Under the EU Medical Device Regulation, everything starts with classification. Get the risk class right and the whole route to market follows logically; get it wrong and you build your entire compliance strategy on the wrong foundation.
The MDR (Regulation (EU) 2017/745) sorts devices into four risk classes — Class I (lowest risk), IIa, IIb and III (highest). Class I has three sub-categories: Is (sterile), Im (measuring function) and Ir (reusable surgical instruments).
Rule-based, and driven by intended purpose
Classification is not a matter of opinion — it follows the 22 rules of Annex VIII, grouped into non-invasive devices (Rules 1–4), invasive devices (Rules 5–8), active devices (Rules 9–13) and special rules (Rules 14–22). The determining factor is the device’s intended purpose, together with duration of contact, degree of invasiveness and whether the device is active. Where several rules apply, the highest resulting class governs.
The up-classification effect
Compared with the old Medical Device Directive, the MDR pushed many products into higher classes. Reusable surgical instruments now need notified body involvement for the reusable aspect, and a range of substance-based and software products moved up. Manufacturers who assumed their legacy classification still held have often been caught out.
Rule 11: the software trap
Software is the single biggest driver of up-classification. Under Rule 11, software that provides information used for diagnostic or therapeutic decisions is Class IIa — rising to IIb where a wrong decision could cause serious deterioration of health or surgical intervention, and Class III where it could cause death or irreversible deterioration. Much software that self-certified under the old rules now needs a notified body.
Class decides the route
Only Class I (non-sterile, non-measuring, non-reusable-surgical) is self-declared with no notified body. Every higher class — including Is, Im and Ir — requires notified body involvement. Classification is therefore the decision that determines cost, timeline and evidence burden for everything that follows.
How PQRA helps
PQRA advises on device classification, intended-purpose definition and the conformity-assessment route best suited to your product.
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