IVDD transition to EU IVDR
The transition time for In vitro diagnostic medical devices (IVDs) to comply with the EU IVD Regulation 2016/746 (IVDR) is arriving at its end: IVDR will be fully implemented from 26 May 2022. New IVDs will be obliged to comply with the IVDR, whereas IVDs certificates under the IVD Directive 98/79/EC (IVDD) will not last longer than 27 May 2024. The clock is ticking, and be aware, IVDR compliance requires far more work than IVDD. With this in mind, here in this article, we aim to summarize the main changes between IVDD and IVDR, including some guidance for manufacturers to adapt their documentation for IVDR compliance.
What is new in the IVDR?
The IVDR evolved from the IVDD to establish a more “robust, transparent, predictable and sustainable framework for IVDs”. With this premise, the IVDR incorporated the same basic regulatory processes from the IVDD and added new requirements. Some of the new requirements include:
- Broadened and clarified definitions for IVDs.
- Novel risk classification: from class A (lowest risk) to class D (higher risk).
- Increased responsibility for Notified Bodies (NB) to assess whether a product meets required criteria.
- Higher standards of quality and safety for IVDs.
- Improved oversight and traceability throughout the supply chain and lifecycle of the IVD: application of unique device identifiers (UDI) and the requirement of uploading manufacture data to the public European Database for Medical Devices (EUDAMED).
Consider visiting the following link to get more information about the IVDR.
1. IVDR definitions and scope
The definition of IVD is broadened and clarified under the IVDR to include more types of devices, such as diagnostic services, genetic testing, companion diagnostics, and software. Some new definitions are also introduced in the IVDR, such as “near-patient” testing and “companion diagnostics”. Note that testing services offered over the internet are also under the IVDR scope when commercialized in the EU.
2. Novel risk-based IVD classification
One of the most significant changes introduced by the IVDR is the novel classification for IVDs. The IVDR specifies a clear set of rules for classifying IVDs into four risk categories, ranging from class A (lowest risk) to class D (highest risk). Notably, manufacturers must determine the class of the IVD independently of how it was classified under the IVDD. Annex VIII of the IVDR provides the list of rules required for IVD classification.
Manufacturers should note that under the IVDD, most of IVDs did not require NB oversight and could be self-certified (~80%). In contrast, the IVDR turns this ratio on its head, and around 85% of devices now fall into risk classes that require NBs oversight.
IVD classification under the IVDR is further explained in the following article: https://akrnconsulting.com/classification-ivd-under-ivdr/
3. Increased responsibility for NBs
Under the IVDR, NBs have adopted higher competencies for scientific and technical evaluations. Consequently, becoming an NB requires tighter criteria and more extended evaluation periods (up to 12 months). As a result, only 5 NB are available in the EU for the increasing number of IVDs that require NBs oversight: i.e., NBs are bottlenecks. Manufacturers may consider this fact when planning the timelines to place an IVD in the EU market.
4. Higher standards of quality and safety
The IVDR gives more focus on the management of the entire lifecycle of IVDs, including a continuous evaluation of post-market phases of the product:
- Requirements for manufacturers to demonstrate effective quality management systems (QMS)
- Requirements for demonstrating clinical evidence (referred to as “performance evidence” in the IVDR) are more stringent and become progressively tighter as the risk class increases. Additionally, performance evaluation is based on:
- Scientific validity
- Analytical performance
- Clinical Performance
Consider reading the following article for more information regarding IVD Clinical Performance Studies (https://akrnconsulting.com/ivd-clinical-performance-studies/).
- Novel and higher requirements for post-market performance follow-up to continuously evaluate the IVD throughout the device’s entire lifecycle.
5. UDI and EUDAMED: increased transparency and traceability
One of the main reasons for developing the IVDR was to increment the transparency and traceability of products placed in the EU market. For this purpose, the IVDR introduces the unique device identifiers (UDIs), codes placed on the IVDs for helping in their identification and traceability. The assignation of UDIs is performed by some issue entities and must be renewed every five years. To facilitate such traceability, manufacturers are responsible for entering UDIs and other relevant data into the European public database (EUDAMED). Consequently, EUDAMED helps improve transparency by functioning as a system for registration, notification, and dissemination of information for IVDs products placed in the EU market.
Do you feel ready? AKRN will assist you
The IVDR provides a new regulatory framework for placing IVDs in the EU market. The extended scope of regulatory oversight has caught some manufacturers unawares, and those who have postponed the transitioning to the IVDR may feel the pressure to adapt soon. AKRN specializes in IVDD to IVDR transitioning. As part of our regulatory services, AKRN can assist IVD manufacturers in fulfilling the requirements needed to place IVDs in the EU market. Such services, including technical documentation preparation and performance evaluation assessments, will help manufacturers for smooth transitions and compliance with the EU regulation.