DEKRA Certification obtains official approval of European Commission

DEKRA Becomes First Notified Body in Europe for In-Vitro Diagnostics under New IVD Regulation

Oct 15, 2019

DEKRA has become the first certification company to be recognized as a Notified Body by the European Commission under the new EU regulation on in-vitro diagnostics. Under this new regulation, considerably stricter requirements will apply to manufacturers of in-vitro diagnostics (IVDs) in the European Union starting from May 26, 2022. IVDs are medical products for laboratory testing of human samples.

DEKRA Certification GmbH, based in Stuttgart, is now the first company to be listed in the European Commission’s NANDO database in accordance with EU Regulation (EU) 2017/746 on in-vitro diagnostics. The regulation came into force in 2017 and will apply on May 26, 2022. The procedure to be approved as a Notified Body is extremely complex and took around two years.
In the new Regulation (EU) 2017/746, the provisions on EU market access have been made considerably stricter. Several products for which a self-declaration was previously sufficient will require approval by a Notified Body from 2022 onward. There are also stricter rules on documentation, clinical evaluation and monitoring.
In August 2019, DEKRA Certification already became one of the first testing, inspection and certification companies to be appointed as a Notified Body under the new Medical Devices Regulation (EU) 2017/745. This regulation introducing stricter requirements for medical devices will already apply on May 26, 2020.