Position Papers

DITTA White Paper on Unique Device Identification

Challenges with Implementing Global Unique Device Identification Requirements describes the current variability of unique device identification (UDI) requirements and implementation globally.

Challenges with Implementing Global Unique Device Identification Requirements describes the current variability of unique device identification (UDI) requirements and implementation globally.
This document describes some of these challenges and inconsistencies that industry has experienced as well as provides recommendations on improvements that can standardize and enable regulators implement global strategies which will improve adoption, usage and benefits of UDI requirements. , implementation and usage – in line with the expectations of the collaborative approach seen by the IMDRF working group and related documents.

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Cybersecurity

Clinical Evaluation

Medical Software & Artificial Intelligence

Digital health & cybersecurity

Good refurbishment practice

Environmental policy

Medical device single audit program

Standardisation

Unique Device Identification

Regulated Product Submission

Regulations & Standards

Global Health