Connect the IVDR puzzle pieces with confidence

Understand the latest IVDR changes and the impact for IVD manufacturers

By IQVIA MedTech

About 70 percent Because today’s medical decisions depend on the results of laboratory diagnostic tests and the associated devices used, regulatory authorities aim to further strengthen critical oversight of devices in development and use. In May 2017, the European Commission announced the new In vitro Medical Diagnostic Devices Regulation (IVDR) 2017/746 to improve the quality, safety and reliability of IVDs.

Replacement In vitro Diagnostics Directive (IVDD) 98/79/EC which have been in place for over 20 years, the updated regulations have given IVD manufacturers a five-year transition period to ensure compliance whether for an IVDD currently available or for those in development. The changes and updates were to be fully applicable on May 26, 2022 in the European Union. However, in October 2021, the European Commission proposed a phased rollout of IVDR, given the evident delays faced by the COVID-19 pandemic and other overriding challenges for IVD manufacturers to make the necessary updates. . And the fact that all the necessary pieces of the IVDR puzzle are not yet in place was also a factor for the schedule update. The Regulation of the European Parliament of the Council amending Regulation (EU) 2017/746 as regards transitional provisions applicable to certain in vitro diagnostic medical devices and deferred applications of conditions for internal devices has been published in the Official Journal (OJ ) of the European Union on January 25, 2022.

As it stands, the IVDR will be fully applicable on May 26, 2022, as previously stated when announcing the new IVDR regulations. However, many products will now have a grace period to comply with the regulations. Extended dates depend on the hazard classification of the product.

As many manufacturers have more time, understanding the need to better address patient safety issues for IVDs and the challenges of meeting compliance even with expansion, this is a critical time for the industry. Staying equipped with the latest in the IVD regulatory landscape and knowing how to successfully navigate the changes in time for respective product deadlines is essential for manufacturers in the space.

IVDR: notable changes

By raising standards and increasing regulatory oversight of IVDs, what an IVD is and how it is classified is being newly defined. Although the spectrum of IVD products (e.g., rapid diagnostic tests, blood glucose tests, genetic health risk tests, home use tests, etc.) under regulatory oversight remains consistent from IVDD to IVDR, the degree of documentation and review of IVDs will increase significantly.

Overall, the components of IVDR that will impact IVD development and commercialization are quite extensive and game-changing for manufacturers:

  • To regulate the medical device market, it is necessary to classify IVD medical devices according to the potential risk they pose to patients and users. A new risk classification system will designate products into four classes, namely Class A, B, C and D. Regulatory controls are commensurate with the level of risk associated with the class of IVD medical devices:
    • Class D (highest risk): covers life-threatening conditions and transmissible blood agents that pose a high risk to the general population and biological materials used in transplants
    • Class C (moderate to severe risk): covers high-risk IVDs that pose less risk to a wider population but can be life-threatening
    • Class B (moderate risk): covers all IVDs that do not fit into other classifications and poses a lower risk to the patient and wider population than classes D and C
    • Class A (low risk): covers laboratory apparatus, instruments and sample containers
  • Requirement for Notified Body (NB) certification for conformity assessment procedures for all IVDs except those classified as Class A products
  • Revised and strengthened clinical evidence, including scientific validity, analytical performance and clinical performance
  • New General Safety and Performance Requirements (GSPR) instead of Essential Requirements Checklist (ERC)
  • In vitro diagnostic medical device software, the product must meet the definition of an in vitro diagnostic medical device in accordance with Article 2(2) of Regulation 2017/746
  • Traceability via UDI and more transparency via the EUDAMED database
  • A new definition of Companion Diagnostics (CDx) and the specific conformity assessment pathways for these IVD products
  • Compared to the IVDD, the IVDR places more emphasis on life cycle management and continuous product evaluation. The IVDR requires manufacturers to demonstrate that they have an effective quality management system (QMS) in place resulting in documentation changes for all products
  • Implementation of thorough and proactive post-market surveillance (PMS) systems

Additionally, under the IVDR, there will be pressure to increase transparency in development and commercialization for IVD manufacturers, who will soon have to disclose efforts to reduce the risks of IVDs to patients and work to develop, implement and maintain a risk management system.

Going beyond enhanced oversight through approval for use, the updated regulations will impact post-market evaluations and related compliance assessments. And, with time running out, manufacturers will need to focus more (and quickly) on planning efficient and effective regulatory and marketing strategies to meet IVDR requirements.

Interested in learning more about the impact of the IVDR on your regulatory, quality and risk management systems? Let IQVIA MedTech experts collaborate with your team and demonstrate effective strategies to prepare your products for IVDR. Learn more about

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