Regulatory framework · Finished products
MDR: medical device compliance and supply chain
Qualify your MDR suppliers with solid regulatory evidence and keep critical components tracked through to audit.
Framework highlights
- MDR medical device questionnaire
- Qualified supplier files
- Traceability of critical medical-device components
In Suplylot
Questionnaires, grids and campaigns for MDR – medical devices
Ready-to-use templates in the buyer portal: supplier collection, automatic follow-ups and compliance tracking by reference.
- "MDR medical device collection" supplier questionnaire
- Medical device customer product assessment grid
- MDR campaigns on the strategic supplier panel
- QHSE register and audits integrated into supplier tracking
Regulatory framework
The MDR regulation (EU 2017/745) strengthens requirements on medical devices: classification, technical file, post-market surveillance and the responsibility of economic operators, including in the supply chain.
Purchases of medical-device components (sterile packaging, polymers, embedded electronics) must produce traceable evidence of supplier qualification and material compliance.
What the buyer must require
Evidence needs to be verifiable, dated and tied to a specific reference. A generic statement isn't enough.
- Supplier qualification based on component criticality (ISO 13485, audits).
- Biocompatible / sterile material declarations where applicable.
- Batch traceability and notified changes (change control).
- Quality agreements and MDR clauses in purchasing contracts.
Manage compliance over time
Suplylot links supplier qualification, MDR questionnaires and the QHSE register: non-conformities, CAPAs and audits feed into the partner score visible at quality committee meetings.
- Keep a material AVL separate from the general ISO 9001 list.
- Run MDR campaigns on tier-1 suppliers and upstream subcontractors.
- Prepare notified body audits with consolidated files.
Useful sources
Manage MDR – medical devices across your supplier panel
Questionnaires, document files and collection campaigns, from the material catalog to compliance tracking.
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