This document will help you understand whether your products falls under the definition of systems and procedure packs as per the 1993 Medical Device Directive (MDD) and the new 2017 Medical Device Regulation (MDR), how to classify your product and which actions to take to get on track for compliance with new MDR requirements.
A preview of the Guidance for EU MDR – Systems and Procedure Packs is available here:
You may purchase the full document in convenient Microsoft Word format including instructions for use below.