Progress Report: September 2010

Are Changes Coming to the IVD Directive? Europe Commission Initiates “Public Consultation”

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The European classification of IVD Medical Devices under Directive 98/79/EC faces criticism for being seen as rigid and unable to address new technologies or practices. Could a change in the rules be coming?

The European Commission has launched a “public consultation” on the In Vitro Diagnostic Directive (IVDD), which has been in place since 2003. LNE/G-MED participated with other notified bodies in a joint response. We invite you to submit your opinion by the deadline of September 15, 2010 the European Commission site. (See URL at bottom.)

This month’s newsletter explains the current IVD assessments procedures, examines the approach taken by the Global Harmonization Task Force (GHTF) and identifies the other IVD elements under review.

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Current IVD Assessment Procedure

Under the In Vitro Diagnostic Directive (IVDD), medical devices are categorized based on whether they are specifically listed in Annex II of the directive (list A for the most risky devices, list B for lower risk devices) and whether they are intended for self-testing. Open a chart (like the one on right) showing assessment routes.

Devices fall into one of the following categories:

• List A devices are of particular importance for blood transfusion or graft transplantation.
• List B devices present a lower level of risk but still relate to the diagnostic of critical pathologies or state of health and must demonstrate their sensitivity, specificity and other attributes related to reliability.
• Self Testing devices deserve particular attention because of the higher potential of misuse, misinterpretation of the test result or test failures with significant impact on the medical decision that the test result may lead to.
• An Other category covers devices that don’t fit into any of the above groups.

See the chart above which summarizes the current CE Marking assessment routes that a manufacturer may chose, depending on the status of its IVD medical device.

 

Pros & Cons of Europe’s Approach Compared to Others

The main benefit of using explicit listings is the clarity of the process. Either the device is clearly listed or it falls under the “others” category. With limited room for interpretation, the system tends to be straightforward and convenient.

The U.S. regulation, which also uses lists, prescribes a more comprehensive listing of over 1,000 product codes, with specific product types being assigned based on risk to Class I, II or III.

Critics of the Directive 98/79/EC classification system point out the perceived arbitrary nature as to whether something is listed or not, along with the inability to effectively address new technologies.

An approach based on classification rules, related to intended use and other critical attributes, gives more flexibility with regards to new technologies. (See details of GHTF system in sidebar.)

The downside of the classification rule approach is the difficulty of covering all devices in an unambiguous way.

Other IVDD Issues Under Review

The public consultation also addresses other topics related to Directive 98/79/EC, including:

• Conformity Assessment: Should the current assessment routes be modified with the adoption of an IVD classification system?

 

 

• Scope: Should “in-house test” remain excluded from the scope of the revised IVD directive? Should the scope be clarified regarding genetic tests, diagnostic services performed by the manufacturers themselves or near-patient in vitro diagnostic medical devices?

 

To submit your opinion, go to the European Commission site by the deadline of September 15, 2010. The direct URL is: http://ec.europa.eu/consumers/dyna/newsroom/itemlongdetail_en.cfm?item_id=25&tpa=164&type_id=5

 

 

 

 

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