Navigating EU MDR 2017/745 & US FDA 510(k) for Overseas Medical Disposable Tenders

Authored by: Global Regulatory Affairs Desk

"An essential regulatory roadmap for international health ministry procurement officers, covering technical dossiers, UDI labeling, and Post-Market Surveillance."

1. EU MDR 2017/745 Technical Dossier Requirements

The European Medical Device Regulation (EU MDR) requires stringent clinical evaluation reports (CER), biocompatibility cytotoxicity testing according to ISO 10993, and rigorous risk management matrices under ISO 14971. AI Dispo maintains certified Class IIa and Class IIb technical documentation dossiers.

2. Unique Device Identification (UDI) & GS1 Barcodes

Every medical consumable carton and blister pack manufactured by AI Dispo carries machine-readable GS1 DataMatrix UDI barcodes containing device identifier (UDI-DI) and production identifier (UDI-PI), ensuring complete track-and-trace throughout hospital supply chains.

3. Health Ministry Tender Documentation & Audit Readability

We provide complete tender submission dossiers including Free Sale Certificates (FSC), Certificate of Pharmaceutical Product (COPP), WHO-GMP certifications, and batch Certificate of Analysis (COA) for rapid ministry approval across 45+ export nations.

Keywords:#CE MDR Certified#US FDA 510k#Medical Device Export#WHO-GMP

Need Full Technical Dossier & Samples?

Request batch test certificates, COA, and export price books.

Request Regulatory Dossier