The European Commission has revealed minimal progress in the pipeline of notified bodies seeking designation against the incoming In Vitro Diagnostic Regulation.
As of Oct. 21, six notified bodies had reached the corrective and preventive action (CAPA) stage of the designation process, up from five when the Commission shared an update in March.
The pipeline suggests only a few notified bodies are likely to join the four already designated over the coming months, leaving a small pool of organizations responsible for the work that needs to be completed by May 2022.
The IVDR is set to go into effect May 26, 2022. With the Medical Device Regulation originally due to take effect in May 2020, the state of preparations for MDR has had a higher profile than readiness for IVDR. Yet, the changes needed to implement IVDR are at least as significant as those for MDR.
As the IVDR deadline has drawn closer, and COVID-19 and the one-year MDR delay have applied further pressures, the diagnostics industry has escalated its warnings about readiness. In July, MedTech Europe said "timely implementation" of IVDR is "highly doubtful," pointing to the lack of notified bodies to make its case. The trade group said manufacturers will need to seek certification of most IVDs by early 2021 to be ready by the date of application and avoid "catastrophic disruption."
The update from the Commission sheds light on the number of notified bodies that are likely to be in a position to receive submissions to certify products under IVDR by early next year. As of Oct. 21, the Commission had added four notified bodies to its NANDO database. A fifth notified body has received the recommendation of the Medical Device Coordination Group (MDCG) but is yet to be designated.
One other notified body is at the CAPA review stage, putting it several steps, and based on the progress of its peers at least several months, from being designated. If that notified body gets to the designation stage by early next year, there could be six notified bodies ready to receive applications by the time MedTech Europe says they will need to be filed.
Other notified bodies have begun the designation process but, unless work accelerates significantly, most of them are unlikely to be in a position to receive certification filings more than 12 months before IVDR implementation. Two notified bodies have undergone on-site assessments but are yet to submit CAPA plans. Another four have received preliminary assessment reports but are still waiting for on-site assessment.
The composition of the pipeline suggests that at some point the shortfall of notified bodies will abate. More than two-thirds of notified bodies designated under the outgoing IVD directive have applied to be designated under IVDR. The problem is around half of the applicants are yet to advance beyond the first few steps in the designation process.
The Commission shared the update on IVDR alongside an overview of the pipeline of MDR notified bodies. The number of notified bodies in NANDO now stands at 17. One other notified body has received MDCG recommendation and is awaiting designation. A further 10 notified bodies are at the CAPA review stage, suggesting the number of designated companies could rise quickly.