MDR implementation update and timeline

Update on the process

CAMD Roadmap actions on the MDR Implementation

  • 51 actions: work in progress and will be published soon
  • 49 actions: leader has been identified
  • 69 actions: no leader/working group identified, no planning

Implementing Acts:

  • 3 published
  • 77 to be published (Reprocessing of devices coming soon)

Common Specifications for Annex XVI devices (devices without a medical purpose) will be published after May 2020 – allowing manufacturers a 6-month transition;

MDCG shall issue another 48 Guidance documents

NB Designation:

  • 86% of MDD NB and 50% of IVDD NB applied under the new Regulations;
  • Designation process takes 1 year and 7 months before NB appears on NANDO;
  • 18 NBs expected by Q1 2020.

Expert panels: 700 applicants so far;

Few clarifications


  • Basic-UDI and UDI-DI assignment mandatory from May 2020!


  • No link between SRN and UDI (except for the future linkage in EUDAMED);
  • On a voluntary basis manufacturer shall be able to request it in March/April 2020;

Grace period: custom-made devices are not included in the 2nd Corrigendum;

EUDAMED: until full operationality, national notification/registration to the Competent Authority will continue;

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