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).
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.