Life on the A List

Tuesday, November 09, 2010

I began my career in regulatory affairs in the late 90s. The IVD Directive had just been published and it was the big buzz around my company and I'm sure it was like that at many companies. I remember attending several training sessions and it still did not make sense. I figured it would make sense once I went through the process of CE Marking our IVD products.

Fast-forward twelve years and I still have to thumb through the IVD Directive to refresh my memory every time I'm helping a client work through their EU regulatory strategy.

One of the first things I check is if the product I'm working on is listed in Annex II of the IVD Directive. Annex II provides a categorization of products that require more than self-certification prior to CE marking. In all cases, every device must conform to the Essential Requirements laid out in Annex I. This results in what has been termed "self-certification" where manufacturers can issue a Declaration of Conformity and apply the CE Mark to their IVD without intervention of the Notified Body. Annex II lists high-risk devices that have been categorized as List A or List B and require conformity procedures above and beyond the essential requirements of Annex I including intervention with the Notified Body.

List A products are considered to be of the highest risk to public and individual health, which is similar to the premarket approval requirements (PMA) for Class III medical devices.

List A devices include IVD devices that are used for blood transfusions or transplantation. I've included the List A category description from Annex II below:

  • Reagents and reagent products, including related calibrators and control materials, for determining the following blood groups: ABO system, rhesus (C,c,D,E,e) anti-Kell
  • Reagents and reagent products, including related calibrators and control materials for the detection, confirmation and quantification in human specimens of markers of HIV infection (HIV 1 and 2), HTLV I and II, and hepatitis B, C and D.

List A product manufacturers may choose from the following conformity assessment routes.

  1. Annex IV – EC Declaration of Conformity
    1. Quality System Assessment by Notified Body
    2. Design Dossier Examination by Notified Body
    3. Verification of Manufactured Products

    OR
  2. Annex V (EC Type Examination) and Annex VII (EC Declaration of Conformity)
    1. Technical File Examination by Notified Body
    2. Examination and test of representative samples by Notified Body
    3. Production Quality Assurance by Notified Body
    4. Verification of Manufactured Products

I recommend that you work with your authorized representative and notified body to choose the best conformity assessment route(s) for your device.

Tags: EU, Ex-US, IVD, PMA

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