Timeline MDR certification

Step 7:
Step 4:
Conformity
SIQ performs the
assessment
technical
Step 2: Step 6: procedure
documentation Step 5:
SIQ performs the SIQ performs a (Annex X, Annex
and clinical Organization
pre-check of post-audit and XI part B, Annex
evaluation submits
technical issues an audit XI part A, Annex
Step 3: assessment and Corrective action Step 8:
documentation report - IX,…)
Organization issues an audit report Notified body
Step 1: report
submits Commission
Organization
amended takes place, the
submits the
technical Depending on chosen decision on
technical 1-2 weeks 12-14 weeks up to 6 months 10-12 weeks
documentation* assessment route granting
documentation
certificate is
* in case of e.g. accepted;
missing Step 5 and 6 may be repeated in case EU certificate is
Annex IX, Annex XI part A –
documentation nonconformities are not resolved in Quality management granted
at pre-check first post-audit (additional timing) system – certification audit
stage 1, stage 2 (audit +
report – 8 weeks/stage) +
possible post audit (8
weeks/audit)