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In vitro Diagnostics Directive Regulation (IVDR)
CE Certification under IVDR (EU) 2017/746
Bringing in vitro diagnostic medical devices (IVDs) to the European market calls for a clear and strategic response to the evolving IVDR landscape. With extensive certification experience and deep regulatory expertise, DEKRA supports manufacturers with confidence on their path to successful market access.
A New Regulatory Era for IVDs
The IVDR introduces a significantly more rigorous framework for in vitro diagnostic medical devices. In addition to revised risk classification rules, the regulation places greater emphasis on performance evaluation, post-market surveillance, and traceability. As a result, successful access to the European market depends on early preparation, regulatory precision, and a forward-looking compliance strategy.
Meeting Manufacturer Responsibilities with Confidence
Manufacturers are expected to demonstrate ongoing control over safety, performance, and quality while ensuring full alignment with applicable regulatory requirements. DEKRA helps make complex IVDR expectations more manageable, delivering practical guidance and dependable certification support so that customers can move forward with clarity and assurance.
A Strong Global Certification Network
Within the DEKRA group, two Notified Bodies support conformity assessment under the EU In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746. [DEKRA Certification GmbH]() (NB 0124) was among the first Notified Bodies designated under the regulation in October 2019, and together with [DEKRA Certification B.V.]() (NB 0344), it forms a robust certification framework for manufacturers seeking EU market access. Through this international expert network, DEKRA delivers specialized, reliable support tailored to a wide range of IVD certification needs—helping customers navigate regulatory complexity and build a foundation for long-term success in Europe.