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Do I need a Notified Body?

The single most expensive question in CE marking. Select the EU regulations that apply to your product and answer a question or two — this tool tells you, per regulation, whether a Notified Body is mandatory and which conformity-assessment modules you can use. Deterministic, sourced to each Annex and Article.

Which EU regulations apply to your product?

Not sure? Run the Directive Selector first.

Why not just ask a chatbot?

  • The routing rules are deterministic and sourced — each outcome cites the exact module, Annex and Article. A chatbot blends directives together and gets the “self-assess vs Notified Body” line wrong, which is a five-figure mistake.
  • It encodes the real distinctions — RED’s harmonised-standards condition, the CRA Class I vs Class II cliff edge, MDR’s class ladder — that a general model flattens or hallucinates.
  • Curated by Inovasense engineers who take their own products through these exact routes.

It is the same discipline behind the product: Cenitia drafts compliance documents against the retrieved text of each regulation and your own engineering files, cites every claim, scores each section 0–1, and holds anything under 0.95 for human review before you sign — so a regulator never has to take “the AI said so” on trust. See how the engine works.

FAQ

Questions about this tool

  • Does this tell me definitively whether I need a Notified Body?+

    It gives a per-regulation indication based on the options you select — whether a Notified Body is required, optional, or not needed, and which conformity-assessment modules apply. The definitive answer depends on your product’s full specifics and the route you choose, so treat it as orientation, not legal advice.

  • Does my data leave my browser?+

    No. The checker runs entirely in your browser — your selections are evaluated on your own device and nothing is sent to a server or stored. No login is required.

  • What is a Notified Body?+

    A Notified Body is an independent organisation designated by an EU member state to carry out third-party conformity assessment for certain higher-risk products before they can be CE-marked. You can look up designated bodies and their scopes in the EU’s NANDO database.

  • Which regulations does it cover?+

    The EU regulations where the Notified Body question actually arises for hardware — RED, the Cyber Resilience Act, MDR, the Machinery Regulation, EMC, the Low Voltage Directive, RoHS and the GPSR — each evaluated against its own conformity-assessment routes.

Related: When you need a Notified Body · Conformity assessment modules A–H · Notified Body in the glossary

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The EU compliance engine for hardware manufacturers. Cited drafts, electronic signing, regulation watching — all in one place.

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