Reserve your spot and experience a facilitated discussion regarding solutions to your regulatory challenges. To reserve your spot you must select it during registration: Visit the website to modify your registration! Due to popular demand, space is limited to 20 people per solutions circle. There is no fee, but reservations are required. Open to paid delegates only.
Description: The following proposal aims to specifically help manufacturers at various steps of the conformity process. It also allows manufacturers that have a specific question on on area to only attend the relevant circle. It also provides the opportunity for SME’s or manufacturers of novel devices to attend all circles and learn from the questions and interactions from manufacturers and Notified bodies.
This solution circle is number 3 of a series of 3 solution circles related to IVDR topics.
Regulation EU 2017/746 on in vitro diagnostic (IVD) medical devices (IVDR) has either increased or introduced new requirements for IVD medical devices in several areas such as a rule-based classification system, performance evaluation, and post-market surveillance requirements. It also introduced more prescriptive requirements concerning the definition of the device's intended purpose.
The aim of this solution circle is to give manufacturers the opportunity to ask questions to NB representatives on their expectations regarding post-market surveillance and post-market performance follow-up under the IVDR.
After a brief introduction to the topic, participants will be encouraged to ask their questions for an open discussion with NB representatives and industry peers.
Participants will be reminded that NB are not allowed to consult and therefore the discussions will focus on what are the requirements and the expectations rather than how the implementation should occur.
This session will include representatives from four notified bodies.
Learning Objectives:
By joining this solution circle, participants will be able to ask questions on the requirements and expectations conerning post-market surveillance and post-market performance follow up to representatives of Notified Bodies as well as exchange with industry peers
Upon completion of this session, participants will have a clear understanding of the IVDR requirements and NB expectations concerning post-market surveillance and post-market performance follow-up
