IVDR: a small update of IVD regulations

Table 1: Timeline for IVD registration under the IVDR

IVDD vs IVDR: differences and challenges

Implementing the IVDR will introduce a range of new challenges to IVD businesses. One of the most significant of these is the transition to a rule-based regulatory classification process.

Under the IVDD, classification was defined through the application of Annexes II and III. In comparison, under the IVDR, use-based rules are applied to derive the risk posed by a device. This is aligned with the approach taken for medical devices.

The IVDR classification system has four classes, i.e. A to D, D has been defined as carrying the most risk, down to A with the least risk. Table 2 outlines the different classes and examples of devices that sit within each class.

Table 2: Risk-based classification of IVDs

Useful reference: MDCG2020 – 16 Rev 1 Guidance on Classification Rules for in vitro DiagnosticMedical Devices under Regulation (EU) 2017/746

There is a provision within the IVDR to allow legacy devices (those placed on the market under the IVDD) to remain on the market during the transition window defined in Table 1. There are, however, significant restrictions imposed on any changes to the device in order to continue marketing during the transition, and any of the following key device changes would drive transition to the IVDR:

• Any change in the intended purpose
• Any significant change in the product, including:
  o Changes to product design
  o Changes to software
  o Changes to ingredients or materials
  o Changes to sterilisation, or changes to packaging that could impact sterilisation.

There is a Medical Device Coordination Group (MDCG) document (MDCG 2022-6) that provides guidance to indicate the types of change that would be considered significant. While this is a guidance document only, many NBs follow these and expect manufacturers to as well.

The rollout of the new IVDR

The actual transition process itself will require the involvement of a Notified Body for all but Class A non-sterile devices, which will remain as self-certified by the legal manufacturer. In a vast number of cases, legal manufacturers are submitting to an NB for the first time against the new requirements of the IVDR. The manufacturer will be required to undergo a QMS audit and submit a full technical documentation, including clinical evidence (scientific validity, analytical and clinical performance data) to support the intended use and clinical benefit of the products. As a result, manufacturers can expect much higher costs and increased time to get their product to market, or indeed removal of products from market if they fail to meet IVDR requirements.

In addition, one of the perhaps unforeseen issues with the IVDR rollout is the relatively low number of NBs that are approved to review products against the IVDR (only 6 as of January 2023). There is therefore a significant risk of a bottleneck developing for IVDs waiting to get to market and there is potential for a significant number of IVDs not gaining registration under the IVDR before the deadline for conformity.

To counter this, the European Commission generated a proposed amendment seeking to delete the ‘sell off’ clause contained within the IVDR, thereby allowing devices legally placed on the market after the end of the transition period under the IVDD to continue being sold until their actual expiration date. This proposed amendment passed successfully through the European parliament in February and was approved unanimously on the 7th of March 2023 by the European Council.

This will ensure that safe and effective IVDs that would have otherwise been removed from the market can continue to be made available until their actual expiry date.

The table below shows a summary of key new IVDR requirements as well as some of the potential challenges facing the manufacturers.