Feb 25, 2011

Comments following European Union regulators’ public consultation on proposed revision to Directive 98/79/EC indicate strong support for adopting a risk-based classification for in vitro diagnostic devices (IVDs).

Among 116 manufacturers, notified bodies and other medical device industry stakeholders that provided comment, 93% of respondents saw the adoption of risk-based IVD classification based on the Global Harmonization Task Force (GHTF) model as a positive development, allowing for greater flexibility, stronger public health protections and timely market access for new products.

The cost of such a reclassification, however, was also highlighted by some respondents. Specifically, classification according to GHTF standards would necessitate greater regulatory involvement to handle conformity assessment procedures. In turn, manufacturing costs would increase, ultimately driving up prices for end users as well.

Nonetheless, respondents noted that additional costs would likely be offset by improved public health protections, and suggested a five-year transitional period for manufacturers to adjust to the new risk-based classification and its ensuing requirements. In addition, a risk-based IVD classification incorporating the GHTF model would boost European exports, some participants stated, but only if such classification were based on that model—otherwise, additional regulatory costs would not be offset by any financial benefits.

At this point, the EU Commission may discuss and consider these comments and then provide a draft which will likely include GHTF classification rules.

If EU regulators end up adopting these classification rules, Europe will become the second major market after Australia to implement GTHF risk-based classification rules for IVDs.


  • Stewart Eisenhart