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Why is this change so significant for IVD manufacturers?
The current legislation, in the form of the IVD Directive, was written for a young industry, without broad scope or scalability. As the industry has evolved, the Directive has become outdated. The new Regulation addresses some of the challenges posed by the Directive, including a new rule-based classification system for products, superseding the current list-based approach. This in itself makes the Regulation more practical, by allowing it to remain relevant to an innovative and growing industry. It also means that a far larger number of IVD manufacturers require a notified body to certify their products, as classification rules are applied to all IVDs, rather than using an exclusive list of specific products to determine which require a notified body. Under the IVD Directive, 90% of the industry could self-certify, but with the Regulation, up to 90% of the industry now requires a notified body.
In addition to the change in classification rules, we also see increased harmony between the IVD Regulation and the equivalent Medical Device Regulation, including a focus on clinical evaluation, and increased control over the wider supply chain.
This white paper from BSI guides you through the IVDR legislative changes. This useful paper provides a checklist, allowing you to see how the Regulation will impact on current manufacturer operations and what you need to consider before the Regulation comes into force, both during the transition period and after it is implemented. Co-Authored by Dr Gert Bos, former Head of Regulatory Affairs at BSI, and Erik Vollebregt, Partner at Axon Lawyers, the white paper is the most recent in a series from BSI to support you through the transition from the IVD Directive to the IVD Regulation.
