As the in vitro diagnostic (IVD) medical device industry is set to feel the impacts of a new IVD Regulation, the Irish and UK IVD industry gathered at the Citywest Hotel Dublin to assess the changes. IVD Manufacturers and pharmaceutical companies were represented at the All-Ireland IVD Symposium, hosted by ARC Regulatory, on 4th May. The expert Speaker panel included representatives from three of the major Notified Bodies, UL, NSAI and BSI; the British In Vitro Diagnostics Association (BIVDA), and ARC Regulatory.
The timely meeting coincided with the recent publication, in the Official Journal of the European Union (OJEU), of the final text of the IVD regulation. Entering into force on 25th May, and marking the start of the 5-year transition period, the clock is now ticking for the industry to prepare for the changes ahead.
Seamus Kearney, CEO of ARC Regulatory, organisers of the Symposium, and who led the afternoon Companion Diagnostics workshop, said:
“Working closely with IVD and CDx companies, and understanding the significance of the changes coming down the line, we wanted to provide an opportunity for the industry and other stakeholders to come together and engage on a subject that is going to create a seismic shift in how IVD devices are regulated. Workshops in particular, which took place in the afternoon and were tailored for the IVD, LDT and CDx sectors, provided a platform for an open and honest sharing of concerns and challenges. Many issues were covered, but one apparent outcome of the day’s discussions was the need for immediate planning across all functions. ARC Regulatory, with our focus on the IVD and CDx industry, bring significant expertise to organisations seeking external support in their journey towards continued EU compliance.”
Sue Spencer, Global Service Director – Regulatory at UL, who led the afternoon IVD workshop, commented:
“What manufacturers need to recognize quickly is that the change to regulations is not merely a revision. The scope of the regulation now includes most of the legacy IVDs that were previously exempt under the old scheme. This scope increase means that even those legacy devices will need to comply with all the technical file requirements, including expanded clinical evaluation and risk management. Companies need to work with their Notified Body as soon as possible to assess potential impact both in time and resources. UL continues to staff in anticipation of the increase in technical file reviews.”
Susan Murphy, European Medical Device Operations Manager at the National Standards Authority of Ireland (NSAI), said:
“NSAI, as the Irish Notified Body, will work to assist industry as the regulatory landscape changes. 80% of manufacturers will now require Notified Body intervention to ensure their products meet the essential requirements of 2017/746 to allow access to the EU Marketplace. Manufacturers must review their quality management systems and technical file dossiers against the requirements of the IVDR, develop a gap analysis and initiate plans to ensure compliance by full application in May 2022.”
Doris-Ann Williams, of the British In Vitro Diagnostics Association, added:
“BIVDA will be assisting member companies to understand the new requirements while also keeping them abreast of changes relating to the UK exiting the EU. Companies also need to think of the impact throughout their organisation and distribution chain.”
For more information on the regulatory support available to the IVD and CDx industry, please visit www.arc-regulatory.co.uk
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