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In-vitro-Diagnostic Medical Device Regulation (IVDR)

Achieve IVDR Compliance & Market Access

The In-Vitro Diagnostic Medical Device Regulation (IVDR) (EU 2017/746) sets strict standards for safety, quality, and performance of in-vitro diagnostic (IVD) medical devices in the European market. The growing demand for safer healthcare products led to an update of the European regulations, which resulted in the implementation of the IVDR. Compliance with the IVDR is essential for manufacturers, importers, and distributors to place medical devices on the European market.

What is IVDR (EU) 2017/746?

The IVDR was published on April 5, 2017, and officially enforced on May 26, 2017, replacing the previous IVD Directive (IVDD). A transitional period until May 26, 2022, allowed manufacturers of already approved products to align with the new requirements. The IVDR process introduces:
  • A new classification system for IVDs based on risk levels
  • Enhanced clinical evidence and performance evaluation requirements
  • More stringent requirements for the conduct of clinical trials
  • Stronger post-market surveillance obligations
  • Improved traceability and transparency for patient safety
With the IVDR, access to the European market for IVDs is now subject to stricter regulations, requiring many manufacturers to work with designated Notified Bodies for assessment and approval. The aim of the regulation is to ensure better protection of public health and patient safety.
Why is IVDR Compliance Important?
Manufacturers of in-vitro diagnostic medical devices must comply with IVDR requirements to:
  • Ensure their IVDs meet EU regulatory standards
  • Provide safe and high-performing diagnostic solutions
  • Gain access to the European healthcare market
  • Maintain credibility and consumer trust

CE Marking and Notified Body Engagement for IVD Products

To place an in-vitro diagnostic (IVD) device on the European market, obtaining a CE marking is a regulatory requirement. As a Notified Body, we are designated to conduct conformity assessments under the IVDR, enabling manufacturers to affix the CE marking to their products.
Diagnostic Regulation (IVDR) 2017/746, confirming that the device meets the necessary safety and performance standards.
Under the IVDR, IVD products are classified into risk categories: Class A (non-sterile), Class A (sterile), Class B, Class C, and Class D. Products in Class A (non-sterile) are subject to self-certification, while products in the other classes must undergo assessment by a Notified Body to confirm conformity with the regulation.

Why Choose DEKRA for IVDR Marking?

DEKRA offers reliable conformity assessments for IVDR, verifying compliance with regulatory standards and supporting global market access.
At DEKRA, we offer a unique approach to guide customers through the entire certification journey—from initial onboarding to ongoing surveillance—via a dedicated expert serving as your single point of contact. To further streamline the process, we provide tailored review options such as expedited reviews, modular reviews, and early-stage assessments—designed to support a more predictable and efficient conformity assessment process.​
In addition, we offer specialized approaches tailored to effectively support different types of manufacturers—ranging from start-ups and first-time applicants, to large international organizations, and developers of breakthrough innovations.​
Get in touch with us to explore how we can best support your certification needs.

Declaration of Impartiality

We apply high standards, especially to ourselves
The DEKRA Certification B.V. top management declares the following commitment to impartiality: Our guiding principle is to fulfill and actively live the values which we look for at our customers. Only thus can we perform credibly as a service provider and role model with a customer-oriented approach. The basis for this is provided by our own management system and highest transparency internally and externally.
With the decisions they take in their daily activity, all the employees of DEKRA, including the Management Board, executives and staff, follow the principles of impartiality, objectivity and integrity.
- Bram Holtus, Managing Director
Important documents and more information about DEKRA Certification B​.V​. (Notified Body 0344)