Divyaa Ravishankar's Blog

Formal Adoption of Changes to European Regulation of In Vitro Diagnostics Begins in 2014

17 Jan 2014 | by Divyaa Ravishankar
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The current regulatory framework for in vitro diagnostics (IVD) is provided by the Directive 98/79/EC of the European Parliament. The new and stricter regulation framework is expected to start in 2014 and is in accordance with the Global Harmonization Task Force on Medical Devices (now operating as the International Medical Device Regulators Forum) guidelines. Examples of major changes include the risk classification system with special requirements for companion diagnostics. According to the current EU IVD directive, companion diagnostics are classified as low risk, so most manufacturers tend to self-assess and self-certify companion diagnostic products to obtain a CE mark for the European market. The new IVD regulation is specifically targeted toward tests such as genetic tests and companion diagnostics that have a key role in providing information to product treatment response or reactions. As per the new classification, all of these tests will be required to have proper authorization, pre-market clinical evaluation, post-market clinical follow-up, and surveillance.

It is expected that the new European Union (EU) regulatory framework for in vitro diagnostics (IVD) will introduce significant changes to the previous regulatory framework, which could affect costs associated with new product launches and thus the product development pipelines of major IVD companies. Compared to the
FDA regulations for IVD, the EU IVD regulations have been less stringent and, consequently, IVD companies often launch products in Europe before the United States. While a framework for co-development of targeted therapies and associated companion diagnostics has been established by the FDA to guide the commercialization of these
drug-companion diagnostic pairs, the lack of framework in Europe for this relatively new industry has been a challenge for companion diagnostic companies that plan to market a targeted drug or companion diagnostics in Europe. Nearly all diagnostic tests in Europe are classified as low risk and are exempt from pre-market evaluation.
This is an incentive for companies to launch products in Europe as there is a higher rate of approval for new tests and products compared to the US, for instance. The new IVD directive will position companion diagnostic tests in the high-risk category with additional regulatory hurdles that would increase costs and timelines in co-development, requiring IVD companies to update their regulatory strategies for Europe.


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