On the 16th January, Biomed Alliance published a statement on “Urgent action needed to prevent widespread shortage of diagnostic tests”
For anyone not aware of the current challenges facing the EU (and UK) IVD sector, it is well worth a read. The summary especially provides a really fantastic series of measures which are well worth thinking about.
Their recommendations are: An urgent extension of the transition periods for all IVD classes will provide much-needed breathing room to the sectorEUDAMED must be fully implemented and widely used as soon as possible Special regulatory pathways to facilitate the conformity assessment of rare/niche/orphan IVDs should be created Additional efforts are required to raise awareness, and to provide support and guidance for IVD manufacturers, and particularly SMEs There is a need to simplify the re-certification of legacy devices, that have been successfully on the market without safety issues for a number of years There should be a legislative requirement for manufacturers to report to laboratory professionals and regulators when they intend to take an IVD or medical device off the market at least 6 months prior to withdrawalWhile, In-house IVDs (IH-IVDs) could fill the “CE gap”, Article 5.5, including the requirement of no equivalence to CE-IVDs, discourages their development due to the additional administrative burden and uncertainty of sustainability for IH-IVDs.
From my experience, we need to raise awareness, focusing on, but not limited to SMEs, as they will face the biggest challenge in compliance to the IVDR.
Without making sweeping statements, I feel that it is not a question of SMEs won’t adopt IVDR, it is a case of SME’s don’t have the resources to make that significant jump to compliance.
Given the additional competency, internal mechanisms required for understanding the new requirements, collecting and reviewing clinical evidence and maintaining this, SMEs struggle to gain sufficient investment, or sustain cash flow to support the 3 year + process of IVDR compliance. We have seen that the journey to compliance is possible, including for SME’s. However to do this requires a good understanding of what is required, a focused team and early planning to ensure that the key timelines are met.
We would encourage any IVD manufacturer, SME or not, who is looking to achieve CE marking to make contact with us. The more we are able to inform, encourage and engage with the industry, the more chance the industry has of preventing diagnostic test shortages.