Table of Contents
EU MDD to MDR
Frequent made mistakes
Frequent mistakes when transiting from EU MDD to MDR
- Did not include UDI in EC DOC
- Did not include the reference to OTHER EU legislation like (Drugs, PPE, RoHS) in the same EU MDR DOC
- Using the same MDD conformity route annex reference instead of MDR conformity route annex reference.
- Not confirming whether providing electronic IFU ONLY is complying with MDR or not.
- Not following to Annex II technical documentations requirements EXACTLY
- Clinical Evaluation PLAN is missing
- PMCF plan & report or justification why PMCF is not needed is missing
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