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 allow manufacturers that have a specific question on on area to only attend the relevant circle. It also provides the opportunity for SME’s or manufactuers of novel devices to attend all circles and learn from the questions and interactions from manufacturers and Notified bodies.
This solution circle number 1 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 post market surveillance requirements. It also introduced more prescriptive requirements concerning the definition of the device intended purpose. The aim of this solution circle is to give manufacturers the opportunity to ask questions to NB representatives on their expectations regarding device intended purpose and classification under the IVDR. After a brief introduction of 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
Focus of the discussion: Intended purpose, device classification, list of codes and corresponding types of devices /sampling TD under the IVDR
Learning Objectives:
By joining this solution circle, participants will be able to ask questions on the definition of a device intended purpose, classification, NB code assignement and creation of sampling groups 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 the topics above
Upon completion of this session, participants will be able to write IVDR compliant intended purposes, correctly classify the devices and assign relevant NB codes
