How do I choose a Notified Body, given the backlog?

In short: Choose a Notified Body designated for your device codes, with software and AI experience, realistic lead times, and language fit. Capacity is the binding constraint: backlogs commonly cited in the 6 to 12-plus month range for an initial application slot alone are typical, so approach candidates early — before your documentation is finished — and treat the application slot as part of your critical path.

What to check before you apply

Not every Notified Body is designated for every device code, so the first filter is confirming your candidates are actually scoped for your product type. After that, experience matters more than size: a Notified Body with a track record reviewing standalone software and AI-containing devices will ask sharper, more relevant questions than one whose caseload is mostly hardware. Ask directly about current lead times for an initial application slot, not just certification timelines once work begins — the two numbers are often very different, and the first one is what actually determines your start date.

Why timing is the real decision

Notified Body capacity, not your own documentation speed, is usually the binding constraint on your overall CE-marking timeline. An application-slot wait in the 6 to 12-plus month range, before substantive review even starts, is commonly cited across the system. That means the sequencing most founders get wrong is waiting until the technical file is "finished" before approaching a Notified Body — by the time you're ready to submit, you could already be months into a queue you hadn't joined yet.

What this looks like in practice

Approach two or three candidates in parallel once you have a confident classification and a rough technical-file outline, even if the file itself is months from complete. Ask each for a realistic slot date, not an aspirational one, and treat whichever slot you can actually secure as a hard date your internal QMS and clinical-evaluation work now needs to hit — not the other way around.

Where next: MDR Annex VIII: How Device Classes Are Set · Do I need a Notified Body?

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