PreAnalytiX, a joint venture between BD and QIAGEN, has successfully passed the EU Notified Body inspection of its Quality Management System (QMS) according to ISO 13485 and compliance to the new EU IVDR 2017/746 for In Vitro Diagnostic Medical Devices (IVDR). In April, PreAnalytiX furthermore received the EU QMS Certificate pursuant to the IVDR for Class A in vitro diagnostic medical devices in sterile conditions. This Certificate is required for our PAXgene blood collection tubes containing stabilization additive when introducing them as IVD compliant to the new EU IVDR.
As a leader in innovative, integrated and standardized pre-analytical systems for sample collection, stabilization, transport, storage and purification of high quality nucleic acids, we are committed to compliance with the new EU IVDR. We develop new technologies and products according to current pre-analytical ISO and CEN Standards, fulfilling state-of-the-art requirements in the IVDR. We are ready and committed to support our customers and implement their needs to meet the new IVDR pre-analytical requirements such as sample collection, preservation, stability, storage and transport.
The IVDR is the new EU regulatory basis that came into force on 26 May 2017 over a 5-year transitional period for manufacturers developing, manufacturing and selling IVD devices into Europe and for health institutions developing and using in house devices for in vitro diagnostics. IVDR will replace the EU's current Directive on in vitro diagnostic medical devices (98/79/EC, IVDD).
The new regulation contains a series of very important improvements to modernise the current system. Among them are stricter upfront risk-based controls in devices including a new classification system and increased Notified Body involvement in in vitro diagnostic medical device approvals, improved transparency through a comprehensive EU database of medical devices and a device traceability system based on a unique device identification. The new regulation contains reinforcement of the requirements for scientific and clinical evidence, new requirements for specimen / pre-analytical workflows, strengthening of post-market surveillance requirements, enhanced requirements for health institutions’ in house devices, and improved coordination mechanisms between EU countries for vigilance and market surveillance.
The value IVDR brings to the European healthcare systems is expected to be huge, resulting in a high level of protection of health for patients, high standards of quality and safety for in vitro diagnostic medical devices, and increased competitiveness of European healthcare and industry.
We at PreAnalytiX are ready and actively committed to the new changes in the regulatory landscape for IVD medical devices and fulfilling all regulatory requirements. Although IVDR brings in significant changes, we believe these changes are for the better and will showcase our performance further. PreAnalytiX forms partnerships with customers to support their journey in attaining compliance, aside from ensuring our customers are not negatively impacted by the transition process and challenges ahead. We are committed to making our products fully compliant, enabling our customers to meet the new higher standards for diagnostic testing.