Location: Online webinar

Description: Regulation (EU) 2017/746 on in vitro daignostics, which came into force in May 2017 with a transition period of five years, is intended to strengthen the current approval system for IVDs and makes substantial changes to the existing IVD Directive (98/79/EC). The Regulation introduces a new risk-rule classification system based on the Global Harmonization Task Force rules which, for the first time, takes patient impact into consideration. This will have a significant impact on all manufacturers of IVDs as about 80% of all devices will now require some form of conformity assessment by a Notified Body. This seminar will clarify the requirements applicable to IVDs under the new Regulation, highlight the major changes to responsibility and product data expectations, and provide a thorough understanding of the impact on the industry.

Organiser: Management Forum

Contact: +44 (0)20 7749 4730