The demand for in-vitro diagnostic medical devices (IVDs) and medical devices (MDs) is increasing rapidly, driven by personalized medicine and the need for early and accurate diagnosis. The selection of right patient with the right treatment at the right time increases the analytical and clinical performance requirements for IVDs and MDs, and this has resulted in significant regulatory reforms of medical devices in the European Union (EU).
In 2017, the EU adopted the Regulation on in vitro diagnostic medical devices (IVDR, 2017/746/EU) and the Regulations on medical devices (MDR, 2017/745/EU). The goal of the IVDR and MDR is to bring EU legislation into line with technical advances in the biomedical field and promote higher levels of evidence before medical devices are approved in Europe. The new Regulations will create a robust and transparent framework that improves clinical outcome, promotes patient’s health and impacts cost-effectiveness of treatments. The European IVDR and MDR will have major impact on the medical technology industry as essentially all products falling under the scope of the IVDR will require new or re-certification of devices. A study commissioned by the Dutch government estimated that 85% of the IVDs will need to be IVDR re-certified by a Notified Body and that 78% of the IVDs on the market need to be CE certified by a third party. There is a transition period up to 22 May 2025 for companies with IVDs to comply to these new EU Regulations.
Demonstrating conformity with the IVDR and/or MDR, will require the provision of data that use samples with defined and standardized quality concerning clinical characteristics as well as pre-analytical parameters such as ischemia duration, transport duration, fixation condition for which the performance of an IVD has to be shown. This will be required to improve the accuracy (sensitivity and specificity) of the biomarker, and more in particular for companion diagnostics, thereby generating a positive benefit-risk balance for the patient. These requirements can only be achieved by using samples collected in top level medical centers and processed under standardized pre-analytical conditions, as defined for example in the pre-analytic ISO and CEN standards and stored in certified or accredited biobanks.
HALO Research Technology BV or HALO is established in The Netherland with an affiliated branch office in the United Kingdom. HALO provides services and expertise required to accelerate development and validation of biomarkers in conformity with the IVD Regulation. HALO provides access to analytical and clinical performance testing in close collaboration with the Medical University Graz and its biobank as well as with the Graz University of Technology, the EU Reference Center of Medical Devices, and other Universities and medical centers that are associated with the European Biobanking Research Infrastructure BBMRI-ERIC. HALO integrates a series of key assets that jointly will provide unique services to customers:
- Access to the best biobanks in Europe
- High level expertise in the development and implementation of European and ISO Standards relevant for IVDs and MDs
- Pre-analytical, analytical, and clinical expertise
- Established collaboration with networks of leading universities and medical centers
HALO will serve as one stop shop for planning and execution of different types of analytical and clinical performance studies with leading medical centers and biobanks and serves as a R&D service organization with special focus on IVDs and MDRs. The spectrum of expertise includes but is not limited to molecular in vitro diagnostics for cancer including companion diagnostics. Furthermore, the analytical spectrum covers molecular infectious disease diagnostics including detection of high-risk pathogens.
If you are interested in these services, please contact:
Donald de Korte (donald@halo-research.com) or Alan Boyce (alan@halo-research.com)
