Thursday marked the date of application of the in vitro diagnostic regulation. This regulation applies to IVDs placed on the market in the European Union and Northern Ireland, bringing with it a heightened regulatory regime.
BIVDA have released a full press release to celebrate this new chapter of IVD regulation. Please see the text below:
BIVDA welcomes the In Vitro Diagnostic Medical Devices Regulation and urges continued work to deploy the new regulatory system.
The IVDR represents a revolutionary overhaul of the regulatory requirements: a strengthened notified body system which must assess about 70% of IVDs for the first time, a new risk classification system, updated clinical evidence requirements, a new post-market system, a new database enabling more transparency (EUDAMED), a unique device identification system facilitating supply chain traceability, and more.
An amendment to timelines within the Regulation was published in January 2022. This was implemented due to the Covid-19 pandemic and the low number of Notified Bodies designated for the IVDR in Europe. This amendment grants three to five additional years, depending on the risk classification of the IVD.
The amendment has not addressed all challenges, however. Today, as the date of application is met, the incomplete IVDR infrastructure poses critical ongoing risks that need urgent resolution, e.g:
– to ensure both innovative and updated devices can be certified under the IVDR and reach patients and healthcare systems.
– to make the regulatory systems fully operational to certify the highest risk IVDs and companion diagnostics (including those needed to manage infectious diseases and diagnostics to support personalised medicines).
– to urgently designate and build considerably more Notified Body capacity to support certification of all IVDs and reduce the long and unpredictable certification timelines we have today.
– to build other system infrastructure needed to implement the IVDR including requirements for performance studies, post-market and vigilance and EUDAMED database, etc.
Such challenges need ongoing attention and work by competent authorities across Europe if Europe is to ensure a workable system both today and over the longer term.
BIVDA Regulatory Affairs Manager, Ashleigh Batchen said “The IVDR has been hugely anticipated and was needed to strengthen the regulatory landscape for IVDs. Although it increases the workload for economic operators, we all need to remember the core reason for this: to keep IVDs safe and effective for patients. We still have a long way to go, and BIVDA encourages all our members to continue pushing to ensure IVDR compliance.”
BIVDA Chief Executive Office, Doris-Ann Williams said: “BIVDA welcomes the IVDR date of application, and we will continue to support our membership on regulatory matters as needed to ensure compliance. It is a monumental milestone for our industry that couldn’t have been done without hard work from across the whole sector.”
BIVDA will continue to work with the Medicines and Healthcare products Regulatory Agency and other key stakeholders to rapidly propose solutions to avoid disruptions in the supply of life-saving diagnostics.