Device Description & Specifications (IVDR)
IVDR reference: Annex II, Section 1
BPG reference: Team-NB BPG-IVDR V2 (2025-09-03), Device Description & Specifications (approx. pp. 7–10)
Document code: AII-S1
Owner: Manufacturer
Service mode: Assisted (Reguverse: mandatory before PE / GSPR)
Consistency rule
- [ ] Device name and intended purpose/use are consistent across TD, IFU, labels, performance evaluation, risk management and promotional materials
- [ ] Any unavoidable differences are explained in the main technical document
- [ ] Device name/language matches the application form
1.1 Device description and specification details
(a) Name, general description, intended purpose / users
- [ ] Device or trade name and general description including intended purpose
- [ ] Table of each variant/model/configuration/component/accessory in scope with identifiers and descriptions
- [ ] EMDN code details
- [ ] Applicable IVDR NANDO codes ((EU) 2017/2185); single-use / multiple-use
- [ ] Description sufficient to understand design, packaging, sterilisation, combination use, components and accessories
- [ ] Companion diagnostics: associated medicinal product(s) with INN; note EMA centralised vs national CA procedure
- [ ] Intended purpose detailed enough for IVDR Article 2 medical purpose
- [ ] Intended users (lab professionals / HCPs / lay persons) substantiated by clinical performance evaluation, RM and usability
(b) Basic UDI-DI
- [ ] Basic UDI-DI per Annex VI Part C
- [ ] Consistency across the full TD
- [ ] Devices under one Basic UDI-DI: differences and grouping rationale (MDCG 2018-1)
(c) Intended purpose elements (Annex II 1.1(c))
- [ ] (i) what is detected and/or measured
- [ ] (ii) function (screening, monitoring, diagnosis, aid to diagnosis, prognosis, prediction, CDx, …)
- [ ] (iii) disorder, condition or risk factor of interest
- [ ] (iv) automated or not
- [ ] (v) qualitative / semi-quantitative / quantitative
- [ ] (vi) specimen type(s)
- [ ] (vii) testing population where applicable
- [ ] (viii) intended user
- [ ] (ix) for CDx: target population and associated medicinal product(s) including INN
- [ ] Intended testing population documented; if unrestricted, include IFU limitations against foreseeable misuse
- [ ] Intended-use changes reviewed for impact across the file
- [ ] User and use environment supported by clinical performance evaluation
(d)–(f) Principle, qualification, classification
- [ ] Detailed assay method principle or instrument operating principle
- [ ] Qualification as an IVD under Article 2 (software borderline: MDCG 2019-11)
- [ ] Exclusions addressed (general lab / RUO, invasive sampling devices, certified reference materials / EQA materials); specimen receptacles are IVDs
- [ ] Class A/B/C/D with Annex VIII rule-by-rule rationale; strictest rule wins; N/A rules explained; multi-analyte: classify each, highest applies overall (MDCG 2020-16)
(g)–(m) Components, novelty, combination, specimens, instruments, software, configurations, accessories
- [ ] Components and reactive ingredients (antibodies, antigens, primers, …) as applicable
- [ ] Novel features and impact on safety/performance, or explicit “no novel features”
- [ ] Combination use and compatibility evidence
- [ ] Specimen collection/transport materials and pre-analytical requirements
- [ ] Instrument compatibility (part of performance evaluation) and instrument characteristics table where automated
- [ ] Software used with the device and versioning
- [ ] Complete list of configurations/variants to be placed on the market
- [ ] Accessories and non-device products; MDR accessories: certificate/DoC
1.2 Previous generations and similar devices
- [ ] Previous generations overview
- [ ] IVDD legacy (self-declaration and/or NB certificate) and changes vs IVDD-certified version
- [ ] Market history (EU and other regions); totally new devices stated explicitly
- [ ] Similar devices overview with key specification comparison where available
Common NB gaps
- Incomplete intended-purpose elements vs IFU / performance evaluation
- Variant / accessory / UDI / DoC / label inconsistencies
- Missing IVDD→IVDR change history
- Classification conclusion without non-applicable-rule reasoning