In-Vitro Diagnostic Devices (IVDR)
The new regulation of in-vitro devices focuses on a new classification of four risk classes, a more precise description of their clinical performance
As a medical device manufacturer, you must navigate your way through a complex landscape of regulatory requirements before you can sell your devices on the international market. International standards and European regulations are there to ensure that products are safe and function accordingly.
DEKRA is active almost everywhere in the world and the members of our medical device team have extensive expertise in a wide array of medical and in vitro devices.
In addition to being a designated European Notified Body, we are also a recognized MDSAP auditing organization. We offer all the essential services to manufacturers of medical devices: MDR, IVDR, IVDD, MDSAP and auditing for ISO 13485.
The FDA has approved DEKRA to take part in the Accreditation Scheme for Conformity Assessment (ASCA) pilot program. The ASCA program allows accredited, independent laboratories to assess premarket medical devices for compliance with FDA-recognized standards. By enhancing product reviewers’ and manufacturers’ confidence in testing results, the ASCA program decreases FDA requests for additional information on testing methodology. The end result is a more efficient review process and faster access to markets.