14 docs tagged with "classification"

MDR Annex VIII, Rules 9–13 and Rule 22 govern active device classification. MDR Annex I, GSPR §14–16 and §19–22 cover design requirements for active and energy-emitting devices.

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.

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.

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.

MDR 2017/745, Annex VIII. All 22 classification rules must be applied systematically. Where more than one rule applies, the highest resulting class prevails.

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.

IVDR Art. 2(7) (definition); IVDR Art. 48(3) (mandatory EMA/NCA consultation); IVDR Annex VIII Rule 2 (Class C minimum for companion diagnostics). Companion diagnostics require mandatory coordination between the IVDR pathway and the pharmaceutical regulatory pathway.

MDR Annex VIII Rule 14 (classification); MDR Art. 1(8)–(9) (drug-device combination products); MDR Annex I §8 (GSPR). Integral drug-device combinations where the device action is principal are Class III under MDR and require EMA or NCA consultation.

MDR Annex VIII Rules 17–18 (classification); MDR Annex I §13 (GSPR); EN ISO 22442 series (animal tissue requirements); European Pharmacopoeia Chapter 5.2.8 (TSE risk minimisation). Devices made from non-viable human tissue are Class III; non-viable animal tissue devices are also Class III (with some Class IIb exceptions).

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.

MDR Art. 2(5) (definition); MDR Annex VIII Rule 8 (classification); MDR Art. 18 and Annex XV §2.12 (implant card); MDR Annex I §22–23 (GSPR for implantables). Active implantable devices are governed by the same regulation (AIMDs are now Class III under MDR).

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).

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.

MDR Art. 2(1) (software included in definition); MDR Annex VIII Rule 11 (classification); MDR Annex I §17 and §21 (GSPR for software). MDCG 2019-11 and MDCG 2021-24 provide detailed guidance. For IVD software: IVDR Annex VIII Rules 1–7.