Update on the latest changes to the IVDR application and implications for Lab Developed Tests

In May this year the in-vitro diagnostics regulation (IVDR) will replace the in-vitro diagnostics directive (IVDD) across the EU. The regulations have a broader scope than the previous laws and specifically include software and novel technologies such as genetic testing as well as devices manufactured and used within health institutions.

In addition, they introduce a new, risk-based classification system for IVDs. A Unique Device Identifiers (UDI) for certain products and a yet-to-be-established centralized database (EUDAMED) to collect and share information will be implemented. Manufacturers of commercial products are required to provide strong clinical evidence and establish a post-market surveillance system. Importantly, the percentage of IVD devices requiring notified body approval is going to increase to 90%.

Clinical MS users are affected by a lack of clear IVDR implementation guidelines and notified bodies for the certification.

We will discuss concerns regarding the risks of disruption of existing workflows due to the lack of complete IVDR solutions using pragmatic examples.

Presenter: Robyn Meurant (Principal Consultant, ACT-IVD)

Scientist with a passion for public health. Expert in IVD regulatory assessment. Extensive experience in regulation. Strong knowledge of IVDR and how to effectively implement it. Ms Meurant was the regulator of IVDs for the Australian Therapeutic Goods Administration, led technical documentation assessment and guidance development for WHO PQ, was the global lead for IVDs at NSF Health Sciences, and has been advising governments and NGOs during the COVID-19 pandemic. She has also extensive experience in regulatory capacity building. She commenced her career as a diagnostic scientist, heading the serology laboratories of several of the largest pathology providers in Australia.