standard's requirements during development and self-declares that the product meets them. This is a statement made by the manufacturer. No external party has verified it. The manufacturer writes a Declaration of Conformity, applies the CE mark, and places the product on the market.

"We're certified to ISO 13849" means an independent third party — a certification body like TÜV, UL, or Pilz — assessed the product, reviewed the safety analysis, examined the design documentation, and confirmed that the requirements are met. This is evidence, not a statement.

Both have legal standing. Both allow you to sell in the EU. But they carry very different weight when something goes wrong. A self-declared compliance statement is the manufacturer's word. A certification report is an independent assessment. In a liability dispute, the difference matters.

The EU Machinery Regulation 2023/1230 changes the equation for a specific category of machines. Under the old Machinery Directive 2006/42/EC, most machines could be self-certified by the manufacturer. Only a narrow list in Annex IV required third-party assessment. Under the new regulation, Article 25 and Annex I Part A define categories of high-risk machines that now require notified body involvement. This includes machines with AI-based safety functions.

For any robotics company building machines that use AI in their safety-related control systems — and selling into Europe after 20 January 2027 — self-declaration is no longer sufficient. A notified body must be involved in the conformity assessment process.

The practical implication: if your compliance strategy today is "we follow ISO 13849 and self-declare," you need to ask whether your product falls into the Annex I Part A categories. If it does, January 2027 means you need a notified body. That's a budget line item, a timeline addition, and a relationship you should be building now — not in December 2026.