Design & Manufacturing Information (IVDR)

IVDR reference: Annex II, Section 3
BPG reference: Team-NB BPG-IVDR V2 (approx. pp. 13–14)
Document code: AII-S3

Sites and critical outsourced parties

[ ] Name/address of critical outsourced production/services and related certificates
[ ] Where critical subcontractors/suppliers lack a valid NB QMS certificate: satisfactory evidence for the NB (e.g. additional supplier audits)
[ ] Evidence that purchased critical products/services meet specified requirements (e.g. EN ISO 13485 certificates, inspection/release records, agreements)
[ ] Sites and subcontractors included in the application; NB assesses need for on-site audit
[ ] Description of purchasing controls and controlled procedures

[ ] Description of design stages sufficient to understand how design is applied to the device
[ ] Design inputs/outputs, reviews, verification and validation evidence chain (or controlled QMS references)
[ ] Design change control: assessment of new hazards / impact on performance evaluation
[ ] Software design lifecycle references where applicable

[ ] Manufacturing process overview (critical steps, process controls, special processes)
[ ] Sterilisation (if applicable): method, validation status, sterile barrier system
[ ] Batch release criteria and critical QC
[ ] Clear interface to labelling/packaging processes