Only 5 NB applied under MDR by mid-February

The European Commission received only five preliminary assessment reports from the “designating authorities” by February 12, 2018.

As previously discussed on this blogthe submission of the application dossier and the preliminary assessment report is the first step for a Notified Body (NB) to be appointed under the new MDR / IVDR.

As stated in the European Commission’s Information notice, the date of receipt functions as the main criterion in deciding on the order of joint assessments and their allocation to any next available on-site assessment date.

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