ELITechGroup S.p.A. receives IVDR certificate from DEKRA

DEKRA issues their first IVDR certificate

Feb 15, 2023

DEKRA Certification B.V. was pleased to issue their first certificate according to the In Vitro Diagnostic Devices Regulation (IVDR) EU 2017/746. ELITechGroup S.p.A. received the certificate on January 19, 2023.

The products certified under this first certificate are used to conduct testing to identify bacterial resistance to antibiotics. This allows doctors to determine the correct treatment options for patients. For example, the devices can be used for identifying Methicillin-resistant Staphylococcus aureus (MRSA).
The new IVDR legislation is significantly stricter than the previous In Vitro Diagnostic Directive (IVDD). It requires many more in-vitro diagnostic devices to undergo conformity assessment with a Notified Body than were previously required. Overall the certificate issued to ELITechGroup S.p.A. took approximately one and a half years, from start of the conformity assessment to issuance. This is a significant amount of time to certification. It serves the intention of the IVDR to ensure that products on the EU market meet the highest standards of safety and performance.
Visit our IVDR-page for more information about this topic.