October, 2017: The new In Vitro Diagnostic Regulation (IVDR) aims to provide a transparent and sustainable regulatory framework. One of the fundamental changes compared to the former In Vitro Diagnostic Directive (IVDD) is the new classification structure. Previously, under the IVDD, the classification was dictated by a simple and rigid list-based system that allowed for different decisions by different EU Member States (MS). To reduce this risk, the IVDR introduces a new, risk-based and flexible classification system, better suited to accommodate changes.
The IVDR specifies four risk-based classes (A-D) for In-Vitro Diagnostics (IVD) devices. Class A includes IVD devices with lowest risk and is the only class that does not fall under Notified Body (NB) supervision. Class D is the highest risk category.
The classes are based on the Global Harmonization Task Force classification scheme and are determined using seven rules, which are explained in more detail in Annex VIII of the IVDR. We must highlight here that the new classification will not just apply to all new IVD devices going forward. It will also apply to all existing IVD devices. This means that all existing IVD devices on the market must be re-classified in the new system.
The new classification scheme means that IVD devices not fitting into any of the classes will be considered Class B, falling under NB supervision. This is an important distinction, because they would have been self-declared previously, under the IVDD. While 20% of IVD devices were self-declared under the IVDD, the number is expected to jump to 80% under the IVDR. It can be higher or lower depending on the portfolio of the company, but is expected to have a huge impact, regardless. The impact will hit especially hard on self-declared IVD manufacturers, who must now be certified by a NB. This issue will be examined further in Part 3 of this 5-part series.
As illustrated above, it is important to correctly determine the class because this will dictate whether NB certification is needed. In addition, the class also determines the level of documentation required. For example, conformity assessment procedures are dependent on the classification of the IVD devices.
The level of assessment depends on the classification and includes a review of the Quality Management System (QMS) and the technical documentation. High risk IVD devices receive more scrutiny than lower risk IVD devices. Details about the conformity assessment procedures can be found in Annexes IX-XI in the IVDR. To successfully comply with a conformity assessment, the IVD device documentation must:
Class D IVD devices, with “high individual risk and high risk for public health”, must meet the highest level of conformity. EU Reference Laboratories verify performance claims and do other testing on Class D IVD devices, and thus play a large role in conformity assessments.
It is impossible to ignore the IVDR’s huge impact on all parties involved in the certification of Class B, C and D IVD devices. For example, NBs will experience significantly increased workload due to the new classification scheme. Please stay tuned for Part 3 of this series, which will address the impact on NBs and more details about the QMS requirements for IVD manufacturers.
More information can be found in the IVDR and its Annexes. Notified bodies also have online publications on their websites:
About this Expert Article Series
Stay tuned for more detail as we dig deeper into some of the key implications of the IVDR in the rest of this 5-part series. Specifically, this series includes:
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