Evolving IVD Regulations

(Published February 2011)

We are writing you with two updates in the IVD regulatory world. 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.

Response to Public Comments on EU Recast of Directive 98/79/EC

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 15^th, 2010.[1]

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.  

TGA Clarification on IVD Audits

As previously reported,[2] the TGA reformed IVD regulations in 2010 to align with GHTF recommendations, adopting a risk-based classification system. Under the new system, many IVDs will be subject to more rigorous controls, including random and mandatory audits. TGA has now published multiple IVD guidance documents.[3]

The TGA has most recently issued guidance outlining several key points regarding IVD application audits (Technical File Review), including:

• general purpose of an audit
• application audit process 
• expectations for a Technical File
• criteria for mandatory audit
• audit fees
• documents requested in an audit

This document should be of value to manufacturers and regulatory professionals, both as a means to comply with TGA expectations, and to prepare for and manage a TGA audit. The full text can be found on the TGA website at:

www.tga.gov.au/industry/ivd-application-audit.htm

Closing Thoughts

As always, we welcome any feedback or suggestions you may have on these eJournals.  Also, if Australia is a market of interest, please let us know as Emergo Group certainly serves as an Australian Sponsor as well.

Best regards,

Evangeline Loh, PhD, RAC
EMERGO GROUP | Vice President of Regulatory Affairs