Medical devices and in-vitro diagnostics run on two different EU regulations, with different risk classes and different routes to a CE mark. Knowing which one you're in — and your exact class — is the first decision, because it determines everything downstream.
If your product acts on or in the body, it's a medical device under MDR (EU 2017/745), classified I / IIa / IIb / III. If it examines samples taken from the body — blood, tissue, DNA — it's an in-vitro diagnostic under IVDR (EU 2017/746), classified A / B / C / D. The two regimes share a CE-marking logic but differ on classification, evidence and — critically — when a Notified Body must be involved. The IVDR reclassification, in particular, pulled most diagnostics into Notified-Body routes for the first time.
Before route, evidence, timeline or cost, one question sets the whole path: which regulation governs your product, and at what class?
MDR and IVDR are not interchangeable. They cover different products, use different classification systems, and demand different clinical or performance evidence. Get the regime or the class wrong and the entire conformity plan is built on the wrong foundation — a mistake that surfaces late and costs time you can't recover.
Your regime and class isn't paperwork. It's the decision every other decision hangs from.
The green cells are the classes that require a Notified Body (Benannte Stelle) conformity assessment. The pale cells can be self-declared.
Same CE-marking philosophy, different mechanics — and a very different share of products that now need external assessment. We keep devices and diagnostics on separate tracks for exactly this reason.
Both regimes classify by rules, not by product name. You apply the classification rules in the regulation's annex to your device's intended purpose, duration of use, invasiveness and the risk it carries.
The intended purpose you write is decisive: a small wording change can move a product up or down a class, and with it the whole evidence and Notified-Body burden.
Your regime and class set the conformity route, the evidence you must generate, the timeline and the cost — and they shape what comes after the CE mark, too. Because a CE mark still isn't reimbursement: how a device or diagnostic gets paid for in Germany runs on a separate system entirely.
Regime and class get you the CE mark. Reimbursement is the next, separate project.
In a focused session we pin down MDR vs IVDR and your exact class, the realistic CE timeline (Notified-Body bottleneck included), and the reimbursement route that fits — so authorization and market access aren't two disconnected projects.