Impact of the New European IVD Regulation on Medical Laboratories - Opportunities and Challenges

Folker Spitzenberger
University of Applied Sciences Luebeck, Germany

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Folker Spitzenberger (Presenter) University of Applied Sciences Luebeck

Presenter Bio: Since 2016, Folker Spitzenberger is Professor for Regulatory Affairs for medical devices at the University of Applied Sciences, Luebeck, Germany.

He holds a diploma in chemistry, a PhD in molecular biology and a Master degree in drug regulatory affairs (M.D.R.A).
Besides his position at the University, he regularly works as quality assessor in the field of accreditation and notification for medical devices, especially IVD medical devices.
For numerous year, Folker Spitzenberger also works as quality and regulatory affairs consultant for international organisations such as WHO, the EU and others.

Relevant Financial Disclosures (within past 24 months) Committee/Board/Advisory Board ISO TC 212, ISO TC 210, DIN, CEN TC 140 Salary DAkkS, ZLG Discussing Products? NO, presenter will NOT present educational content related to products/services of the ineligible company(ies) listed above. Conflict mitigation NOT REQUIRED.

The current regulatory rules governing in vitro diagnostic medical devices (IVDMD) in the EU are mainly represented by the European IVD directive dating back from 1998. This directive does not cover devices with characteristics related to newer techniques and applications in current in vitro diagnostic testing, lacks conformity with current international consensus with regard to the risk-based classification of IVDMD, lacks transparency with regard to the identification and labelling of IVDMD and lacks requirements for laboratory-developed tests (LDT).

To solve these and other shortcomings, the the current IVD Directive will be replaced by the new Regulation (EU) 2017/746 ("IVDR") which entered into force in May 2017 with a transition period of five years.

The scope of the regulation includes newer technologies such as, for example, POCT devices and companion diagnostics.

The classification of IVDMD according to the IVDR will follow new classification rules on the basis of a risk-based classification system including 4 risk classes: A (lowest risk class), B, C and D (highest risk class).

As consequence, the involvement of Notified Bodies in the conformity assessment of IVDMD will increase significantly in the future.

Manufacturers will be obliged to register themselves and the devices in a central European database (Eudamed). Of note, manufacturers of higher risk devices (Classes C, D) will be obliged to make publicly available a so called summary of safety and performance including key elements of the supporting clinical data of a device. This might increase the extent of information of device performance data that are currently often lacking in the perspective of medical laboratories.

The new IVDR requirements for LDT represent challenges for medical laboratories and interpretation of these requirements is necessary to guarantee adequate care for patient groups with specific needs in medical laboratory diagnostic testing.