How classification works
MDR classification rules are in Annex VIII of MDR 2017/745. IVDR classification rules are in Annex VIII of IVDR 2017/746. Classification determines the conformity assessment route, notified body involvement, and post-market obligations.
Class I · IIa · IIb · III
MDR 2017/745, Article 51 and Annex VIII. MDR uses a four-class system with Class I subdivided into sub-classes based on sterility, measuring function, and reusable surgical instrument status.
Classification rules 1–22
MDR 2017/745, Annex VIII. All 22 classification rules must be applied systematically. Where more than one rule applies, the highest resulting class prevails.
Class A · B · C · D
IVDR 2017/746, Article 47 and Annex VIII. IVDR replaced the old IVDD framework (List A / List B / General Devices) with a risk-based four-class system reflecting the risk posed by the diagnostic information generated.
Classification rules 1–7
IVDR 2017/746, Annex VIII. Seven rules classify IVDs based on the risk posed by the diagnostic information they generate, the severity of conditions they detect, and the vulnerability of the populations they serve.
Software & SaMD classification
MDR software classification is governed by Annex VIII, Rule 11 of MDR 2017/745. IVDR software follows the same class assignment rules as other IVDs under IVDR Annex VIII. MDCG 2021-24 provides authoritative guidance on MDR Rule 11 application.
Borderline & combination products
Borderline product guidance is primarily in MDCG 2022-5. Drug-device combinations are addressed in MDR Art. 1(8)–(9), MDR Annex I §12.2, and relevant EMA guidance. ATMP combination products are governed by Regulation (EC) No 1394/2007.
Reclassification & SCENIHR opinions
MDR Art. 51(2) and IVDR Art. 47(2) empower the European Commission to reclassify devices or device categories by implementing act. Scientific opinions informing reclassification were historically provided by SCENIHR (now replaced by SAG-MD and the MDCG).