The new classification scheme resulting from the IVDR will have a huge impact on both manufacturers and Notified Bodies (NBs). This article explores the reasons why.
Below, we’ve highlighted some of the changes for NBs and manufacturers, respectively. First let’s review something that impacts both – classification. Previously, under the IVDD, if an IVD device did not fit into any of the other classes, it would be self-declared. Now, under the IVDR, the IVD devices will be classified as Class B, and thereby fall under Notified Body (NB) supervision. This has a huge impact on especially self-declared IVD devices as most of them must now be certified by a NB under the IVDR. In fact, it is estimated that while previously only 20% had to be certified by a NB, the number will now be 80%. Of course, this number can be higher or lower depending on the portfolio of the company.
Impact on NBs
In addition, the IVDR requires re-designation of all NBs. This is expected to reduce the overall number of NBs, adding to the (already increased) workload of those that remain. Annex VII of the IVDR describes the requirements for obtaining the NB role. Under the IVDR, NBs must be re-assessed within three years, and again every fourth year thereafter, to determine whether they still satisfy requirements.
NBs must have sufficient resources, with relevant experience and the right skill set, to carry out their obligations as described in the IVDR. This is more challenging than one might think, since the number of professionals with IVD-experience is already limited. Now, NBs, manufacturers and others will be competing over the same limited number of experts. This resource limitation, combined with the fact that the designation procedure hasn’t yet started, may certainly cause delays for many manufacturers.
Like manufacturers, NBs must operate a comprehensive Quality Management System (QMS) to demonstrate consistent fulfilment of requirements. This includes documented processes and sufficiently detailed procedures for the conduct of each conformity assessment activity. One of these activities is unannounced on-site audits of manufacturers and when applicable, of subcontractors and suppliers.
Annex VII instructs NBs to examine the procedures as well as the techniques manufacturers use to address issues such as the identification of legal requirements and classification, and the choice of conformity assessment procedures used. They must also pay attention to how the manufacturer addresses general safety and performance requirements, as well as the risk management system.
The IVDR also introduces a mechanism for scrutiny of the NB’s conformity assessment, as the NB will notify Competent Authorities of certificates granted for high-risk devices. The Competent Authority may, based on reasonable concerns, apply further procedures or request scientific advice from expert panels in relation to the safety and performance of any device.
Impact on Manufacturers
For the IVD manufacturers, there is another requirement that they must take extremely seriously. The IVDR requires manufacturers to employ at least one person responsible for regulatory compliance to handle things like technical documentation, post-market surveillance and vigilance efforts, etc. This person must demonstrate his/her qualification in one of the following ways:
The manufacturer must ensure that the requirement for one or more persons responsible for regulatory compliance can be met by the end of the transition period, as well as afterwards.
The IVDR ensures liability throughout the distribution chain by applying legal and regulatory responsibilities to all participants in the distribution chain, depending on circumstances under which the IVD device is put on the market. For example, a non-EU manufacturer is required to appoint a European Authorized Representative in the EU before putting an IVD device on the market in EU. In this case, the Authorized Representative is not only responsible for verifying compliance with the IVDR, but will also be legally liable, along with the manufacturer, for any defective devices placed on the market that fail to comply with the IVDR. Therefore, the Authorized Representatives must also have at their disposal at least one person responsible for regulatory compliance under the same terms as the manufacturer. For more information about the legal responsibilities in the distribution chain, please refer to the IVDR.
As mentioned in the first article, the QMS must include a post-market surveillance system to address general safety and risk management. This system is necessary to be able to gather data in a structured manner. This data is used to:
To demonstrate how this is addressed it is important that the QMS reflects that a strong post-market surveillance system is in place. This will also ensure continuous improvement of the IVD devices.
If a company fails to comply with the IVDR after the transition period and the certificates issued per the IVDD are about to expire, it will be highly unlikely that the company will be able to distribute products in the EU market. More information can be found in the IVDR itself. 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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