The objective is to promote regulatory convergence in the medical devices sector.
This could cover:
• Recognition of manufacturers’ quality management systems (QMS) audits
• Convergence of systems for identifying and tracing medical devices (Unique Device Identification – UDI)
• Convergence of models for marketing submissions (Regulated Product Submission – RPS)
Namely the possible elements for a medical devices annex in TTIP are :
1. Quality Management System Audits
2. Unique Device Identification (UDI) and interoperability of databases
3. Harmonised template for data submission (Regulated Product Submission – RPS) and a common/interoperable system for electronic data submission
4. Exchange of confidential information and trade secret information
5. Reinforce cooperation in IMDRF
6. Reinforce bilateral regulatory cooperation in new areas