Overview of Main Changes Brought About by the IVDR
The IVDR shares many of its new features with the MDR (EU regulation 2017/745). Apart from the new elements shared with the MDR and the consequences for the market entry and surveillance (like the new supply chain regime, use of unique device identifiers (UDI) and a central database that is the European database on medical devices (EUDAMED)), there are three major reforms in the IVD field:
IVDs will no longer be subject to the list-based system currently in the IVD Directive, but to a new system based on the risk classes developed by the Global Harmonization Task Force, dividing the landscape of IVDs into risk classes A (low-risk) to D (high risk) with seven classification rules (see Figure 1) based on the intended purpose of the IVD. With notified bodies having to perform conformity assessment on all but class A (nonsterile) devices, the landscape is dramatically changing in terms of files to be reviewed and audits to be performed pre- and post-market.
The conformity assessment routes for IVDs are amended to fit the new classification logic. IVDs that do not fit any of the other classification rules fall into class B and have to be certified by a notified body. This is a major change compared to the IVD Directive, which allows such IVDs to be self-certified. As a consequence, approximately 90 per cent of all IVDs will need to be certified by a notified body under the IVDR, as compared to less than 20 per cent currently under the IVD Directive.
Performance evaluation will be required to support the CE mark under the IVDR. As a consequence, IVD manufacturers will need to produce significantly more clinical evidence. The IVD Regulation contains rules for performance studies. It is crucial for manufacturers of IVDs to plan the generation of additional clinical evidence well, and to assess what clinical evidence will be required, how long it will take to generate this and to plan for notified body review timing for conformity assessment. The performance evaluation will include a qualified assessment of the clinical evidence for the device including the benefit/risk and the clinical and analytical performance and scientific validity of the IVD.
Steve Lee, Director, Diagnostics Regulation, ABHI
Note: this article was originally written for BSI's Compliance Navigator for Medical Devices platform.