Speech at IL3 (UB), November, 28th - 2017

From local serialization to global traceability: finding answers in the cloud.

The traceability of devices by means of a Unique Device Identification system (UDI system) based on international guidance should significantly enhance the effectiveness of the post-market safety-related activities for devices.
Transparency and adequate access to information, appropriately presented for the intended user, are essential in the public interest, to protect health, to empower patients and healthcare professionals and to enable then to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in the regulatory system.

Regulation (EU) 2017/45 of the European Parliament of the Council of 5 April 2017