On 4 May, the in vitro diagnostic medical device industry will gather in Dublin for an All-Ireland IVD Symposium on the new European regulation.
Ireland flag
With an estimated value of nearly £10 billion within Europe, now there has been a formal acceptance of the new IVD regulation the IVD medical device industry anticipates it will be impacted. A wide range of devices are encompassed under the umbrella of IVD medical devices including pregnancy tests and blood sugar monitoring systems for diabetes.
“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,” explained Seamus Kearney of ARC Regulatory, organisers of the event. “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, National Standards Authority of Ireland (NSAI), UL and British Standards Institution (BSI). It is the first All-Ireland event of its kind for the IVD industry and we are very much looking forward to bringing the IVD industry together in a context of education and collaboration.”
Mani Subramani, head of business support, Prestige Diagnostics UK; Alan Rodgers, managing director, Prestige Diagnostics UK; Brendan McGuigan, Life Sciences client manager, Invest Northern Ireland; Seamus Kearney, ARC Regulatory CEO; Han Yan, business development executive, Biopanda Reagents
IVD Symposium
“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,” added Susan Murphy, NSAI’s European Medical Device operations manager. “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 place on the EU market. NSAI as a Notified Body, designated by the Health Products Regulatory Authority (HPRA), will liaise with industry (whilst not consulting), to ensure companies are aware of the changes and the impact on their industry.”