News about GMP/cGMP


MDR: Norwegian DNV GL Presafe AS is 10th Notified Body

The Norwegian DNV GL Presafe AS (Notified Body 2460) is now a Notified Body for EU Medical Devices Regulation (MDR) 2017/745.

The company was added to the NANDO database operated by the European Commission. Another 20 MDR and IVDR designations are planned to be achieved by the end of the first quarter of 2020. DNV GL also plans to apply for designation under Regulation (EU) 2017/746 (IVDR). Just three NBs have been designated under IVDR so far.



MDR and IVDR Implementing Measures: Rolling Plan


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