New Device and Diagnostics Legislation Could Shake Up the Drug Industry - Diaceutics

New Device and Diagnostics Legislation Could Shake Up the Drug Industry

September 23rd, 2013

Patrick Considine

Patrick Considine of Diaceutics comments on the 2013 proposals by the European Parliament’s Health Committee to introduce new legislation for devices and in vitro diagnostics. 

This month [September 2013], the European Parliament’s Health Committee will reach its view on the two major proposals launched last year by EU officials — one on devices, and one on in vitro diagnostics. In October, the parliament as a whole is due to agree its definitive opinion on the proposals. And before the end of the year, the governments of the EU’s 28 member states are expected to finalize their position on the proposals, too. So by early 2014, new rules should be signed off that will change the face of EU controls on these products (

If the proposals are passed, a number of changes impacting regulation of IVDs in the EU will be introduced:

  1. The IVD Directive would be replaced by IVD Regulations. EU member states have interpreted and implemented the current directives in different ways, which led to different levels of patient and public health protection in the European Union and created obstacles within the single market. The draft EU Regulations, which are laws unto themselves, do not need to be transposed into law within each member state, as is the case for directives.
  2. The proposed Regulation introduces a new risk-rule classification system based on the Global Harmonization Task Force (GHTF) classification rules which will impact the review requirement for all IVDs. Under the current IVD directive (98/79/EC), approximately 80 per cent of IVD products are grouped in the self-certification class. In the proposed Regulation only 20 per cent of IVD products will remain in the self-certification category, while a form of third-party pre-market intervention will be required for the remaining 80 per cent of products. All ‘human genetic testing’ falls into Class C. This will set a higher bar for device manufacturers than the current self-certification system. Manufacturers of Class C devices will have their quality management systems inspected by national Notified Bodies. This will make approval of IVD products more expensive and slower.
  3. The exemption from the regulations for devices manufactured and used within the same health institution (LDT) is retained, but is now restricted to health institutions compliant with ISO 15189 or other equivalent recognized standard. Labs which are not accredited would only be allowed to use CE-marked tests.


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