Preparing for IVDR Certification

In May 2017, the In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746 was formally published in the Official Journal of the European Union (OJEU), and the date of application was May 26, 2022. The IVDR significantly expanded the IVDD and established a rule-based classification system. Although most IVD manufacturers still have until 2025 or later to fully transition the IVDR, the majority will face significant challenges in carrying out the updates to their quality management systems (QMS) and technical documentation needed to prepare for certification through a Notified Body.

About the presenter

Ken Pilgrim, manager, Quality and Regulatory Affairs 

Prior to joining Emergo by UL, Ken Pilgrim had over 20 years of IVD and medical device industry experience at the manager/ director level, overseeing corporate QMS and providing input on business decisions and strategy, regulatory oversight, and risk management strategies for existing and new products.  His expertise includes international regulatory compliance, support and strategy — specifically for the EU (MDR/IVDR), US (FDA 510(k) clearances and other activities) and Canada (Class II–IV Medical Device Licenses for Health Canada) — and incorporation of risk management processes. Additionally, Pilgrim has implemented numerous QMSs to FDA QSR, ISO 13485/MDSAP and EU requirements and conducts global audits to assist companies in verifying their compliance with requirements or preparing them for upcoming certifications.