News about GMP/cGMP


German DEKRA listed as third Notified Body under new MDR

In addition to BSI UK and TÜV Süd, the German DEKRA Certification GmbH is now recognised as a third Notified Body for the EU Regulation 2017/745 (MDR).

This reference can be found on the information portal NANDO of the European Commission (New Approach Notified and Designated Organisations). By the end of 2019, 20 Notified Bodies shall be appointed. There is still no Notified Body listed for the IVDR.


MDR and IVDR Implementing Measures: Rolling Plan

European Commission: NANDO