The in vitro diagnostic medical device industry is set to gather in Dublin on 4 May for an All-Ireland IVD Symposium on the new regulation. The timing of the event comes as Europe formally adopts the IVD regulation. With an estimated value of almost £10 billion in Europe, the industry is set to feel the impacts of a new regulation. IVD medical devices constitute a wide range of tests including pregnancy tests, and blood sugar monitoring systems for diabetes.
Seamus Kearney of ARC Regulatory, organisers of the event, said:
“The All-Ireland IVD Symposium in Dublin has been organised to help IVD companies prepare for the new regulation, and gain access to Notified Bodies. It is believed around 90-95% of IVD companies will need a Notified Body as a result of the new regulation, so we have invited representatives from three of the major Notified Bodies, NSAI (National Standards Authority of Ireland), UL and BSI (British Standards Institution). It is the first All-Ireland event of its kind for the IVD industry, and we are all very much looking forward to bringing the IVD industry together in a context of education and collaboration.”
Susan Murphy, NSAI’s European Medical Device Operations Manager, said:
“The upcoming regulations are to ensure Europe is at the forefront of the regulatory market, ensuring the safety and performance of devices for the European patient population. The IVDR will bring more control to the IVD industry ensuring better risk classification and better device regulation, with an independent review of approximately 80% of IVD’s placed on The EU Market. NSAI as a Notified Body, designated by the HPRA (Health Products Regulatory Authority), will liaise with industry (whilst not consulting), to ensure companies are aware of the changes and the impact on their industry.”
Seamus Gorman, of Dublin-based HiberGene Diagnostics, said:
“HiberGene sees this symposium as an ideal and timely opportunity to engage in discussions on the imminent changes and challenges, now that the long-awaited approval of the IVDR has arrived.”
Alan Rodgers, Managing Director of Co. Antrim-based Prestige Diagnostics UK Ltd, said:
“Specialising in the manufacture of IVD clinical diagnostics assays, and point of care products, the new IVD regulation will no doubt impact how Prestige Diagnostics operates. We look forward to the opportunity of learning more about the impacts, and meeting Notified Bodies on 4 May. Prestige Diagnostics congratulates ARC Regulatory for bringing this one-of-a-kind event to Ireland.”
Companies wishing to register for the Symposium on 4 May should visit www.arc-regulatory.co.uk.