The HPRA is actively seeking expressions of interest from national laboratories to be designated as European Union (EU) reference laboratories for performance and compliance testing of Class C and Class D in vitro diagnostic medical devices (IVDs). European Union reference laboratories will be required to verify compliance of such IVDs with the applicable common technical specifications, when such common technical specifications are available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent.
Expressions of interest are welcomed by 31st January 2017, from national laboratories which meet the specified criteria outlined in Article 78 of the Regulation on in vitro diagnostic medical devices, IVDR (Ref. ST. 11663/16).
The HPRA will communicate the expressions of interest on an informal basis to the European Commission and the IVD technical group (the European Commission’s expert working group on IVDs).
The proposed IVDR has reached political agreement and is expected to be adopted in Q1 2017
For further information and detail please visit our dedicated web page National call for Reference Laboratories for IVDs