CONGRESS 2023 - In-house tests to CE marked - Impact on the laboratory (Debate – impact on laboratory vs commercial company)

The IVDR is the new regulatory instrument for placing IVDs on the European market. The aims of the IVDR are to provide a robust, transparent and sustainable IVD framework, harmonize divergence in implementation (as experienced with the IVDD) and most importantly to increase patient safety. The document runs to 156 pages (compared to 43 for the IVDD, containing 114 articles and 15 annexes. The IVDR places more emphasis on the economic operators (actors) involved in the IVD supply chain, from the manufacturer to the customer. Manufacturers have the obligations to design and manufacture products in compliance with the IVDR; evaluate product performance and manage risk, have a Quality Management System, create and maintain product technical documentation, conduct post market surveillance, and implement field safety corrective actions. One of the biggest changes with IVDR is the introduction of a new rules-based approach for product classification. Under IVDR, Notified Bodies perform conformity assessment on 80% of IVDs (compared to 20% under the IVDD, which becomes stricter as the risk class increases. There are also enhanced concepts for performance evaluation and clinical evidence. Under the IVDR there is a requirement to state the clinical purpose in the intended use. Thus, in order to comply with the new regulation, manufacturers must revise all intended purpose statements in product labelling. Further, there is the obligation to gather a large amount of data to evaluate both analytical and clinical performance. Manufacturers are required to continually evaluate performance across the whole product lifecycle through post market surveillance and vigilance, with reports for the highest-risk devices uploaded to the new EUDAMED database on an annual basis.

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