Author: Keely So, Senior Manager, Medical Devices / IVD PharmaLex Australia
The Association of Regulatory and Clinical Scientists (ARCS) Annual Conference, a flagship event for the medical technology and pharmaceutical industry in Australia,took place in Sydney from 6 to 8 June and was attended by regulatory professionals to discuss developments and updates across the industry. PharmaLex presented several topical sessions including one on “Practical implementation of IVDR and its impact in Australia”.
Key discussion points were:
IVDR Impact in an Australian context
While transitioning from the In-Vitro Diagnostics Directive (IVDD) to the Regulation (IVDR) undoubtedly presents challenges for industry, manufacturers and sponsors who already commercialize IVDs in Australia may be in an advantageous situation. Australia’s Therapeutic Goods Administration (TGA) has operated a rules-based risk classification and conformity assessment framework since July 2010. In contrast, these concepts were only recently adopted under the new European IVDR framework. As a result, approximately 90% of IVDD-based devices will now require Notified Body conformity assessment at a level commensurate with IVD risk class. Products will be scrutinized during Notified Body reviews meaning transitioning manufacturers must ensure their technical documentation is robust and complete.
In terms of the impact of IVDR within an Australian context, sponsors should have a core set of technical documentation already in place, as elements would have been audited by the TGA during the Australian Register of Therapeutic Goods (ARTG) inclusion process. That same set of core documentation can be leveraged by incorporating Europe-specific requirements, potentially reducing overall efforts to demonstrate IVDR compliance.
Challenges of Transitioning to IVDR
Key challenges of IVDR transition pertain to Notified Body availability and workload associated with achieving compliance:
- Only 17% of IVDR applications have been granted certification as of October 2022. Although lack of Notified Body availability was historically an issue, we are starting to see an increase in resources and capacity to support manufacturers.
- Manufacturers must ensure evidence within their technical documentation satisfies the more prescriptive General Performance and Safety Requirements. New post-market surveillance (PMS) regulations have also been introduced with requirements for Summary Safety and Performance, Periodic Safety Update and Post-Market Performance Follow-Up report as part of a proactive approach towards PMS.
Alternatives to IVDR
IVDR certification is not a mandatory requirement towards ARTG applications. Depending on the IVD classification, Australian sponsors have options to leverage alternative evidence such MDSAP certificates alone or together with clearances from TGA-recognized authorities. The option of direct TGA conformity assessment is also available.
IVDR Implementation Approach
IVDR implementation can be complex as it requires updates to the manufacturer’s technical documentation and quality-management system processes. It is crucial that manufacturers fully understand the requirements and formulate implementation strategies specific to their business. These strategies should include gap assessments, periodic progress reviews, staying updated on the latest Medical Device Coordination Group (MDCG) guidelines and timing considerations for Notified Body engagement.
The leap to IVDR is undoubtedly significant however Australian manufacturers and sponsors already supplying IVDs in Australia should feel optimistic. Simultaneously, it is important to take a proactive approach towards IVDR implementation, keeping in mind the timelines, resourcing and efforts required to achieve compliance.