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has become outdated.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