- Published: 07 November 2016
In Vitro Diagnostic (IVD) Medical Device regulatory framework
The IVD Medical device regulatory framework comes into full effect on 1 July 2017. Administered by the TGA, the framework is designed to ensure all IVD medical devices, including in-house IVD medical devices, are to be notified to, or registered with, the TGA following a level of scrutiny commensurate with the risks associated with their use.
The TGA and NATA, in recognising the complementary nature of their respective responsibilities as regulator and laboratory accreditation authority, have reached an understanding about co-operating and exchanging information and material on matters relating to the accreditation of laboratories engaged in the manufacture of in-house IVD medical devices.
The practical outcome of the IVD Medical device regulatory framework is that post 30 June 2017, unless otherwise exempt, laboratories will not be able to offer testing using Class 1 - 3 in-house IVD medical devices unless that test is NATA/RCPA or NATA accredited and the laboratory has complied with the requirements for notification to the TGA.
Similarly, unless otherwise exempt, laboratories will not be able to offer testing using Class 4 in-house IVD medical devices unless that test is registered on the Australian Register of Therapeutic Goods (ARTG). Laboratories are required to apply to the TGA for registration of their Class 4 in-house IVDs before 1 July 2017.
It should be noted that the regulations apply to in-house IVD medical devices which have been developed from first principles, developed or modified from a published source and/or commercially supplied which have undergone modifications.
In addition, commercially supplied products sold as “Research use only” which are used by laboratories to test and report on patient samples are considered in-house IVDs (as they can affect diagnosis, treatment, or management of a patient). In these circumstances the laboratory must validate the assay as an in-house IVD for diagnostic use in line with the NPAAC Requirements. The use of disclaimers does not preclude the need for the laboratory to validate the assay.
In September 2016, NATA and TGA signed a Memorandum of Understanding (MoU) which clarifies each party’s role and responsibilities under the framework in relation to co-operation and the exchange of information.
The MoU recognises that NATA accreditation is available to any laboratory undertaking tests on human samples and that:
- Medical laboratories undertaking pathology tests may obtain NATA accreditation for compliance with the standard ISO 15189, Medical laboratories – particular requirements for quality and competence,
- in conjunction with assessment activities against ISO 15189, NATA undertakes an assessment of the manufacture and use of in-house IVD medical devices against the National Pathology Accreditation Advisory Council (NPAAC) standards including the NPAAC Standard, Requirements for the Development and Use of In-House In Vitro diagnostic Devices,
- in addition, NATA is able to assess laboratories (that are outside of the scope of ISO 15189) that manufacture Class 1 - 3 in-house IVDs for compliance with ISO/IEC 17025 and the NPAAC standard Requirements for the Development and Use of In-House In Vitro diagnostic Devices. Requests from laboratories for accreditation with NATA to ISO/IEC 17025 will be considered on a case by case basis. (In principle, assessment against ISO/IEC 17025 will only be considered in exceptional cases e.g. Veterinary laboratories primarily performing testing on animals but may also perform the test on human samples if requested).
Under the MoU NATA has agreed to a set of undertakings which include:
- that in the course of any assessment activity undertaken in relation to accreditation, NATA will require the laboratory to identify any in-house IVD medical devices;
- NATA will include all in-house IVD medical devices identified and put forward by the laboratory in the activities to be covered by the assessment;
- NATA will apply all the relevant clauses of ISO 15189 or ISO/IEC 17025;
- NATA will assess compliance of an in-house IVD medical device with the NPAAC standard Requirements for the Development and Use of In-House In Vitro diagnostic Devices. For in-house IVDs not previously assessed, NATA will focus on requirements relating to design, production and technical validation; for all other in-house IVDs NATA will focus on requirements relating to post market monitoring and reporting;
- NATA will assess that the laboratory has implemented a post market system that monitors the performance of that in-house IVD medical device, implements corrective action to address deficiencies in design production and includes a system for notifying the TGA of any adverse events arising from the use of the in-house IVD medical device;
- Upon becoming aware of an issue with a non-conformance by the laboratory with the post market notification requirements for an in-house IVD (eg, a non-conformance relating to the requirements for reporting an adverse event) NATA will provide TGA with any relevant information relating to the problem identified in relation to the in-house IVD
- Where TGA has raised a concern with the performance or competence of a NATA/RCPA or NATA accredited laboratory, NATA will promptly respond to these concerns and provide feedback on actions taken by NATA or the laboratory to address these concerns;
- If NATA becomes aware that a laboratory has manufactured Class 1 -3 in-house IVD medical devices that have not been notified to the TGA, NATA will advise the laboratory of their obligations under the Regulations;
- If NATA becomes aware that a laboratory has manufactured Class 4 in-house IVD medical devices that have not been included in the ARTG (and are not otherwise exempt), NATA will advise the laboratory of their obligations under the Regulations; advise the laboratory that they must desist from manufacturing and using the device; and to immediately notify the TGA. NATA will also notify TGA directly and provide details of the laboratory and of the Class 4 in-house IVD medical device.
Should you have any questions regarding NATAs undertakings with respect to the IVD Medical device regulatory framework please contact Tracy Fleming, Sector Manager or Andrew Griffin, Deputy Sector Manager - Legal and Clinical Services.