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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.
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.
- Notified Body Expertise – A team of qualified auditors and product reviewers conducts conformity assessments in accordance with IVDR requirements and is readily available to take on your project.
- Expert capacity – DEKRA has the resources and expertise to support conformity assessment procedures under the EU IVDR for projects of any scale or complexity and with competitive timelines. Keeping customers informed and up to date throughout the process.
- Proven Track Record – DEKRA specializes in certifying high-risk and innovative medical devices, verifying compliance with complex regulations and evolving industry demands.
- Onboarding Package – How we are supporting IVDR newcomers in working under the new regulations and with a Notified Body for the first time to make the journey a success – before, during and after. (resp. training, guidance documents, and clarification meetings (structured dialogue).
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.
Get IVDR Certified With DEKRA
Reach out to DEKRA today and take the first step towards IVDR marking for your IVD products.
DEKRA is designated for the majority of codes, including activities under Article 16 of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR).
Our scope of designation, can be verified on the NANDO website:
ISO 13485 certification is not mandatory for medical device manufacturers, but it is highly recommended to combine it with your CE IVDR conformity assessment. ISO 13485 outlines the requirements for a quality management system (QMS) tailored to medical device manufacturers and is recognized as a harmonized standard under the IVDR framework. This means compliance with ISO 13485 can support regulatory conformity and streamline the CE IVDR marking process.
Obtaining ISO 13485 certification is often a beneficial first step, as it establishes a quality management system aligned with the requirements of the EU In Vitro Diagnostic Medical Devices Regulation (IVDR) and facilitates preparedness for conformity assessment by a Notified Body. This approach helps organizations understand the regulatory expectations and streamlines the process.
