Article 52 leaves the assessment route to the manufacturer

Getting to a CE mark reads, from outside the file, like one fixed process: submit to a notified body, pass an audit, receive a certificate. For most of the device classes MDR 2017/745 covers, that's close enough to true — the class decides the route and nobody has to choose one. Article 52 breaks that pattern for two specific groups: Class III devices other than custom-made or investigational ones, and Class IIb implantable devices outside a short named list of excepted product types. For those manufacturers, the regulation hands over an actual election between two structurally different conformity assessment procedures, and picking one sets the shape of a working relationship with a notified body for as long as the device stays certified — not a formality that resolves itself once the class is known.

Annex IX bundles the system and the file into one relationship

Article 52(1) makes Annex IX the default for the Class III devices it covers: a conformity assessment based on a quality management system audit under the annex's Section 3, combined with an assessment of the technical documentation under Section 4, examined in full for the highest-risk devices. The two pieces run through the same notified body as one ongoing engagement — a single certificate, a single audit cycle, surveillance visits that touch both the system and the file together. Most manufacturers that have a choice default here, because a single relationship covering both halves of conformity is administratively simpler to plan around than two.

Annex X plus XI separates the type from the batch

The alternative Article 52 names is Annex X coupled with Annex XI, and it isn't a lighter version of Annex IX — it's a different structure entirely. Annex X is type-examination: a notified body examines a representative sample of the device, the “type,” and confirms the design and technical documentation conform to the Regulation's requirements. Annex XI is a separate assessment of production — Part A, quality assurance of the production process itself, or Part B, verification of the manufactured product against the examined type — and it runs independently of the design examination Annex X already completed. A manufacturer on this route is carrying two distinct assessment streams, potentially timed differently, rather than one integrated audit.

The regulation names both paths and lets the manufacturer pick

For the Class III devices Article 52(1) covers, and separately for the Class IIb implantable devices Article 52(4) covers — outside the excepted list of sutures, staples, dental fillings, and similar low-complexity implantables, where Annex IX's technical-documentation assessment applies to every device regardless — the choice sits with the manufacturer, not with FDA-style classification tables that fix the pathway to the device type. That's a genuinely different model from the 510(k) pathway fork this blog has already covered on the US side, where the device's own history decides which route is even available. Here, both routes are available to the same device, and the manufacturer's own production model — a centralized quality system built for ongoing audit, or a manufacturing process better suited to per-batch verification — is what should be deciding which one it elects, not administrative habit.

The route chosen has to show up correctly downstream

Whichever path a manufacturer elects, the choice doesn't stay contained inside the conformity assessment file. The EU declaration of conformity this blog has already covered has to name the notified body involved and reference its certificate under Annex IV, and a declaration built once and copied forward can drift out of sync with which annex route, and which certificate, actually backs it — particularly if a manufacturer changes route at recertification. The technical documentation the assessment reviews in the first place is the same file a GSPR checklist has to trace hazard by hazard; a route switch doesn't change what that checklist has to show, only who is reviewing it and on what cycle.

Where this meets the file

A conformity-route memo that documents which of Article 52's paths a device uses, why, and where that choice is reflected in the declaration of conformity and the notified body's own certificate — rather than treating the route as a detail the notified body relationship settles informally — is previewed in the launch catalog. If your program elects differently across its own device families, the shelf takes that correction directly.