EU Notified Body designated under Regulation (EU) 2017/746 (IVDR)

Descriptions

NHS Blood and Transplant (NHSBT) is seeking to engage with an EU Notified Body designated under Regulation (EU) 2017/746 (IVDR) to undertake conformity assessment of in vitro diagnostic medical devices (IVDs) and appropriate surveillance of legacy IVDs. NHSBT is a Special Health Authority that provides a blood and transplantation service to the NHS, looking after blood donation services in England and transplant services across the UK. NHSBT Reagents is a specialist department within NHSBT that designs, manufactures and distributes in vitro diagnostic medical devices for transfusion and transplantation investigations including blood grouping control reagents. NHSBT’s current EU Notified Body has not been designated under the IVDR and we require the services of an alternative EU Notified Body for conformity assessment and CE-certification of IVDs under the IVDR, and for appropriate surveillance of legacy IVDs (i.e. IVDs that are covered by a certificate issued by a Notified Body in accordance with Directive 98/79/EC (IVDD) and which comply with the conditions set out in Article 110 (3c) of the IVDR). It is imperative that NHSBT is able to lodge a formal application for conformity assessment and sign a written agreement with an alternative EU Notified Body in accordance with deadlines set out in the Article 110 (3c) point (e) and Article 110 (3c) point (f) of the IVDR, respectively. This will enable NHSBT to benefit from the extended transitional period provided for in the IVDR, as amended by Regulation (EU) 2024/1860. The device risk class, IVDR transitional deadlines and number of devices / products are summarised in the tender documents. The EU Notified Body’s designation must cover the scope of designation applicable to the IVDs manufactured by NHSBT which is summarised as follows: • NBOG Codes that apply to legacy devices; IVD0101, IVD0102, IVD0302, MDS7210. • IVDR Codes that apply to the IVDR devices; IVR0101, IVR0102, IVR0103, IVR0104, IVR0105, IVR0106, IVS1004, IVT2006, IVT2008, IVT2009, IVT2011, IVP3001, IVP3006 (note: not all codes apply to all devices). NHSBT’s requirements are summarised below: • Surveillance assessment of legacy devices during the transitional period. • Assessment of NHSBT’s Quality Management System. • Undertake announced and unannounced audits. • Conformity assessment and CE-certification of NHSBT’s IVDs. • Surveillance assessment of IVDR CE-certified IVDs (following initial certification). • Batch / product verification for Class D devices. • Validate the Summary of Safety and Performance for Class D and C devices. • Assess and approve (or reject) proposed/planned substantial changes to NHSBT Reagents product range, products or Quality Management System.