Evolving IVD Regulations in Europe

In Europe, a response was published to public comments on the proposed recast of Directive 98/79/EC. In Australia, the TGA recently published a clarification on application audits for certain IVDs under the restructured system of IVD regulation.

The European Commission has issued a response to public comments on the proposed recast of the IVD Directive, Directive 98/79/EC. Comments were collected between June 2010 and September 15th, 2010.

Feedback was received from a cross-section of stakeholders, including manufacturers, users (healthcare professionals, clinical laboratories), Notified Bodies, and others. In general, the feedback showed strong support for the recast among the stakeholders who responded.

Among the more significant elements of the recast is the proposal to adopt Global Harmonization Task Force (GHTF) recommendations for IVD device risk-based classification. This would mark a significant change from the current system and would likely subject many manufacturers of IVD devices to greater regulatory control. Although the additional regulatory controls would increase costs to manufacturers, it was noted that alignment to GHTF recommendations should also increase the global competitiveness of EU devices. Australia’s TGA has recently overhauled their IVD regulations to align with GHTF recommendations, so this should offer some foresight into the changes to come in Europe. The majority of the respondents indicated that manufacturers of Class B, C, and D IVD medical devices should establish quality management systems that are controlled by a third-party.

Another potentially important change is the proposal to clarify the directive with regard to genetic tests. The current interpretation of the regulations is that only tests with a medical purpose fall under the purview of the directive. Clarifications to this aspect of the directive could broaden its scope and subject more products to regulatory control. In contrast to most other points in the proposal, respondents did not support either of the proposed alternatives put forth.

The general show of support for most of the proposals in the recast is a good indication that the European Commission will likely go forward with the proposed recast.

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