Save 20% on accredited ISO 13485 course exams.
Limited-time offer – ends February 29, 2024
Use promo code:
EXAM20
Full text of EU MDR (Medical Device Regulation)
[simple-social-share css="0"]
EU MDR Chapter 8 Article 108

Article 108 – Device registers and databanks

The Commission and the Member States shall take all appropriate measures to encourage the establishment of registers and databanks for specific types of devices setting common principles to collect comparable information. Such registers and databanks shall contribute to the independent evaluation of the long-term safety and performance of devices, or the traceability of implantable devices, or all of such characteristics.

IMPLEMENT ISO 13485 & MDR
BY YOURSELF

SEE HOW IT WORKS

  • Optimized for small and medium-sized companies
  • Costs up to 80% less than using consultants
  • Expert consultations and unlimited email support available
  • Created by Advisera, the leading website for compliance