One year IVDR – certification stress and why you need to act now

On June 30th, the Dutch RAPS chapter organized a meeting focused on the IVDR and the bottlenecks caused by about 10,000 IVD devices that still need to obtain IVDR certification.

During the meeting, the bottlenecks related to the IVDR transition and certification were discussed from different perspectives: The Dutch Inspectorate presented the results of a recent survey among IVD manufacturers. Notified Bodies are facing a decrease in applications now but expect a peak in applications towards the end of the transition periods for class D (26-May-2025) and class C IVD devices (26-May-2026). For large and small manufacturers, generating IVDR-compliant performance data and technical files for timely transition is challenging and requires considerable resources. Clinical labs struggle with uncertainty about patient tests that the manufacturer may discontinue, while at the same time, the requirements for the use of in-house tests have also increased.

Sincere efforts are needed from all involved stakeholders to prevent shortages in IVD devices and ensure continued patient access to diagnostic testing. 

What do I need to do as a manufacturer?

• Make sure to prepare everything for a smooth transition of your IVDD legacy devices. Notified Bodies indicate that the technical file review should be started before the end of 2023 for all class D devices and before the end of 2024 for all class C devices. 
• If you have already prepared IVDR-compliant technical documentation, don’t postpone your application with a Notified Body. Notified Bodies indicate that they currently have availability within a reasonable time frame but expect a peak just before the dates given above. Remember that the Notified Body review may take 18-24 months, including multiple rounds of questions.
• If you are still working on your technical file or generating (clinical) performance data, you must prioritize these activities to ensure that your application will be well ahead of the abovementioned timelines. Don’t wait for guidance documents, and if your Notified Body has not been designated yet under the IVDR, you may want to consider transferring to an IVDR-designated Notified Body.
• To ensure your Technical File is complete and complies with IVDR, address all applicable IVDR Annexes I – III requirements. Use the Best Practice Guidance published by Team-NB (the Notified Body Association) and make sure to follow the specific guidance of your Notified Body, including numbering and structure of the documentation (e.g., BSI’s IVDR Documentation Submissions Best Practice Guidelines.

More knowledge about EU-IVDR one year on?
Watch our On-Demand Free Webinar EU-IVDR one year on, hosted by Sue Spencer on the 25^th of May 2022. The webinar discussed the current state of play, including transitional arrangements, successful strategies, common pitfalls, and the most common issues giving rise to Notified Body questions.