Members exclusive access

Transatlantic Trade and Investment Partnership (TTIP) initial position paper on Medical Devices

date 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

2018-06-29T11:19:26+00:00