Information Supplied by Manufacturer (IVDR)

IVDR reference: Art. 10(10), Annex I GSPR 20, Art. 18; DoC Art. 17 / Annex IV
BPG reference: Team-NB BPG-IVDR V2 (approx. pp. 11–12)
Document code: AII-S2

General

• [ ] Each device is accompanied by information needed to identify the device and manufacturer and by safety/performance information for the user (on device, packaging or IFU)
• [ ] If the manufacturer has a website, information is available and kept up to date (Art. 10(10))

Labelling

• [ ] Final approved labels for all variants and applicable packaging levels (device, sterile, unit, sales, transport)
• [ ] Legible finished-form labels showing all symbols
• [ ] Packaging configuration drawings (label placement) and label specifications where possible
• [ ] Clear label positions; sterile-pack labels identified
• [ ] User information printed on packaging provided
• [ ] Label content verified per GSPR 20.2 and Art. 18
• [ ] Harmonised standards / CS labelling requirements addressed
• [ ] Dangerous substances/mixtures: CLP pictograms/labelling ((EC) No 1272/2008)
• [ ] Extra particulars for sterile packaging; self-testing and near-patient testing labels
• [ ] Class C/D: where SSP is available stated on label or IFU (Art. 29; without full EUDAMED)

Instructions for use / manuals

• [ ] IFU in the language required by the NB assessing conformity
• [ ] TD lists intended sales countries and summarises translation process
• [ ] IFU intended purpose / indications / contraindications / warnings aligned with RM, performance evaluation and usability
• [ ] IFU contains all applicable GSPR 20.4 and Art. 18 information
• [ ] Standards/CS-specific IFU requirements addressed
• [ ] Instruments: user, installation and service manuals where applicable
• [ ] Surveillance: list of countries sold + all translated labelling/IFU
• [ ] Self-testing IFU: additional information and lay-user validation

e-IFU, SDS, promotional materials, DoC

• [ ] e-IFU: electronic labelling information on device/leaflet + RM reference
• [ ] SDS (if provided) in TD with required translations; how to obtain SDS on label/IFU; REACH/CLP apply unless fully covered in IFU
• [ ] Only CE-claim / CE-mark promotional materials required; claims consistent with IFU/TD
• [ ] EU DoC (Art. 17 / Annex IV minimum content) available and kept updated

Related standards

• EN ISO 15223; EN ISO 18113; EN ISO 20417

Related pages

• Device description
• SSP
• GSPR