Principal Consultant, QA/RA and IVD Expert Qserve Group
Many manufacturers make them, however, there seem to be lots of different interpretations and confusion of what is and is not a kit or procedure pack. There are even more interpretations on what manufacturers are required to do to place them on the EU market under the IVDR or MDR. It is important that manufacturers correctly identify if kit or procedure pack requirements apply to them in order to ensure that the correct regulatory requirements are followed. In this solution circle, attendees will be asked to share challenges and offer solutions to ensure compliance with the kit and procedure pack requirements under the EU IVDR and MDR. Attendees will have an opportunity to describe kit and procedure pack scenarios that fall within and outside of the scope of the MDR and IVDR. Beyond the written requirements, participants will be asked to provide practical advice to assist in determining the best way to manage contracts with suppliers, as well as approaches to place these devices on the EU market.
Learning Objectives:
Learn from colleagues practical advice and strategies to meet the requirements for kits and procedure packs under the EU IVDR and MDR.
Identify what is a kit / procedure pack vs. a device in its own right.