IVDR ties the assessment route to class, not a choice

MDR gives certain manufacturers a genuine election between conformity assessment routes, independent of what else the device's classification decides — this blog has already covered that choice under Article 52. IVDR's own conformity assessment article looks similar on the surface, naming the same three annexes, but it hands that kind of choice to a much narrower slice of the devices it covers. For most IVDR risk classes, Article 48 doesn't ask a manufacturer to elect anything — the class itself fixes the route, and the only real decision left is whether the device actually belongs in the class a manufacturer has assigned it to.

Class A mostly self-declares, with one carved-out exception

A non-sterile Class A device under Article 48(1) never reaches a notified body at all: the manufacturer draws up the technical documentation Annex II and III require, issues its own EU declaration of conformity, and moves on. That's the same self-certification logic this blog has already covered as IVDR's classification default working itself out downstream in the assessment article — but the exception matters as much as the rule. A Class A device that's sterile, or that has a measuring function, still needs a notified body involved for that one aspect specifically; the rest of the file stays self-declared. A manufacturer that reads ‘Class A, no notified body’ as a blanket rule has missed the narrower carve-out sitting inside its own class.

Class B has one route, not a menu

Class B devices don't get an election at all. Article 48 routes them through Annex IX — a notified body audit of the quality management system, paired with an assessment of technical documentation on a representative, per-category basis rather than a full review of every device's own file. There's no alternative annex combination sitting beside Annex IX for a Class B manufacturer to weigh; the class decides the path, full stop, and the only judgment call left is making sure the technical documentation a notified body actually samples is representative of the category it's drawn from, not just the specific device a manufacturer expects to get picked.

Class C and D are where a real choice shows up

The election IVDR does offer arrives at the top of the risk scale, and it mirrors MDR's own Article 52 mechanism closely: manufacturers of Class C devices, other than devices for performance study, may apply Annex IX in full, or elect Annex X type-examination coupled with Annex XI production quality assurance — with Annex XI's Section 5 excluded from that combination for Class C specifically. Class D manufacturers get the same structural choice between Annex IX and Annex X paired with Annex XI, without that Section 5 exclusion. In both cases the underlying logic is the one this blog has already traced on the MDR side: Annex IX bundles the quality system and the technical file into one ongoing relationship, while Annex X plus XI separates a one-time design examination from an independently run production assessment.

Class D adds a check no MDR device carries

Class D layers in something IVDR built specifically for its own highest-risk tier: verification by an EU reference laboratory designated under Article 100, which checks the manufacturer's own performance claims and, for certain devices, tests batches before they reach the market. That obligation sits inside Annex IX and Annex XI's own text for Class D specifically — it isn't a general notified-body power available at the manufacturer's request, and it has no real counterpart in MDR's own conformity assessment structure for implantables or Class III devices. A Class D manufacturer that plans its assessment route around Annex IX or Annex X/XI alone, without accounting for a reference laboratory step neither annex fully describes on its own, has priced the easier half of what Class D actually requires.

Where this meets the file

The class a device carries isn't just an input to which GSPRs and PMPF obligations it owes — under Article 48 it's the decision that removes the assessment-route question entirely for most manufacturers, and only reopens it as a real election at the top two classes. A conformity-route memo that documents which class a device sits in, which annex combination Article 48 actually allows for that class, and whether a reference-laboratory step applies, is previewed in the launch catalog. If your program routes a device differently, the shelf takes that correction directly.