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The In Vitro Diagnostic Regulation - Changes to the IVD regulatory landscape

The IVD industry is about to undergo significant change. Agreement on the final text of the European IVD Regulation has been reached; this legislation will replace the current IVD Directive (98/79/EC), and brings with it an increase not only in the requirements of manufacturers wishing to sell devices in Europe, but also in the number of manufacturers that will be required to do so.

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 As the industry has evolved, the Directive has become outdated.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, 90% of the industry now requires a notified body, drastically increasing the reach of these safety and performance requirements.

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, in particular clinical evidence, and increased control over the wider supply chain.

This webinar discusses the key requirements that IVD manufacturers will need to be aware of, highlighting the areas that are most changed vs. the current IVD Directive. There will be an explanation of the current position and expected timelines, and acknowledgement of the role of the Notified Body, with emphasis on the next steps for manufacturers.


Erica Conway is the Global Head of the IVD Team, with responsibility for aspects of their CE Marking and ISO 13485 activities. Erica manages a global team, with clients of various sizes based around the world.

Before joining BSI, Erica held roles including QA/RA Manager, Regulatory Affairs Consultant and Project Manager within the IVD and pharmaceutical industries. This gave Erica experience in design and development, clinical chemistry, immunology, medicinal product development and companion diagnostics, among other areas. Erica also has expertise in the regulatory requirements of clinical chemistry. Erica is experienced in the implementation and maintenance of ISO 13485.

Erica holds a BSc (Hons) in Physiology from the University of Sheffield, and a PhD in Neurophysiology from the University of Bristol.