First NB designation under the IVDR

DEKRA Certification GmbH in Germany (DEKRA) is the first Notified Body officially designated for the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR).

The exact scope of DEKRA’s designation can be accessed via the European Commission’s NANDO database . In short, they have been designated for almost all codes and can certify conformity assessments based on a quality management system and on assessment of technical documentation (Annex IX). DEKRA’s scope does not cover conformity assessment based on type-examination (Annex X) and on production quality assurance (Annex XI).