In a review report, experts of the Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines jointly with a colleague of the World Health Organization (WHO) summarise the most important changes introduced by the new in vitro diagnostic medical devices regulation, which will come into force in May 2022. In this context, the focus is on the tests used for blood donations. Another subject of the publication refers to the most important elements of the pre-qualification program for in vitro diagnostic medical devices. The report is published in the Journal Vox Sanguinis and is available as full text.
Blood transfusions are indispensable as routine therapeutic treatment. High requirements must be fulfilled with regard to quality and safety of transfused blood components. These are achieved by a number of different measures, including a questionnaire, which blood donors must complete in order to exclude persons from risk groups from the donation. The screening of the blood donations for infectious agents also contributes to the quality and safety of the blood products. The screening tests used are subject to the European regulations for in vitro diagnostic medical devices (IVD).
In the European Union, Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 replaces the existing IVD Directive. The five-year transition period ends on 26 May 2022. Experts of the Paul-Ehrlich-Institut, jointly with the IVD pre-qualification team led at the WHO, have summarised the most important changes concerning testing and marketing authorisation of in vitro diagnostic medical devices in the new IVD regulation. Besides, the review covers the major elements of the pre-qualification of in vitro diagnostic medical devices introduced by the WHO.
One of the various changes included in the future IVD regulation, which must be implemented as per May 2022, is the new classification of IVDs that goes hand in hand with a markedly improved depth of evaluation. Thus, IVDs of the highest risk category - which will also include tests for coronavirus SARS-CoV-2, currently not yet regulated in the EU – will have to be investigated by an EU reference laboratory. The results of the reference laboratory must then be taken into account by the Notified Body before a decision is made on whether or not they will be granted a CE label.
The Paul-Ehrlich-Institut has several decades of experience in evaluating IVDs and is currently applying for the status of an EU reference laboratory. In addition, the Paul-Ehrlich-Institut supports authorities in African partner countries in establishing regulatory structures for blood transfusions, including the regulation of IVDs. This project is supported by the Federal Ministry of Health (BMG). The review referenced here will also be useful for the partner countries, by supporting them in their decision-making process based on the comparative description of the various regulatory approaches.
Updated: 20.10.2020
