IVDR - Regulation of in vitro diagnostics
The safety and quality of In-vitro-Diagnostics (IVDs) is becoming increasingly important as consumers demand the highest safety standards from suppliers of products and services in the healthcare sector. In addition, international and European rules and regulations for in-vitro-diagnostics manufacturers are becoming increasingly complex and stringent.
The IVDR was officially published on 5 May 2017 and came into force on 26 May 2017. A transitional period of five years, until 26 May 2022, applies to manufacturers of already approved medical products in order to meet the requirements of the IVDR. The new regulation focuses on a new classification of IVDs into four risk classes, a more precise description of their analytical and clinical performance, more stringent requirements for the conduct of clinical trials, more precise execution and planning of post market surveillance, as well as better traceability of IVDs and more transparency for patients. Access for IVDs to the European market will be more stringent and the requirements for manufacturers, importers and distributors as well as notified bodies will be expanded and strengthened. The aim of the regulation is to ensure better protection of public health and patient safety.
Manufacturers of In-vitro-Diagnostics have a responsibility to keep patient safe. Therefore the manufacturers need to comply with European regulations to ensure that their innovative and continuously developed IVDs are safe and perform well. DEKRA is designated to review the conformity assessment to the European regulations for access to the EU market.
- DEKRA has two Notified Bodies for the EU In-vitro-Diagnostics Regulation (2017/746, IVDR): DEKRA Certification GmbH (NB 0124), which was in October 2019 the first designated Notified Body in Europe for the Regulation, and DEKRA Certification B.V. (NB 0344).
- With the combination of these Notified Bodies DEKRA is a reliable, competent partner for its customers in the field of IVD certification and will also offer comprehensive services in the future.
IVD manufacturers need to navigate their way through a complex landscape of regulatory requirements before selling their products on the international and European markets. They need to make sure their products comply with the respective standards and regulations.
DEKRA is active nearly everywhere in the world and the members of our in-vitro-diagnostic medical devices certification team have extensive expertise in a wide array of in-vitro-diagnostic devices.