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
UDI:
- Basic-UDI and UDI-DI assignment mandatory from May 2020!
SRN:
- 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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