Conformity Assessment Routes Under EU MDR: Which Path Applies to Your Device

Choosing your route before you choose your Notified Body

The conformity assessment route is not a choice you make — it is set by your device's classification and, in some cases, by the device type. What you do choose is how to navigate it: which Notified Body, which specific module within the route, and how much of the audit scope falls on your QMS versus your technical documentation. Getting clear on this early shapes every subsequent decision about timelines, resources, and NB engagement.

Class I devices without special characteristics sit entirely outside Notified Body involvement. The manufacturer self-certifies — meaning you issue a Declaration of Conformity on the basis of your own assessment that the device meets all applicable General Safety and Performance Requirements. There is no NB audit, no NB certificate. What this does not mean is that there is no work: the technical documentation still needs to be complete, the risk management file still needs to be in order, and a qualified person still needs to sign. Self-certification is a process, not a shortcut.

The moment a Class I device has a measuring function (think thermometers, spirometers, glucose monitors where the reading is clinically relied upon), is placed on the market in sterile condition, or is classified as a reusable surgical instrument, it enters a partially NB-involved route. For these devices, the NB reviews only the specific aspects that triggered the involvement — the measurement accuracy, the sterility validation, or the reprocessing instructions — and issues a certificate for those elements only. The rest of the conformity assessment remains with the manufacturer. This split is something teams often underestimate: you still carry the full burden for everything outside the NB's scope.

For Class IIa, IIb, and III devices, the main routes are:

Annex IX — QMS plus technical documentation review. This is the most common route for manufacturers with an established ISO 13485 QMS. The NB audits your full quality management system under the MDR-specific scope of Annex IX, then performs technical documentation assessment on at least one representative device from each generic device group. For Class III and implantable Class IIb devices, a full technical documentation review (not just a representative sample) is required. The advantage of Annex IX is continuity — once your QMS is certified, subsequent devices can be added more efficiently. The disadvantage is that the QMS audit scope under MDR is significantly broader than under MDD, and many manufacturers are surprised by the depth of clinical and PMS evidence that is now assessed at QMS level.

Annex X (EU Type Examination) + Annex XI — Type examination followed by either production quality assurance (Part A of Annex XI) or product verification (Part B). This route is used where Annex IX is not applicable or not offered by the NB for the device type, and for certain Class III devices where the regulation specifies type examination. The NB examines a representative sample of the device — design, manufacturing, performance — and issues an EU Type Examination Certificate. The manufacturer then operates either a QMS (Annex XI Part A) or submits individual batches for verification (Annex XI Part B). Type examination can also run in parallel with Annex IX for complex or high-risk devices.

One thing that catches teams off guard: not every NB offers every route for every device type. A NB's designation covers specific device codes (MDN codes), and if your device code falls outside their designation scope, they cannot certify it regardless of their overall capacity or reputation. Always verify the designation scope before approaching a NB — the NANDO database is the definitive source. Finding out late that your chosen NB cannot cover your device type is a timeline hit you do not want.

The conformity assessment route also interacts with your transition planning if you are moving from MDD. Legacy MDD certificates issued under Annex II, IV, V, VI of the old directive map roughly — but not cleanly — onto the MDR routes. The NB holding your MDD certificate is likely to be your starting point for MDR certification, but the applicable MDR route will be determined by your device's MDR classification, not by the MDD route you were previously on. Devices that moved class under MDR — particularly some software, active therapeutic devices, and devices incorporating substances — may find themselves on a more demanding route than they were under MDD.