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In-vitro-Diagnostic Medical Device Regulation (IVDR)
Conformity assessment procedure for in vitro diagnostic medical devices
Manufacturers of in-vitro diagnostics bear a strong responsibility for the safety of their medical devices. In order to meet current requirements, Directive 98/79/EC was therefore replaced by the IVDR (EU) 2017/746 Regulation in 2017. As the first Notified Body in Europe, we provide you with comprehensive support for certification in accordance with the new regulation. Rely on our expertise in the field of in-vitro diagnostics
Given the extensive requirements for Notified Bodies under the IVDR and the extended transition periods, DEKRA has made the strategic decision to consolidate all DEKRA IVDR (EU 2017/746) activities under a single IVDR Notified Body, DEKRA Certification B.V. 0344. As a result, DEKRA Certification GmbH CE0124 will relinquish its IVDR designation effective April 1, 2025, and subsequently continue its IVDR activities under DEKRA Certification B.V. 0344. This decision has no impact on the DEKRA MDR Notified Bodies, which will retain their respective designations. This step will enable DEKRA to streamline operations, strengthen global IVDR expertise, and enhance its ability to serve a diverse customer base. By combining the IVDR activities of the two notified bodies, DEKRA is well positioned to manage the complexity of the evolving regulatory landscape while maintaining its commitment to high-quality service and expertise.
Advantages of IVDR (EU) 2017/746 certification
- Increased liability and legal certainty
- Product-specific regulations through a risk-based classification system
- Increased transparency thanks to the European database (EUDAMED)
- Improved opportunities for successful EU market entry with the CE mark
IVDR (EU) 2017/746 certification at a glance
With the adoption of the IVDR (EU) 2017/746 in the European Parliament, manufacturers of in-vitro diagnostics had to prepare for a variety of changes to the certification of their products. The new regulation has been in force since May 2017; different transition periods apply for the application of the regulation until 2027 at the latest, depending on the risk classification.
The new regulation explicitly involves notified bodies more closely in the certification process. We can draw on the many years of experience of our experts in the medical device industry and assist in your conformity assessment procedure for IVDs. As an accredited certification body, we also certify quality management systems in accordance with EN ISO 13485 in companies that manufacture or distribute IVDs and medical devices or are part of the supply chain.
The IVDR (EU) 2017/746 is the new regulatory basis for the placing on the market, making available and putting into service of IVDs. The regulation applies throughout the EU and replaces the former Directive 98/79/EC.
The regulation requires the involvement of a notified body for significantly more in-vitro diagnostics and provides a new classification system. In addition, the requirements for the vigilance system and post-market surveillance have been significantly tightened. The holistic approach of the regulation, which applies to IVDs that are only used in medical facilities as well as regulations for modern, digital products (e.g. apps), is particularly important here. At the same time, in addition to increased personnel responsibility in companies, notified bodies will also be more integrated into the conformity assessment process. This is intended to ensure the transparency and neutrality of the assessment, while the introduction of the UDI (Unique Device Identifier) will simplify the traceability of products. The European database (EUDAMED) also plays a major role here, ensuring better distribution of information throughout Europe.
The main innovations under the IVDR (EU) 2017/746 include
- A new classification system: the previous list-based system will be replaced by a risk-based classification system. This comprises risk classes A to D. Class A products have the lowest risk and class D products the highest risk for individual patients and the public.
- Extended requirements for near-patient tests, products for self-testing and companion diagnostics.
- Clarification of the requirements for the preparation and maintenance of technical documentation for medical devices, in particular for the performance evaluation of in vitro diagnostic medical devices.
- Extension of the requirements for clinical evaluation: proof of clinical studies to evaluate the performance of the IVD and the collection of clinical data after the product has been placed on the market.
- Introduction of an additional control procedure for high-risk medical devices by a panel of experts (scrutiny procedure).
- Extension of the provisions on post-market surveillance of the in vitro diagnostic medical device and the vigilance system.
- Improving the identification and traceability of products by introducing a unique device identification number (UDI).
- Enhanced transparency through the European database (EUDAMED): This stores the contact details of the manufacturer or authorized representative for the IVD on the market. It also contains information on the product, the certificate, incidents and clinical trials.
- New regulations on the use of software as a medical device
Your partner for the certification of your in-vitro diagnostics
- Benefit from our many years of expertise in the certification of medical devices.
- Enter international markets with our range of transnational standards for medical devices, for example for the USA, Canada, Japan, Brazil, Taiwan and the UK.
- Save time and resources with our effective, proven processes for rapid certification.
